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Re: Robert C Jonson post# 147335

Saturday, 08/18/2012 6:31:45 PM

Saturday, August 18, 2012 6:31:45 PM

Post# of 257580

PPHM has done the best trials it could, and since it is cash-strapped, all the trials have been underpowered for statistical significance. Perhaps someone here can point me to similarly-sized trials in which statistical significance was achieved. If not, then the point may be (and may be valid) that since PPHM hasn't been able to attract BP/BB interest to fund high-powered trials no investors should take it seriously because no pharmaceutical/biotechnical companies appear to.



120 pts trial definitely can detect statistically significant PFS if the drug has strong anti-cancer activity. The two examples I used ARQ197 and TH302 trails had about 160 pts each. Many other similar or even smaller trials detected stat significant difference either for full population or pre-specified sub population, Roche's Metamab in 2nd line NSCLC, etc.

Trial size depends on what assumptions were before trial. Obviously PPHM assumed they could achieve statistically significant ORR and PFS, if not, why would they run a trial like that? As of cash strapped, they ran many other trials, why can't a company run one appropriately powered trial rather than tons of under powered trials if they knew the trials were under powered?

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