Dendreon Corp fka DNDNQ

[nerdseeksblonde]

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?).