adam feuerstein: Welcome to TheStreet's live coverage of the FDA's Oncology Drug Advisory Committee (ODAC) meeting, which this morning will be discussing and reviewing Cell Therapeutics' lymphoma drug pixantrone. Cell Therapeutics is seeking approval for pixantrone as a singe-agent treatment for patients with recurring or refractory, aggressive non-Hodgkin's lymphoma (NHL) who have received two or more prior lines of therapy. I'm going to be live blogging the entire pixantrone panel meeting, so check back here often for updates. Monday March 22, 2010 7:45 adam feuerstein 7:49 adam feuerstein: A bit of background about today's FDA panel, how it works and a timeline: The ODAC panel consists of nine independent cancer experts brought together by FDA to review the clinical efficacy and safety data for pixantrone, then vote on whether to recommend the drug's approval, or not. The decisions made by the ODAC panel are non-binding, which means it merely makes a recommendation to the FDA, which has the ultimate authority to approve or reject drugs. Usually, the FDA goes along with the panel's recommendation, but that's not a hard-and-fast rule. Today's ODAC panel will kick off at 8 am with introductions and a short presentation by FDA at 8:15 am. Monday March 22, 2010 7:49 adam feuerstein 7:49 adam feuerstein: At 8:30 am, Cell Therapeutics and its representatives will present pixantrone data to the panel, followed by a more complete FDA presentation at 9:10 am. Panel members will query the presenters at 10 am, the public will be invited to speak at 10:30 am and the panel will begin deliberations and voting at 11 am. The whole shebang should be over by noon. Monday March 22, 2010 7:49 adam feuerstein 7:49 adam feuerstein: Cell Therapeutics shares closed Friday at 91 cents. The stock is halted for trading while the ODAC panel hears the pixantrone case. Monday March 22, 2010 7:49 adam feuerstein 8:00 Monday March 22, 2010 8:00 8:01 adam feuerstein: The panel is starting with introductions Monday March 22, 2010 8:01 adam feuerstein 8:05 adam feuerstein: conflict of interest statements being read now. boilerplate stuff. Monday March 22, 2010 8:05 adam feuerstein 8:06 adam feuerstein: FDA's Dick Pazdur makes a funny -- renaming ODAC as "SnowDAC" due to the storm that cancelled the previous meeting on Feb. 10. Monday March 22, 2010 8:06 adam feuerstein 8:10 adam feuerstein: FDA's Pazdur: his introductory remarks makes the point that the pixantrone study was not completed. Recall, CTIC only enrolled 140 patients out of a planned 320 patients. Monday March 22, 2010 8:10 adam feuerstein 8:10 adam feuerstein: Pazdur - FDA not consulted about halting enrollment in trial, not pre-specified in study's statistical plan. Only 8 patients in the U.S. were enrolled despite 28 sites. Monday March 22, 2010 8:10 adam feuerstein 8:13 adam feuerstein: FDA Pazdur: The primary endpoint of the study CR/CRu did not achieve the level of statistical significance. Secondary endpoints can not be analyzed or considered. Monday March 22, 2010 8:13 adam feuerstein 8:15 adam feuerstein: Pazdur is taking a very hard line against pixantrone in his opening remarks. The major concerns: 1. Is there "substantial evidence" of pixantrone's efficacy? 2. Are these results generalizable to the U.S. patient population? 3. Is pixantrone safe in light of increased rates of cardiotoxicity and febrile neutropenia in the pixantrone- treated arm? Monday March 22, 2010 8:15 adam feuerstein 8:16 [Comment From Joshua Joshua : ] Is he saying anything positive; all that seems to being said is negative, maybe true but negative......anything on the plus side? Monday March 22, 2010 8:16 Joshua 8:16 adam feuerstein: No. Pazdur is pretty much all negative on pixantrone. Monday March 22, 2010 8:16 adam feuerstein 8:19 adam feuerstein: Recall, according to CTIC, the pixantrone CR/Cru rate was 20% vs. 5.7% for the control arm. The results were statistical significant. But, when FDA did its own analysis, taking out patients who should not have been enrolled in the study, the CR/CRu rate for pix was 16.7% vs. 6% for the control arm and was not statistical significant. Monday March 22, 2010 8:19 adam feuerstein 8:20 [Comment From Tom Tom : ] Did CTIC reps give their comments to Padzur's questions? Monday March 22, 2010 8:20 Tom 8:21 adam feuerstein: CTIC has not yet started its presentation. The company and its doctors are up next, after Pazdur finishes. Monday March 22, 2010 8:21 adam feuerstein 8:22 adam feuerstein: FDA's Pazdur is done with his pixantrone whack. That was brutal. Monday March 22, 2010 8:22 adam feuerstein 8:23 adam feuerstein: Now, FDA is going over rules for patient access to unapproved drugs. The expanded access program. Monday March 22, 2010 8:23 adam feuerstein 8:24 adam feuerstein: FDA seems to be saying to panel members, even if you want to approve this drug for patients who have no other treatment options, we don't think you should. Patients who have no alternative therapies can get pixantrone under an expanded access program, if necessary. Monday March 22, 2010 8:24 adam feuerstein 8:26 [Comment From Phil Phil : ] This is like listening to Tokyo Rose give her play by play during the Pacific campaigns, and we all know how that turned out. Monday March 22, 2010 8:26 Phil 8:26 [Comment From biotraderman biotraderman : ] These people are dying for gods sake.. Give them hope.. They will approve Monday March 22, 2010 8:26 biotraderman 8:27 [Comment From Guest Guest : ] you have sat through a lot of these FDA meetings, is this one of the most negative openings Monday March 22, 2010 8:27 Guest 8:28 adam feuerstein: Pazdur was very negative, very forceful. The FDA's position is very clear. It will be up to CTIC to convince the panel members to recommend pixantrone's approval. Monday March 22, 2010 8:28 adam feuerstein 8:29 [Comment From Jonas Jonas : ] I sincerely hope they approve... people are dying while this meeting is progressing.... Monday March 22, 2010 8:29 Jonas 8:29 [Comment From dispassionate dispassionate : ] fda deals with data, not hope Monday March 22, 2010 8:29 dispassionate 8:30 [Comment From Chris Chris : ] Opening Comments from FDA are normally pretty Harsh,By design,Company is tasked with convincing Panel IMO Monday March 22, 2010 8:30 Chris 8:30 [Comment From Maswa Maswa : ] Adam, how much have bet you on the failure of the pix? Monday March 22, 2010 8:30 Maswa 8:30 adam feuerstein: I have no position in CTIC, long short or options. Never have. Monday March 22, 2010 8:30 adam feuerstein 8:31 [Comment From Danski Danski : ] Adam, you have been negative against Pix for as long as I can remember. Are you impartial today? Monday March 22, 2010 8:31 Danski 8:31 adam feuerstein: I will be giving you the play by play, pros and cons. Monday March 22, 2010 8:31 adam feuerstein 8:34 adam feuerstein: FDA wrapping up expanded access presentation. The FDA message was clear: in Don't approve pixantrone just b/c u think end-stage pats might want the drug. They will be able to get pix thru an expanded access program, if CTIC puts one in place. Monday March 22, 2010 8:34 adam feuerstein 8:34 adam feuerstein: CTIC presentation begins now Monday March 22, 2010 8:34 adam feuerstein 8:37 [Comment From charlie charlie : ] Thank you for being there adam and blogging for us ... Monday March 22, 2010 8:37 charlie 8:38 adam feuerstein: CTIC's CEO Jim Bianco: Giving opening remarks on pixantrone. going over the chemical structure of pixantrone, which is a novel anthracycline that is designed to decrease cardiac toxicity. Monday March 22, 2010 8:38 adam feuerstein 8:40 adam feuerstein: Bianco: FDA recommended CR/CRu rate as primary endpoint for the phase III study. This is the 1st study of NHL patients in the 3rd line setting. Patient accrual was slower and harder than expected. We took a lot of steps to boost enrollment over 3 yrs. In March 2008 after 140th patient was enrolled, study was closed to enrollment. We consulted with FDA about this. Monday March 22, 2010 8:40 adam feuerstein 8:41 adam feuerstein: Bianco: The statistical plan was unchanged except for sample size. Only one efficacy analysis was conducted. Trial integrity was maintained and CTIC was blinded to all data until the final analysis was conducted. Monday March 22, 2010 8:41 adam feuerstein 8:43 adam feuerstein: Bianco: Pixantrone achieved the study's primary endpoint, a significant increase in the CR/CRu rate. Patients did better in the longer-term followup and survival trend is encouraging. The adverse events are manageable. Monday March 22, 2010 8:43 adam feuerstein 8:44 adam feuerstein: Bianco: "We believe the totality of the data from this trial shows that pixantrone provides a favorable benefit to risk profile." Monday March 22, 2010 8:44 adam feuerstein 8:44 adam feuerstein: Now speaking, Dr. Owen O'Connor from NYU, giving an overview of aggressive NHL. Monday March 22, 2010 8:44 adam feuerstein 8:45 [Comment From Hermann Hermann : ] Adam, As someone who has followed you and CTIC for a while, I will respond to Danski by saying being negative has nothing to do with it. Its all about being accurate. Your negative points were also brought up by FDA. If the facts are negative, then you have to call it as you see it. Monday March 22, 2010 8:45 Hermann 8:46 adam feuerstein: O'Connor: NHL patients refractory to all currently approved treatments measure their lives in weeks, not years. Monday March 22, 2010 8:46 adam feuerstein 8:47 adam feuerstein: O'Connor: Most drugs used in 3rd line setting are experimental. Pixantrone is one of few drugs ever to be studied in 3rd line setting in a randomized, controlled study. Monday March 22, 2010 8:47 adam feuerstein 8:49 adam feuerstein: O'Connor: "Pixantrone establishes a new benchmark for future advances in this disease" Monday March 22, 2010 8:49 adam feuerstein 8:50 adam feuerstein: Up next. CTIC's chief medical officer, Dr. Jack Singer. He's reviewing the phase III study of pixantrone. Monday March 22, 2010 8:50 adam feuerstein 8:50 [Comment From JLambeth JLambeth : ] I'm confused why my input to this liveblog is not appearing Adam. Monday March 22, 2010 8:50 JLambeth 8:50 adam feuerstein: I appreciate all your comments and will post as many as possible. Monday March 22, 2010 8:50 adam feuerstein 8:53 adam feuerstein: CTIC's Singer: Going over the design of the phase III study and background on the patients right now. Monday March 22, 2010 8:53 adam feuerstein 8:54 adam feuerstein: Singer: Patients in study has median of 3 prior treatments for their NHL. Monday March 22, 2010 8:54 adam feuerstein 8:56 adam feuerstein: Singer: Updated results 24% CR/CRu for pix vs. 7% for the control arm Monday March 22, 2010 8:56 adam feuerstein 8:56 adam feuerstein: Singer: The response to pixantrone is durable, more durable than patients in the control arm. Monday March 22, 2010 8:56 adam feuerstein 8:57 [Comment From kwiknuts kwiknuts : ] adam how many death threats so far this am from CTIC crazies? Monday March 22, 2010 8:57 kwiknuts 8:57 adam feuerstein: None yet. everyone is being very nice. Thanks! Monday March 22, 2010 8:57 adam feuerstein 8:59 adam feuerstein: Singer: Pixantrone patients living longer, not statistically significant but trending in that direction. 21% reduction in the risk of death compared to the control arm. Monday March 22, 2010 8:59 adam feuerstein 9:00 adam feuerstein: Singer: "Totality of the evidence supports that pixantrone is more effective than the comparator agents." Monday March 22, 2010 9:00 adam feuerstein 9:04 adam feuerstein: CTIC's Singer: Going over pixantrone safety data now. 15 pix and 15 control patients died due to adverse events. but 9 control patients died due to progressive disease compared to 3 patients in the pixantrone arm. Monday March 22, 2010 9:04 adam feuerstein 9:06 adam feuerstein: Singer: Three pixantrone patients died due to cardiac failure, but patients had history of heart failure/toxicity. Only one of these patient deaths was deemed related to pixantrone. Monday March 22, 2010 9:06 adam feuerstein 9:06 [Comment From Dmitri Dmitri : ] Adam, whether I agree with you or not, you earn your paycheck, thank you for doing this! Monday March 22, 2010 9:06 Dmitri 9:08 adam feuerstein: Singer: pixantrone patients had higher cardiac related adverse events than control arm, but pixantrone patients may have had more cardiac toxicity at baseline. Monday March 22, 2010 9:08 adam feuerstein 9:09 [Comment From Aaron Aaron : ] Adam - if I compliment you will you allow my comment through or respond? Monday March 22, 2010 9:09 Aaron 9:09 adam feuerstein: Of course! There ya go! Monday March 22, 2010 9:09 adam feuerstein 9:09 [Comment From franco franco : ] what a sad disgraceful situation for all these poor people with this terrible disease. Monday March 22, 2010 9:09 franco 9:11 adam feuerstein: CTIC's Singer is getting into the weeds on the pixantrone safety data, but in summary, he is making the case with data that the drug is not adding to the cardiac toxicity of these NHL patients. Monday March 22, 2010 9:11 adam feuerstein 9:11 [Comment From usmc1979 usmc1979 : ] this blog is useless. hardly any posts from fellow posters.. it appears adam is picking and choosing the postings to favor his. Why? no clue... Monday March 22, 2010 9:11 usmc1979 9:12 adam feuerstein: I am trying to listen to the panel meeting, provide live coverage here on the blog AND monitor comments and post what I can. This isn't easy. Please be patient. I will not be posting all your comments. That's impossible. I'm getting hundreds of comments. Monday March 22, 2010 9:12 adam feuerstein 9:13 adam feuerstein: CTIC -- Dr. John Leonard from Weill Cornell Cancer Center now speaking on the favorable benefit-to-risk profile of pixantrone. Monday March 22, 2010 9:13 adam feuerstein 9:14 adam feuerstein: Leonard: These patients are toughest to treat in lymphoma. When patients get to this point, they are out of options. Survival is around 6 months. We urgently need better treatments for these patients. Monday March 22, 2010 9:14 adam feuerstein 9:15 adam feuerstein: CTIC Leonard: Very difficult to enroll a study of 3rd line NHL patients. The study achieved its primary endpoint. These responses were durable. Median PFS was 4.7 months for pixantrone vs. 2.6 months for the control group. A trend toward prolonging survival was seen. Monday March 22, 2010 9:15 adam feuerstein 9:17 adam feuerstein: CTIC Leonard: Safety is manageable and not unexpected in these patients. Low incidence of cardiac related adverse events, re-assuring in these patients since they were treated previously with anthracyclines (which causes heart toxicity.) Monday March 22, 2010 9:17 adam feuerstein 9:17 adam feuerstein: CTIC Leonard: "pixantrone provides an important benefit in the treatment of patients with relapsed or refractory aggressive NHL after 2 or more lines of therapy." Monday March 22, 2010 9:17 adam feuerstein 9:19 adam feuerstein: CTIC's CEO Bianco is wrapping up the company's presentation. "The totality of the evidence supports accelerated approval" of pixantrone. Monday March 22, 2010 9:19 adam feuerstein 9:19 [Comment From bruce bruce : ] Adam good job with the lie coverage. Please let me have my 10 seconds of fame on this blog? Thank you Monday March 22, 2010 9:19 bruce 9:19 adam feuerstein: FDA presentation up next Monday March 22, 2010 9:19 adam feuerstein 9:20 adam feuerstein: Panel members have not spoken yet at all, so no way to know what they are thinking. Monday March 22, 2010 9:20 adam feuerstein 9:22 adam feuerstein: FDA: CTIC did not seek formal guidance from agency about stopping trial early. Decision made without FDA input and considered to be violation of the study protocol. Monday March 22, 2010 9:22 adam feuerstein 9:23 adam feuerstein: FDA: For a single randomized trial to support an NDA, trial must be well designed flawlessly executed and complete, internally consistent and provide statistically persuasive efficacy. Monday March 22, 2010 9:23 adam feuerstein 9:24 adam feuerstein: FDA: Higher level of evidence is required for single trial than multiple trials, and even higher when trial is stopped prematurely and when the drug is a new molecular entity. Monday March 22, 2010 9:24 adam feuerstein 9:29 adam feuerstein: FDA : 44% of planned patient enrollment, even with planned enrollment expanded. Study was supposed to take 36 months to enroll 320 patients but after 45 months, only 140 patients enrolled. Monday March 22, 2010 9:29 adam feuerstein 9:31 adam feuerstein: FDA: Key issues: 1. pixantrone results are not robust. 2. Results are not clearly generalizable to U.S. patient population. Only 8 U.S. patients enrolled and none achieved a CR/CRu on pixantrone. Maybe CTIC should study pixantrone in combination with other drugs PRIOR to approval, says FDA. 3. Safety concerns Monday March 22, 2010 9:31 adam feuerstein 9:33 adam feuerstein: IF CTIC had planned an interim analysis of the study at 140 patients enrolled, the p value for statistical signiicance would have needed to be 0.0096. Monday March 22, 2010 9:33 adam feuerstein 9:33 adam feuerstein: In other words, FDA says study was not statistically significant. Monday March 22, 2010 9:33 adam feuerstein 9:34 adam feuerstein: CTIC's p value of 0.021 was not statistically significant, according to FDA. Monday March 22, 2010 9:34 adam feuerstein 9:36 adam feuerstein: FDA: Updated clinical data is exploratory, can't be reasonably attributed to pixantrone treatments. Some of the patients did not have aggressive NHL. Analysis was unblinded and post-hoc. not adjusted for multiple looks of the data. The updated data is exploratory only. Monday March 22, 2010 9:36 adam feuerstein 9:37 adam feuerstein: FDA: Since primary endpoint (CR/CRu) failed, it is not possible to assess or consider the secondary endpoints (ie survival) Monday March 22, 2010 9:37 adam feuerstein 9:41 adam feuerstein: FDA: The CR/CRu data is not entirely reliable: 1. Small patient numbers. Data not robust. 2. Re-review of the patient data raises concern, especially since some patients were upgrade to a CR/CRu not none were downgraded. 3. No radiologic adjudication provided, which makes data unreliable. 4. 5 of 14 (36%) of CR/CRus in pixantrone patients occured in patients with ineligible forms of NHL. Monday March 22, 2010 9:41 adam feuerstein 9:41 [Comment From Joshua-Iraq Joshua-Iraq : ] Adam, how many panel member are there for this PDAC meeting Monday March 22, 2010 9:41 Joshua-Iraq 9:42 adam feuerstein: Nine voting panel members at today's meeting. Again, we have yet to hear from any of them. Monday March 22, 2010 9:42 adam feuerstein 9:42 [Comment From jim jim : ] If the FDA is so set negative in pix, then why have this panel meeting and factory inspection at all? waste of time and money... Monday March 22, 2010 9:42 jim 9:43 [Comment From Damon Damon : ] When you say FDA... Is this the Panel? Who is the FDA... who is speaking? Monday March 22, 2010 9:43 Damon 9:43 adam feuerstein: FDA staff is presenting the agency's case on pixantrone. I didn't catch this guy's name. sorry. Monday March 22, 2010 9:43 adam feuerstein 9:43 adam feuerstein: Panel members who vote will get a chance to ask questions and offer their opinions later in the meeting. Monday March 22, 2010 9:43 adam feuerstein 9:44 [Comment From Paul Paul : ] Is CTIC done with their presentation for the day? Monday March 22, 2010 9:44 Paul 9:44 adam feuerstein: Yes, but CTIC will answer questions from the panel. Monday March 22, 2010 9:44 adam feuerstein 9:45 [Comment From Huey - Alaska Huey - Alaska : ] are they serving coffee or food? Monday March 22, 2010 9:45 Huey - Alaska 9:45 adam feuerstein: I've been to ODAC meetings in the past. FDA doesn't put out a very nice spread. The restaurant at the hotel where the meeting is held has lousy food. Monday March 22, 2010 9:45 adam feuerstein 9:46 adam feuerstein: FDA: 28 U.S. sites were open but only 8 patients enrolled. U.S. patients more heavily pre-treated but no CR/CRu. Pixantrone response in Western Europe patients also poor. Monday March 22, 2010 9:46 adam feuerstein 9:48 adam feuerstein: FDA: CTIC couldn't enroll patients because doctors prefer combination therapy in 3rd line aggressive NHL patients. This, coupled with low response of single-agent pixantrone, leads FDA to suggest that pixantrone be studied in combination with other drugs PRIOR to approval. Monday March 22, 2010 9:48 adam feuerstein 9:49 adam feuerstein: FDA: "Pixantrone has demonstrated evidence of biologic activity but the mere demonstration of biologic activity is not sufficient for drug approval." Monday March 22, 2010 9:49 adam feuerstein 9:49 adam feuerstein: That was a very damning statement from FDA. Monday March 22, 2010 9:49 adam feuerstein 9:54 adam feuerstein: FDA going over safety concerns of pixantrone now. 1. neutropenia (infections) higher in pixantrone than control. 2. Cardiac toxicity higher in pixantrone than control, including heart failure and ejection fraction (measure of heart pumping efficiency) Monday March 22, 2010 9:54 adam feuerstein 9:56 adam feuerstein: FDA conclusions on pixantrone: 1. Study was not well executed nor complete. 2. Study was inconsistent. (No U.S. responses) 3. Trial did not demonstrate statistically significant or robust findings. Monday March 22, 2010 9:56 adam feuerstein 9:56 adam feuerstein: 10 minute break, reconvening at 10:05 am. I will stick around and post some comments. Monday March 22, 2010 9:56 adam feuerstein 9:57 Monday March 22, 2010 9:57 9:58 [Comment From Teddy Germany Teddy Germany : ] Hi Adam, what is your prediction of the Panels´ vote? Monday March 22, 2010 9:58 Teddy Germany 9:59 adam feuerstein: I want to hear from the panelist's, of course, but it doesn't look good for pixantrone. The bar is set very high. Monday March 22, 2010 9:59 adam feuerstein 10:00 [Comment From timingofmtg timingofmtg : ] was this meeting the same length of others, shorter or longer than those you've been to? Monday March 22, 2010 10:00 timingofmtg 10:00 adam feuerstein: Some ODAC panels are a day long, others are half day, so it's not unusual that the pixantrone panel is a half day. Monday March 22, 2010 10:00 adam feuerstein 10:00 [Comment From vada vada : ] Adam when will voting members speak? Monday March 22, 2010 10:00 vada 10:01 adam feuerstein: The panelists should start asking questions after the break. Monday March 22, 2010 10:01 adam feuerstein 10:01 [Comment From Osama Bin-Laden Osama Bin-Laden : ] Adam you the man! come visit in Afghanistan! Monday March 22, 2010 10:01 Osama Bin-Laden 10:01 adam feuerstein: Thanks. Do you have Peet's Coffee there? Monday March 22, 2010 10:01 adam feuerstein 10:01 [Comment From fallguy fallguy : ] Adam is this kind of start and tone typical? Monday March 22, 2010 10:01 fallguy 10:03 adam feuerstein: I have seen FDA this negative and definitive in the past, which usually yields a rejection by the panel members. This is why I think pixantrone odds for a positive outcome today are low. I have seen FDA more neutral at some meetings, too. Monday March 22, 2010 10:03 adam feuerstein 10:04 [Comment From Al Al : ] Adam how many are participating in your poll? Monday March 22, 2010 10:04 Al 10:05 adam feuerstein: This live blog has about 10,000 users off and on throughout the morning. I don't know how many people are responding to the poll question. Monday March 22, 2010 10:05 adam feuerstein 10:05 [Comment From JJP JJP : ] I predict 2 in favor 7 against Monday March 22, 2010 10:05 JJP 10:05 [Comment From Sun Sun : ] Hunnn...Poor CTIC....hopes are fading...but still I can see light...because every tunnel has two bright ends...CTIC already seen some bright light before 2007 and now it will see other end of tunnel in 2010...please put this message please. Thank you. Monday March 22, 2010 10:05 Sun 10:05 [Comment From Greg Greg : ] Having Genta flashbacks. Monday March 22, 2010 10:05 Greg 10:06 [Comment From JP JP : ] Adam I don't like you but it's really cool you did this for everyone thanks! Monday March 22, 2010 10:06 JP 10:07 adam feuerstein: Panel back. questions from panelists starting. Monday March 22, 2010 10:07 adam feuerstein 10:08 adam feuerstein: I may not get the names of every panelists asking questions but i will relay the questions Monday March 22, 2010 10:08 adam feuerstein 10:09 adam feuerstein: Panel Chair asking to address why study didn't enroll fully. Dr. Leonard says docs are biased toward combination therapy. Those biases are wrong. Very difficult to treat patient population. Monday March 22, 2010 10:09 adam feuerstein 10:10 adam feuerstein: Dr. Leonard (Speaking for CTIC): I wasn't enthusiastic about pixantrone when study began but I am now based on the data. Monday March 22, 2010 10:10 adam feuerstein 10:11 [Comment From Saso Saso : ] Adam at what time the vote? Monday March 22, 2010 10:11 Saso 10:11 adam feuerstein: No set time, but should come between 11 am and noon. Monday March 22, 2010 10:11 adam feuerstein 10:14 adam feuerstein: Dr. Wilson (panel member): Asking CTIC to explain more fully if patients were really anthracycline sensitive and/or were they really refractory to the drugs used in the control arm? Monday March 22, 2010 10:14 adam feuerstein 10:17 adam feuerstein: Dr. Wilson -- questioning CTIC on the mix of patients allowed in the study. Seems like some patients should not have been enrolled b/c they had low-grade lymphoma. Monday March 22, 2010 10:17 adam feuerstein 10:18 adam feuerstein: CTIC's Bianco: Eligibility criteria based on doctor's diagnosis. Central review was supportive. Expect to have some disagreements in patient enrollment. Most patients were enrolled properly. Monday March 22, 2010 10:18 adam feuerstein 10:18 [Comment From coolhand coolhand : ] Low grade or full on NHL, what the difference if they drug help them, that just shows the advantage Monday March 22, 2010 10:18 coolhand 10:19 adam feuerstein: It matters because different drugs used for different types or stage of lymphoma. Monday March 22, 2010 10:19 adam feuerstein 10:20 adam feuerstein: CTIC Bianco -- patient responses are consistent and positive no matter how you break down the patients by the type of lymphoma. Monday March 22, 2010 10:20 adam feuerstein 10:20 [Comment From Shekhar Basu Shekhar Basu : ] very bad form politically for Jim Bianco, CEO to present,I know Ron Cohen at ACOR did a great job, but the FDA wont appreciate this Monday March 22, 2010 10:20 Shekhar Basu 10:21 adam feuerstein: It is unusual to see a CEO present at an FDA advisory panel meeting, but in this case, Bianco is a physician and a lymphoma expert. That may explain his decision to present. Monday March 22, 2010 10:21 adam feuerstein 10:24 [Comment From Jig Jig : ] Would be scary if this drug were to obtain approval from such a spotty study. Not saying Pix in particular is dangerous, but other unsafe drugs moving forward could get the nod on an equally questionable study... Monday March 22, 2010 10:24 Jig 10:24 [Comment From Chris Chris : ] Seems Bianco - being a physician - could make a pretty good argument for use of the drug as opposed to having nothing but traditional treatments for NHL patients, no? Monday March 22, 2010 10:24 Chris 10:26 adam feuerstein: Panel member asks CTIC for data on CR/CRu for patients with greater than 3 prior therapies. But CTIC doesn't have an answer for him. Monday March 22, 2010 10:26 adam feuerstein 10:27 adam feuerstein: FDA answers the question, says only one patient achieved a CR/CRu after failing more than 3 prior therapies. Monday March 22, 2010 10:27 adam feuerstein 10:28 adam feuerstein: FDA's Pazdur speaking up now, saying nothing requires a company to develop a drug in the most refractory patient population. Monday March 22, 2010 10:28 adam feuerstein 10:32 adam feuerstein: Panel member: Is it common for a company to have difficulty enrolling enough patients in a study like this? And can you explain the discrepancy between the p values claimed by CTIC and FDA? CTIC biostatistician says the study was not stopped for an interim analysis so p value threshold should be 0.05. But with accrual of only 140 patients, need to examine the robustness of the data. He says analysis of all the efficacy data is consistent in favor of pixantrone, which would not have happened if drug is not having benefit for patients. Monday March 22, 2010 10:32 adam feuerstein 10:33 [Comment From carl carl : ] Is Pazdur sticking up for CTIC or carrying a derisive tone against? Monday March 22, 2010 10:33 carl 10:33 adam feuerstein: The latter Monday March 22, 2010 10:33 adam feuerstein 10:33 [Comment From Steve Steve : ] How are you holding out Mr. feuerstein? Monday March 22, 2010 10:33 Steve 10:33 adam feuerstein: i could really use another cup of coffee. Monday March 22, 2010 10:33 adam feuerstein 10:35 [Comment From SC1404 SC1404 : ] Adam, does it seem like CTIC is unprepared Monday March 22, 2010 10:35 SC1404 10:36 adam feuerstein: Honestly, yes. CTIC doesn't seem to be as prepared as they could have been. But then, the data are the data. They can't make up stuff. Monday March 22, 2010 10:36 adam feuerstein 10:37 adam feuerstein: Panelists and CTIC discussing how patients are treated for NHL and the design of the pixantrone study. Monday March 22, 2010 10:37 adam feuerstein 10:37 [Comment From Tiscalizzato Tiscalizzato : ] Hi Adam from Italy !!!...please let me see this messages!!..HOW is the Bianco's face!!?? Monday March 22, 2010 10:37 Tiscalizzato 10:38 adam feuerstein: Glad to see we have an Italian audience today. I can't really see Bianco's face on my webcast. He's dressed well, as always. Monday March 22, 2010 10:38 adam feuerstein 10:40 [Comment From frank frank : ] are there long breaks in the questioning or are you commenting on highlights. does the CTIC panel look concerned at this point??? Monday March 22, 2010 10:40 frank 10:41 adam feuerstein: Some long breaks. Monday March 22, 2010 10:41 adam feuerstein 10:43 adam feuerstein: Panel (Dr. Wilson) Does this drug represent something new? No doubt pixantrone is active because it is part of active class of drugs. But it is unclear to me if the drug is anything new. Wilson: You haven't convinced me that pixantrone is less cardio-toxic. (My take: Dr. Wilson doesn't seem like he's a yes vote on pixantrone.) Monday March 22, 2010 10:43 adam feuerstein 10:46 adam feuerstein: CTIC Bianco: Says patients heavily pre-treated with an anthracycline but are still managing pixantrone well. (Recall, pixantrone is a new form of the anthracycline class of chemo drugs that is supposed to be less toxic to the heart. Most, if not all, the patients in this study were treated previously with doxorubicin, another anthracycline.) Monday March 22, 2010 10:46 adam feuerstein 10:47 adam feuerstein: I'm still waiting to hear from an FDA panel member who seems positive inclined toward pixantrone. Comments/questions are mostly critical, neutral at best. Monday March 22, 2010 10:47 adam feuerstein 10:48 [Comment From KKK KKK : ] Adam are you a jew? Monday March 22, 2010 10:48 KKK 10:48 adam feuerstein: Not a death threat, but getting close... Let's keep it civil, folks. Monday March 22, 2010 10:48 adam feuerstein 10:49 [Comment From lotsofluck lotsofluck : ] kkk is an idiot Monday March 22, 2010 10:49 lotsofluck 10:49 [Comment From Mahesh Mahesh : ] How many panel members are there.? how many are positive? Monday March 22, 2010 10:49 Mahesh 10:49 adam feuerstein: Nine panel members. Some have not spoken or asked questions. Monday March 22, 2010 10:49 adam feuerstein 10:49 [Comment From Mike Mike : ] Wow... that was uncalled for. Please folks, keep it civil or log off. Adam is doing everyone a favor here regardless of your personal feelings. Monday March 22, 2010 10:49 Mike 10:50 [Comment From DTA DTA : ] Are you a puppet for a short? I tried to keep it civil, you don't post my comments! Monday March 22, 2010 10:50 DTA 10:51 adam feuerstein: I have no position in CTIC -- long short or options. I am no allowed to invest in any individual stocks. I am not a puppet for anyone. LOL Monday March 22, 2010 10:51 adam feuerstein 10:52 [Comment From Berlusconi Berlusconi : ] I'm civil and i respect you, do you think that today on Nasdaq the CTIC title will re-open? Please reply to a first minister :) Monday March 22, 2010 10:52 Berlusconi 10:52 adam feuerstein: CTIC should start trading later today. I don't have a time. Monday March 22, 2010 10:52 adam feuerstein 10:53 adam feuerstein: Panel and CTIC still going back and forth over some questions about patient responses. Monday March 22, 2010 10:53 adam feuerstein 10:53 [Comment From James Riehl James Riehl : ] thank you for doing this Adam but i still don't like you. Monday March 22, 2010 10:53 James Riehl 10:54 adam feuerstein: That's okay. Thanks for reading. Monday March 22, 2010 10:54 adam feuerstein 10:55 adam feuerstein: CTIC discussing the 5 patients with CR/CRu that FDA "threw out" in its own analysis of the data. The original CR/CRu designation should remain unchanged, says an outside expert speaking on CTIC's behalf. Monday March 22, 2010 10:55 adam feuerstein 10:56 [Comment From Guest Guest : ] You may or may not like Adam, but he is doing us a great service by updating us. Monday March 22, 2010 10:56 Guest 11:00 adam feuerstein: FDA comment from Pazdur -- not here to ajudicate individual patient responses. FDA doesn't generally re- review individual patient records but did so here because there were so few patients in the study. We are using this as a check to verify the responses stated by the drug sponsor. My comment -- Pazdur (who runs the FDA's office of cancer drugs) does not want pixantrone approved. Monday March 22, 2010 11:00 adam feuerstein 11:01 adam feuerstein: Public hearing starting. This will be short testimony from patients and patient advocates. Monday March 22, 2010 11:01 adam feuerstein 11:02 [Comment From regular_joe regular_joe : ] No, your comment should be: You and the people controlling you do not want Pix approved ... and why aren't you posting my comments? Monday March 22, 2010 11:02 regular_joe 11:02 [Comment From JL JL : ] And you don't want Pix approved either! Monday March 22, 2010 11:02 JL 11:04 [Comment From Sandro Sandro : ] Adam, please report on what patients are saying.... Monday March 22, 2010 11:04 Sandro 11:05 adam feuerstein: I won't give play by play here, but the patient and patient advocates are an important part of the process. Monday March 22, 2010 11:05 adam feuerstein 11:05 adam feuerstein: Public comments done. Panel discussion starting. Monday March 22, 2010 11:05 adam feuerstein 11:05 adam feuerstein: Voting should start soon. Monday March 22, 2010 11:05 adam feuerstein 11:06 adam feuerstein: Panel chair calls pixantrone study and data "disturbing" for the reasons outlined by FDA. Monday March 22, 2010 11:06 adam feuerstein 11:07 adam feuerstein: Dr. Wilson speaking. He's been critical/skeptical of pixantrone from the beginning. Monday March 22, 2010 11:07 adam feuerstein 11:10 adam feuerstein: Another panel member (didn't catch his name) -- "the marginal significance level we see here are not demonstrating robust evidence of efficacy." Monday March 22, 2010 11:10 adam feuerstein 11:15 adam feuerstein: Panel member -- We need to appreciate the difficulty of designing a trial like this. My concern for the data is that it may not have been a fair test. Is this data reasonable to suggest that something is there? Pazdur -- Level of evidence is substantial for both accelerated and regular approval. Accelerated approval is not a salvage mechanism. My take -- this doc seemed somewhat positive for pixantrone but Pazdur came back with more critical comments. Monday March 22, 2010 11:15 adam feuerstein 11:16 [Comment From Jon Arditi Jon Arditi : ] Hi Adam, when will voting start? Monday March 22, 2010 11:16 Jon Arditi 11:16 adam feuerstein: Should be soon. Monday March 22, 2010 11:16 adam feuerstein 11:17 [Comment From Sandro Sandro : ] Who is Padzur Adam? Monday March 22, 2010 11:17 Sandro 11:17 adam feuerstein: Dr. Richard Pazdur runs the FDA's Office of Oncology Drugs. He's basically the head honcho at FDA in charge of reviewing cancer drugs. Monday March 22, 2010 11:17 adam feuerstein 11:18 [Comment From JR JR : ] Dr Pazdur Sucks! That is my professional opinion! Monday March 22, 2010 11:18 JR 11:19 [Comment From Chad Chad : ] Is Dr. Pazdur the tie breaking vote? Monday March 22, 2010 11:19 Chad 11:19 adam feuerstein: Pazdur does not vote at the panel. Monday March 22, 2010 11:19 adam feuerstein 11:19 [Comment From Razor Razor : ] How do we know that Adam is giving us a fair assessment of their statements as well their demeanor?? Monday March 22, 2010 11:19 Razor 11:19 adam feuerstein: I'm doing my best. Monday March 22, 2010 11:19 adam feuerstein 11:20 [Comment From bill bill : ] Adam sucks, that is my professional opinion. Monday March 22, 2010 11:20 bill 11:20 adam feuerstein: Oh well... Monday March 22, 2010 11:20 adam feuerstein 11:21 adam feuerstein: The panel discussion is going back and forth about access to unapproved and/or approved drugs. FDA's Pazdur making it clear that patients can get access to unapproved drugs under FDA regulations. Monday March 22, 2010 11:21 adam feuerstein 11:22 [Comment From Sandro Sandro : ] Adam u r a straight shooter. Those of us who r truly interested appreciate your efforts. Monday March 22, 2010 11:22 Sandro 11:23 adam feuerstein: Dr. Little -- in this patient population, survival is the preferred endpoint, not sure that CR/CRu tells us anything about clinical benefit. Monday March 22, 2010 11:23 adam feuerstein 11:23 adam feuerstein: Voting about to begin Monday March 22, 2010 11:23 adam feuerstein 11:24 adam feuerstein: Voting Question: Does this single, incomplete trial of pixantrone adequate to support approval? Yes 0 No 9 Monday March 22, 2010 11:24 adam feuerstein 11:25 adam feuerstein: That's it. The FDA panel has recommended against the approval of pixantrone as a treatment for aggressive NHL. Monday March 22, 2010 11:25 adam feuerstein 11:26 adam feuerstein: Panel members now discussing the reasons for their vote. Monday March 22, 2010 11:26 adam feuerstein 11:27 adam feuerstein: One panel members hopes the drug is studied further because there is evidence of efficacy. Hopes that expanded access makes drug available to patients. Monday March 22, 2010 11:27 adam feuerstein 11:28 [Comment From Steve Steve : ] You have done a great job Adam... Thanks Monday March 22, 2010 11:28 Steve 11:29 [Comment From Biancoo Biancoo : ] Adam u still suck Monday March 22, 2010 11:29 Biancoo 11:29 [Comment From Carlos Ortega Carlos Ortega : ] Gracias Senor Monday March 22, 2010 11:29 Carlos Ortega 11:29 [Comment From mark mark : ] Great Job Adam, it looks like you were right all along about CTIC. Monday March 22, 2010 11:29 mark 11:29 [Comment From mike mike : ] why the stock is not trading Monday March 22, 2010 11:29 mike 11:29 adam feuerstein: CTIC is still halted. You'll have to check the Nasdaq web site to see when trading re-opens. Monday March 22, 2010 11:29 adam feuerstein 11:31 adam feuerstein: Another panel member -- pixantrone has activity. Look forward to seeing the drug studied in combination with other drugs. Monday March 22, 2010 11:31 adam feuerstein 11:31 [Comment From Bill Bill : ] How about that photo of you with hair? Monday March 22, 2010 11:31 Bill 11:31 adam feuerstein: you mean my bar mitzvah photo? I used to have a white man's 'fro! LOL Monday March 22, 2010 11:31 adam feuerstein 11:32 adam feuerstein: Meeting is now adjourned. I won't be live blogging the afternoon session. I will stick around here for awhile to post reader comments and answer questions. Monday March 22, 2010 11:32 adam feuerstein 11:32 [Comment From Marco Marco : ] Never crazy about you but you have earned my respect Monday March 22, 2010 11:32 Marco 11:32 [Comment From Erik Erik : ] thank you for your up to date info. Adam. It has been truly helpful. Monday March 22, 2010 11:32 Erik 11:33 [Comment From BrianP BrianP : ] what happens to this company now?? Monday March 22, 2010 11:33 BrianP 11:35 adam feuerstein: A big question. I won't have time to answer fully here. Remember, FDA's approval decision date is April 23. Given the 9-0 vote against approval, i think the outcome of the FDA's final decision is clear. After that, CTIC is in trouble. The company will need cash both to run any new pixantrone studies but also for operating expenses and most importantly, to pay off the $40 million in debt coming due this summer. I'll have more on CTIC's next steps later. Obviously, it will be good to hear from the company, too. Monday March 22, 2010 11:35 adam feuerstein 11:35 [Comment From Marat Marat : ] Great Job Adam - nice to have the same level of access to ODAC as BIG SHOTS Monday March 22, 2010 11:35 Marat 11:35 [Comment From Ustun Ustun : ] Merci à Adam pour ces infos Monday March 22, 2010 11:35 Ustun 11:35 [Comment From Prat Prat : ] Dont worry about peoples comments about you . You are wonderful , Adam. Please keep it up and help us just the way u r right now Monday March 22, 2010 11:35 Prat 11:36 [Comment From Michael Jackson Michael Jackson : ] you need rogaine! Monday March 22, 2010 11:36 Michael Jackson 11:36 adam feuerstein: bald is beautiful Monday March 22, 2010 11:36 adam feuerstein 11:36 [Comment From Alan Alan : ] Great to have news in this format - real time news!. Well done Monday March 22, 2010 11:36 Alan 11:37 adam feuerstein: Thanks. This is my first time using the live blogging software. I think it worked really well. I'll definitely find ways to use it again in the future. Just to let you know, we had almost 19,000 readers to the blog at one time or another. Monday March 22, 2010 11:37 adam feuerstein 11:38 [Comment From XXX XXX : ] Now that your done, I have some shoes for you to shine. Get to work you impudent peasant. Monday March 22, 2010 11:38 XXX 11:39 [Comment From Guest Guest : ] From Sicily, Italy, thank you very much for your live comment ! Monday March 22, 2010 11:39 Guest 11:39 [Comment From BuggyFunBunny BuggyFunBunny : ] Your thoughts on 0 yes? Monday March 22, 2010 11:39 BuggyFunBunny 11:39 adam feuerstein: Brutal. Definitive. Monday March 22, 2010 11:39 adam feuerstein 11:39 [Comment From j j : ] does this mean that pix will probably not be approved next month? Monday March 22, 2010 11:39 j 11:39 adam feuerstein: Yes Monday March 22, 2010 11:39 adam feuerstein 11:42 [Comment From d d : ] In Europe is approved? why? Monday March 22, 2010 11:42 d 11:42 adam feuerstein: pixantrone is not approved in Europe. Monday March 22, 2010 11:42 adam feuerstein 11:43 [Comment From dempire dempire : ] It is adam, pixantrone is available under the EMEA regulations Monday March 22, 2010 11:43 dempire 11:44 adam feuerstein: pixantrone is available in the EU under a similar expanded access program. Monday March 22, 2010 11:44 adam feuerstein 11:49 [Comment From UCGUY UCGUY : ] Why have you been always so negative with cruel comments on CTIC! What is your problem? Even though the drug is not approved this time, no need to be so rude with your comments. What makes you so happy about the disappointment of many people who are working on this drug and have a lot of HOPE in it? Monday March 22, 2010 11:49 UCGUY 11:50 adam feuerstein: I'm focused on helping investors make the right decisions when it comes to biotech stocks. For me, that's meant steering clear of CTIC for multiple reasons. I wish every cancer drug worked. They don't. Monday March 22, 2010 11:50 adam feuerstein 11:51 [Comment From MD MD : ] Adam, is this official result ? Yes - 0, No - 9 ? Monday March 22, 2010 11:51 MD 11:51 adam feuerstein: Yes. Monday March 22, 2010 11:51 adam feuerstein 11:51 [Comment From Baxter Baxter : ] Adam, if I was there i'd buy you a coffee...good work with the live coverage. I hope you have a great day! Monday March 22, 2010 11:51 Baxter 11:51 adam feuerstein: thank you. Monday March 22, 2010 11:51 adam feuerstein 11:52 [Comment From Brandon Brandon : ] What are your thoughts on Opaxio Monday March 22, 2010 11:52 Brandon 11:53 adam feuerstein: I'm not a fan of opaxio. I've written about the drug in the past, so check our archives for my stories. Monday March 22, 2010 11:53 adam feuerstein 11:53 adam feuerstein: Remember, Opaxio has never posted positive results from a phase III study. Monday March 22, 2010 11:53 adam feuerstein 11:53 [Comment From shane shane : ] you still suck! Monday March 22, 2010 11:53 shane 11:53 [Comment From john john : ] it's the cold hard reality of facts...he just told it like it is...and he was unfortunately right Monday March 22, 2010 11:53 john 11:54 [Comment From Nick665 Nick665 : ] Adam, do you make the decision on which users' comments are posted, or is there a third party doing that? Monday March 22, 2010 11:54 Nick665 11:54 adam feuerstein: I'm in charge of posting reader comments. Trying to fairly represent all sides. Monday March 22, 2010 11:54 adam feuerstein 11:57 Monday March 22, 2010 11:57 11:57 [Comment From Johnny Johnny : ] Is there anything CTIC can do between now and April 23 for a better chance? Monday March 22, 2010 11:57 Johnny 11:58 adam feuerstein: I'm sure CTIC will discuss the panel vote with FDA, perhaps try to provide more clarification or data, but the 9-0 vote against makes it very tough to change the final outcome. Monday March 22, 2010 11:58 adam feuerstein 12:00 [Comment From Mike F. Mike F. : ] Adam, you saved me about $20,000. I did more due diligence based on your reports. I was a skeptical reader but was open to your opinion and I'm glad you reported what you did. Monday March 22, 2010 12:00 Mike F. 12:00 adam feuerstein: Thanks. Monday March 22, 2010 12:00 adam feuerstein 12:01 adam feuerstein: Interesting that 15% of you think CTIC will trade higher on this news. If you voted that way, send me a comment and I will post some. Monday March 22, 2010 12:01 adam feuerstein 12:01 [Comment From Xerox Xerox : ] I understand you want to steer and help investors, but your delivery of articles is very negative. You mention about glass half empty but there is another way of saying glass if half full!! Monday March 22, 2010 12:01 Xerox 12:02 adam feuerstein: I am a glass half empty guy by temperament. Monday March 22, 2010 12:02 adam feuerstein 12:03 [Comment From VotaPDL VotaPDL : ] Adam, you saved me about 1,000,000 Euros thanks for your information! Monday March 22, 2010 12:03 VotaPDL 12:05 [Comment From Beppe Beppe : ] Adam, I found your coverage and comments very interesting. Do you blog/write regularly? If so, where? Monday March 22, 2010 12:05 Beppe 12:05 adam feuerstein: thanks. I write daily at www.thestreet.com Monday March 22, 2010 12:05 adam feuerstein 12:05 [Comment From lob lob : ] are you a reporter or a basher? i think you belong in latter Monday March 22, 2010 12:05 lob 12:06 adam feuerstein: But being skeptical/critical of pixantrone was the right call. Monday March 22, 2010 12:06 adam feuerstein 12:06 [Comment From Malvas75 Malvas75 : ] This vote will allow NOVARTIS to buy CTIC!!! Monday March 22, 2010 12:06 Malvas75 12:06 adam feuerstein: Someone's been drinking something stronger than coffee! Monday March 22, 2010 12:06 adam feuerstein 12:07 [Comment From Ken Ken : ] Thanks Adam.....what you revealed about the breach of SPA got me out of my investment and saved me money! Monday March 22, 2010 12:07 Ken 12:07 [Comment From Obee Obee : ] Don't feel like commenting on DNDN? Monday March 22, 2010 12:07 Obee 12:07 adam feuerstein: Not here. This is CTIC's time in the spotlight. Monday March 22, 2010 12:07 adam feuerstein 12:08 [Comment From Andrew Andrew : ] Showing different points of view from readers is fine. There were a few that could have been left out. No need to post personal attacks and hurtful comments. This is not the place or forum for that and it is distracting. Thanks for your coverage today! Monday March 22, 2010 12:08 Andrew 12:09 adam feuerstein: I'm trying to have some fun AND provide valuable coverage. Not mutually exclusive. Monday March 22, 2010 12:09 adam feuerstein 12:09 [Comment From doufu doufu : ] Hi,ADAM..From China, THANX FOR UR GREAT JOB,i wonder if CTIC will perform VNDA 'S Miracle in next month. Monday March 22, 2010 12:09 doufu 12:10 [Comment From Raj Raj : ] higher on the news because pix may still be available under fda regulations. It may become takeover target since its so cheap Monday March 22, 2010 12:10 Raj 12:11 adam feuerstein: CTIC may offer pixantrone under an expanded access program, and the company may even charge for the drug, but it will only be able to recoup its costs. CTIC will not make any money from pixantrone until it is FDA approved. Monday March 22, 2010 12:11 adam feuerstein 12:11 [Comment From Nick Nick : ] I'm shocked that trading hasn't opened yet, any news as to why NASDAQ continues to wait? Monday March 22, 2010 12:11 Nick 12:12 adam feuerstein: Still no word on resumption of trading. I check here for info: http://www.nasdaqtrader.com/Trader.aspx?id=TradeHalts Monday March 22, 2010 12:12 adam feuerstein 12:14 [Comment From Monkey Lover Monkey Lover : ] You were right and I was wrong... Expensive lesson but one that I learned from! Thanks! Monday March 22, 2010 12:14 Monkey Lover 12:14 [Comment From Devin Devin : ] Any comment on not being able to trade this DURING the meeting and having to wait till it opens at 20 cents? Monday March 22, 2010 12:14 Devin 12:15 adam feuerstein: Trading halts for biotech stocks during FDA panel meetings is very common. Monday March 22, 2010 12:15 adam feuerstein 12:15 [Comment From CTICFollower CTICFollower : ] Adam, thanks for doing this! Any idea how many people tuned in to the live blogging? Monday March 22, 2010 12:15 CTICFollower 12:15 adam feuerstein: Almost 21,000 readers total Monday March 22, 2010 12:15 adam feuerstein 12:15 [Comment From Oh well. Oh well. : ] Even a bald squirrel finds and acorn once in a while. Monday March 22, 2010 12:15 Oh well. 12:16 [Comment From mikes mikes : ] i posted about how ctic will trade higher but you didnt post it? Monday March 22, 2010 12:16 mikes 12:17 adam feuerstein: From a friend, "Bald Squirrel is my new nickname." Thank you. Monday March 22, 2010 12:17 adam feuerstein 12:17 [Comment From the crow the crow : ] will this decision bankrupt the company?? Monday March 22, 2010 12:17 the crow 12:18 adam feuerstein: CTIC faces some very difficult financial decisions ahead. The company did raise a lot of money this year, but $40M in debt comes due this summer. I will focus on this question in more depth later. Monday March 22, 2010 12:18 adam feuerstein 12:22 [Comment From druggy52 druggy52 : ] Will Bianco take a pay cut to $11M? Monday March 22, 2010 12:22 druggy52 12:22 adam feuerstein: good question! Monday March 22, 2010 12:22 adam feuerstein 12:22 [Comment From lob lob : ] here's my opinion of you: i think you're a phony reporter. Monday March 22, 2010 12:22 lob 12:22 [Comment From nidaal nidaal : ] hi adam , i am from middle east , and i thank you for your job Monday March 22, 2010 12:22 nidaal 12:23 [Comment From knights knights : ] Adam I don't find that the percentage thinking the stock will trade higher is unexpected. Your audience it primarily longs. The see everything through rose colored glasses! Monday March 22, 2010 12:23 knights 12:23 [Comment From ZambianKwacha ZambianKwacha : ] You're not posting any of my posts....Do you have something against the ZambianKwacha? Monday March 22, 2010 12:23 ZambianKwacha 12:23 [Comment From ZambianKwacha ZambianKwacha : ] What type of reporting is this? Monday March 22, 2010 12:23 ZambianKwacha 12:24 adam feuerstein: pretty good, I think. But then, I'm biased. Monday March 22, 2010 12:24 adam feuerstein 12:24 [Comment From magipic magipic : ] Excellent coverage Adam. Obviously longs dont' like negative news or comments, but sometimes the truth hurts. (Yes, I'm still a long.) Just a reminder of the risks associated with biotech issues. Monday March 22, 2010 12:24 magipic 12:24 [Comment From justin justin : ] where do you get your information from, were you there? Monday March 22, 2010 12:24 justin 12:25 adam feuerstein: I was watching a live, paid webcast of the FDA panel. Monday March 22, 2010 12:25 adam feuerstein 12:25 adam feuerstein: Still no word on when CTIC opens for trading. Check here. http://www.nasdaqtrader.com/Trader.aspx?id=TradeHalts Monday March 22, 2010 12:25 adam feuerstein 12:27 [Comment From Adam Adam : ] Adam, what do you think Fair Value is for CTIC after this panel? Monday March 22, 2010 12:27 Adam 12:28 adam feuerstein: That's not me asking me a question, by the way. I'll have more details on this in a later column, but let's call it 10 cents a share, fair value. Monday March 22, 2010 12:28 adam feuerstein 12:28 [Comment From Mason Mason : ] Adam, are ya ever gonna change that default photo of you? I feel like I've been looking at that forever.. Monday March 22, 2010 12:28 Mason 12:29 adam feuerstein: It's the only known photo of me wearing a tie. Monday March 22, 2010 12:29 adam feuerstein 12:29 [Comment From Rex Rex : ] Adam, thanks for the reports and your live blog. Also thanks for ignoring all the ignorant people out there. Monday March 22, 2010 12:29 Rex 12:30 [Comment From Ugly Bald Adam Ugly Bald Adam : ] You're scum. Monday March 22, 2010 12:30 Ugly Bald Adam 12:30 [Comment From Ugly Bald Adam Ugly Bald Adam : ] Your job is a joke. Monday March 22, 2010 12:30 Ugly Bald Adam 12:30 [Comment From lob lob : ] he only posts negative comments. that's what a phony reporter do using his status to show the world only his views Monday March 22, 2010 12:30 lob 12:30 [Comment From Jason Jason : ] Thanks for the coverage Adam, everyone will have to wait until Final Decision again in April. Thanks again and have a great day! Monday March 22, 2010 12:30 Jason 12:31 [Comment From Timmer Timmer : ] We have to take our anger out on someone! Monday March 22, 2010 12:31 Timmer 12:31 adam feuerstein: I understand. And I'm here for you. Monday March 22, 2010 12:31 adam feuerstein 12:31 [Comment From Ugly Bald Adam Ugly Bald Adam : ] Thanks Adam! LOL Monday March 22, 2010 12:31 Ugly Bald Adam 12:33 [Comment From Sunny Sunny : ] Truth is Truth and Truth is bitter, and who ever represents it is hated by "others"... Way to go Adam..keep up the good work!!!! Monday March 22, 2010 12:33 Sunny 12:33 [Comment From Adam Adam : ] Should we investors expect to get anything out of the lawsuits against CTIC?? It seems that management got their multimillion dollar bonuses at our expense. Monday March 22, 2010 12:33 Adam 12:35 adam feuerstein: I've long told readers that CTIC's management team looks out for themselves at the expense of shareholders. It's always been this way. But people who invested in CTIC need to take responsibility for their own actions. Don't expect those lawsuits to provide you with any financial compensation. Monday March 22, 2010 12:35 adam feuerstein 12:38 adam feuerstein: It's time for the live blog to end. Thanks to everyone who spent a part of their Monday following the CTIC panel along with me. I hope this blog provided you with a bit more visibility into the FDA's drug review process. If you have any more questions, comments or feedback, please send me an email at email@example.com Still no word on when CTIC will open for trading, but again, check here for updates: http://www.nasdaqtrader.com/Trader.aspx?id=TradeHalts This was a blast. Thanks for reading. Bye for now.