I'm still concentrating on BLA contents and FDA questions. While there is always grey area and room for judgement, I'm assuming that much of that will evaporate when we see what DNDN filed and the FDA questions. This isn't like the FCC deciding on some undefined concept of decency - the more objective risk benefit concerns limit the range of sane responses ( this is why science and politics just don't mix- offense can be manipulated to suit your needs, but you can't just declare cancer cured and you have to have the courage to ask the insulting questions that may be offensive to the sponsor).
I'd be looking for "obvious" suspicious features in the raw data ( since there isn't a lot of it, these are likely to exist and may need to be explained away ), questions on analogues of PK/PD ( see post on IV http://www1.investorvillage.com/smbd.asp?mb=58&pt=m on how this can support some efficacy issues ) as they relate to the efficacy case, and general things like "what is provenge" ( is it just the antigen, if it is the product after touching patient blood what are the nominal cell populations, etc) . If they have a scatter plot of predicted vs observed survival but placebo and provenge dots aren't visually separated somewhat, I'd be a little concerned.
I'd be very concerned if I see anything that suggests they are trying to hide or obfuscate a stat issue- taxotere, model predictions, gleason, cancer-specific mortality, gross survival versus survival improvement, etc. Similarly with the science- if they discuss MOA and avoid things like overall escape mechanisms, central tolerance, tolerizing gm-csf, etc , they aren't likely to win over any skeptics. Similar concerns would apply if they need to discuss TTP in terms of variable effector or memory responses.
I'd also be encouraged to see specific plans for surveillance such as a commitment to measure prognostic factors and "provenge attributes" ( I'm thinking things like CD demographics, NK content, perhaps cytokines, etc) as well as additional antigen impurity response analysis ( what happens to your 3H uptake results if you feed DC's a blonde highlight rather than the pure antigen?).
<<How far in advance do we know who is going to be on the AC? 1 day or is it a surprise on the day of the event? Would be interesting to handicap based upon the committee members.>>
http://www.fda.gov/cber/advisory/ctgt/ctgtmembers.htm I sure don't know how far in advance it will be. I think we can predict that Mule, Chappell, Kwak, Terry, and Urba from CTGTAC will be on it, with at least Hussain from ODAC if it is to be a hybrid committee. Gunter might have some participation as a non-voting member.
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