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nuke661

07/29/12 7:41 PM

#85341 RE: entdoc #85320

Entdoc, the one important data poin they are flaunting is already published and its associated with the most important trial end point, OS. As expressed by MOS for the trial. For both front and 2nd line they have publicaly stated that MOS has not yet been triggered for either front line or 2nd line trials. To me, this clearly says they are better than anything out there previously tested for 2nd line NSCLC based on all the other trial data for NSCLC presented in the information that I have researched or has been posted on this board.

Worse case values can not be less than 9.5 months (conservatively estimated based on completion of enrollment dates). Per FDA records, Docetaxel (current SOC for 2nd line) trial MOS was 7.5. I know the trial participant numbers are different, but it is a randomized, double-blind placebo controlled trial vs standard of care and the FDA does look at compelling data for low unmet medical needs produced using acceptable trial formats. And no format is more acceptable than the one PPHM used (as far as I can determine).

That's why I'm saying they are flaunting data. Not reaching an endpoint to me is just as relevant and maybe more relevant in this case than reaching it.

Please keep me grounded if I'm using false logic or jumping way ahead. I appreciate any critiquing on the subject matter.

Thanks Entdoc.