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nmstav

06/22/07 12:33 AM

#4355 RE: rancherho #4352

“The nature and timing of any post Provenge therapy for 9902b patients between ITT and placebo patients may have a substantial impact on survival statistics, especially in the case of sicker patients where quicker and more dramatic rescue is vital…

….the relative impact of follow-up therapies (Taxotere, other taxanes, CTLA-4 blockers, etc.) may have unpredictable impacts that extrapolation of statistical results from the 9901 and 9902a trials to projected 9902b results may not account for.”


Provenge, as you note, overcame crossovers in 9901/02a …are you suggesting that if there are no controls on the use of all the new combination therapies…9902b is then just a crap shoot? And while “unpredictable” –the impacts are more likely to be negative regarding any interim look? What about final analysis?

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Platina

06/22/07 3:10 AM

#4362 RE: rancherho #4352

rancherho - Tks for a comprehensive reply, and it proves that I don't have the necessary competance even to be on this board. I put my trust into people like you on the IV board and the AC conclusions Re the science when investing in DNDN.

I'm holding my shares for now.

My competence is within Maritime Biz and Offshore Rigs/Drillships & FPSO's, anything afloat so to speak. So should you need any advice on this front I'm at your service.

Again tks for reply, highly appreciated.

Best regards,
Morten, Oslo, Norway
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nerdseeksblonde

06/23/07 8:46 AM

#4386 RE: rancherho #4352

We agree on many of these points,
but please see some of my other posts
specifically those supporting the FDA decision.

DNDN needed management that understands the importance
of details- maybe their CEO doesn't need to
know what TOF-MALDI-MS stands for but someone who
can appreciated that small things could matter
could be a big plus ( the lack of an in vivo target
is a big deal- either they aren't looking properly
and it really does generate PAP responses [ not
out of the questions ] or it uses a different mechanism
[ including attack on conformational epitope- note
that blonde highlights change shape ] or it
doesn't work [ which they may even be able to prove in vitro]).
I think in one recent CC someone even asked about antigen lifetime and Gold or Urdal quoted a "shelf life" as if
it were somekind of known number like the speeed of
light. Since they don't know how it works and there is
some literature suggesting that immunological properties
change during storage, you would think they would have someone actually looking at this.

Simply relegating their only science- cd54- to a legal role when the efficacy was so questionable was a big blunder. The way Urdal was talking it was "clinically meaningful" or words to the effect that it meant something to patients.

Does anyone know if Gold is showing that cartoon at investor presentations? You would think he would be highlighting the
problems ( opportunities ) and explaining how they are attacking them to create real value ( patents that lead to optimized products and spark the interest of potential collaborators that don't want to make a career out of cartoon MOA's).