George, I just got home from the meeting. First I will say that the way these meetings are conducted, they do not allow for a clear understanding of what is going on. I sat with Andy , whom I consider to be a very bright young man , and I don't think he will mind my saying that he was at a lost, as was I and others, as to what was really being accomplished during the so called discussion part of the meeting, the presentation parts of the meeting were well done..But during the discussion part, 18 committee members are each asked to comment on a particular question and that is the extent of the discussion ( some comment some say "ditto",some pontificate) all to often. As to these meetings, I do know that I was hearing multiple versions of what was said at both Connaughts meeting in Jan '96 and SKB's in July and now I fully understand how that can happen. You will here multiple versions of this one I am sure. I was told this was a "typical" meeting.
I just read the news release on "AOL News service" that was released late today .
In the beginning of that release is what I would now consider to be a reasonable statement as to the outcome of the meeting which is quite positive. The rest of the release covers alot of presentation points that were made in the meeting by various investigators conducting the clinical trials.
I will say that the NVX team really did a professional job in their presentation and so did the FDA.
But I must say that the FDA" Advisory Committee " is a misnomer. I don't question that each and every member may be well qualified to advise. The format however of the meeting is that they rule, dictate what is acceptable,etc. which may be fine. But if you are the "sponsor" going before this committee with out any guide lines the system is just not fair. Some Committee members made this observation of themselves today, so who knows?
Yes , I would say the meeting was quite positive. I'll add though, the Advisory Committee just isn't the final word , the FDA is.
Now , for better or worse, from my few observations today, I'd say the FDA likes NVX's vaccine. They certainly spoke up more than once in NVX's defense.
We will just have to wait and see what tomorrow brings. |
