The actual transcript of November 15th meeting is posted on fda.gov., all 177 pages of it,at page 170 the members who voted NO are asked to explain their reason. The first guy says he wanted a larger trial size of 8-10,000 patients, read how each one 'agrees' with whatever was said before them before adding their own comment(if any). Including the NO's who seemingly favored approval for the higher risk patients, to lessen safety issue. The very last comment came from Dr Gellin ,from CDC, IMO another 'SOFT'(see p.168) NO vote , I'm now quoting Gellin "we have to be realistic that if you double or triple the number in the trial you are STILL looking for rare things to happen, and they are unlikely to light up if you have a study population of eight, 10, 15 thousand, if you are looking for one in a million...........as we start looking at these new adjuvants there is going to be a lot of scrutiny about that experience. So that doesn't mean that we need to go slowly, but we need to go methodically." Reading that transcript, I found a lot more reasons in to believe.............in approval.
ADCOM complained about theoretical autoimmune disease that weren't even supported by the data. This is the FDA quote from the Briefing DOCS
"The safety profile of HEPLISAV was similar to Engerix-B. Despite enhanced safety
surveillance for autoimmunity, there was no observed increase in the occurrence of local and
systemic post injections, new onset autoimmune disease, exacerbation of pre-existing
autoimmune disease, or induction of autoantibodies in HEPLISAV recipients over that observed
in Engerix-B recipients. "
the "FIX" was in for sure,i am positive. the chairman was the only one that voted no to Question #1. he steered that whole circus. the day before he was voting all positive on Glaxco drug. coincidence? i dont think so.JMHO
gb, page 158, Daum states " and FDA statement that they haven't finished analyzing the data yet and so I don't think it is time to say that something is adequate or not adequate based on that. So that is my reason for voting no. " He CAN'T decide, adequate or not adequate. He doesn't know that he can "ABSTAIN"? What a joke.
Anyone know why there was 1 abstention on the panel? Was it a conflict? What if the safety vote was 8-6?
I think that the FDA has more than enough cover to grant full approval for Heplisav, however politics being what they are, and government employees being what they are, I learned never underestimate the power of government to do the wrong thing.
soup, The STRANGEST 'NO' vote was made by Nate Brady, the panel's "CONSUMER REPRESENTATIVE" . Has anyone EVER seen the consumer 'advocate' vote no? I have never seen that happen. In my experience, EVERY expert that attempts to handicap the potential outcome of the final vote has always regarded that one as an automatic 'yes' when it comes to a NEW drug like Hepislav.
Consider this. What if Daum had instead been as vocal & influential on the positive side as he was on the negative side. Vote likely would have been 14-0 and maybe something like 12-1.
While I don't give credence to him being a GSK hired hand, on the other hand it's very interesting that he singlehandedly caused a shift in 10s of million of dollars.
Assuming Heplisav nevertheless gets an approval, some investors/traders presumably will have made millions due to Daum.