December 20, 2012 FDA AdCom transcript is now available
http://www.fda.gov/downloads/Adviso...rugs/ArthritisAdvisoryCommittee/UCM345463.pdf
A summary by a HEB yahoo poster (kleinhopper)
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Dec 20th 2012 Adcomm transcript is up
Not sure if this has anything to do with volume and price movement today but I just noticed the transcript from the Adcomm is up. 429 pages of data mining, have at it. I am going to skip to the end to see what what actually said during the votes.
Following are some key quotes on the final vote (this is what I have been waiting for.) I listened to the Adcomm but everything happened so fast at the end that there was less clarity than what is in the transcript The bottom line is that the committee was UNANIMOUS in thinking Ampligen is likely effective in helping at least a sub-group of CFS sufferer
Dr. Hennessy (yes): “I voted yes, which suggests that I'm interested in seeing a flexible regulatory approach to this drug.”
Dr. Komaroff (no): “I think the opportunity with this drug might be substantial, and I certainly would encourage further well-designed and conducted studies.”
Dr Gardner (no): “I would like very much to see work done on the subgroup that would reduce the concern down from perhaps a million people into some appropriate subgroup that would get the benefit that would be worth the risk going forward. So I'm hopeful that the agency and the sponsor will be able to narrow the target.”
Dr Ware (no): “I'm comfortable with the way Dr. D'Agostino has summarized things.”
Dr. Dagostino (no): "when you look at the database, I think it's encouraging that there might be some efficacy."
Dr. Gualtier (no): “While I believe that there's a lot that's encouraging here and there's significant need, I'm hoping that the more careful, well-monitored study takes place, and also careful collaboration between the agency and the sponsor to do that.”
Ms. Perry (yes): “I just think my biggest concern with this vote today is, what is going to happen to those patients who need this drug? I'm disappointed by the vote”
Dr. Buckley (no): “I think -- and I think that's uniform -- that there may be a signal here of a drug that can help patients”
Dr. Russell (no): "I think we should give the sponsor
encouragement to do a very careful, well-monitored study because I think there is a signal here, and it has potential in this disorder."
Dr. Marshall (yes): "I think, as my colleagues have already indicated, there clearly is a signal here. It's probably a subgroup issue. It's not good for everyone. Ten years from now, we can still be parsing and arguing with good studies as to which subgroup it's going to work."
Dr. Unger (no): “there is something there, and I wish the data had been clearer.”
Dr. Rudorfer (yes): “I think that we have enough information in hand to make this drug available now. I think the FDA has it within its power to label it appropriately, for example, not indicated for mild illness.”
Dr. Borish (yes): I primarily just wanted to send a message that I really think there's a signal here that this drug works, and I would love to see the right study being done very quickly
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