Biotech Values

[Robert C Jonson]

PPHM gave out primary endpoint ORR and secondary endpoint PFS numbers without stating whether they are statistically significant or not. Obviously there are people who are dumb enough to believe they are or don't know the difference. PPHM then artifully shifted the discussion to MOS. Whether this is intentionally is in the eyes of beholders.


I know this is a big deal to everybody on this board, and maybe justifies skepticism, if not cynicism about anything PPHM.

My observation, and question if you will, is that 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.

I think the long-term investors who post on the PPHM board concede the statistical insignificance of our trials, but cling to the belief that the results we're getting are clinically significant and will be borne out statistically once we persuade the money partners to pay for the requisite phIII. I also wonder if our OS results could be so compelling as to obviate the lack of p values and stat. sig. HR for this underpowered trial.

BTW, the reason our posters are referring this to a gold standard trial is because (we feel) is structured the way our phIII trial will be structured if it comes to that. Perhaps there's a better term for a trial like this than "gold standard."