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Replies to #85301 on Biotech Values
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exwannabe

10/21/09 9:14 PM

#85302 RE: DewDiligence #85301

Re: PPHM, that's not quite the real problem,

That they are hyping these single arm trials is one thing.

But my problem with them is that they have been in this state for at least 3 years.

This should be simple, if the drug was really working this well they would have started a sound P2 trial to get the ball rolling.

The failure to start such trial is due to what?

Obvious answer, the data just is not what it seams.
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Robert C Jonson

10/21/09 9:42 PM

#85305 RE: DewDiligence #85301

This was yet another meaningless single-arm study where PPHM is touting the observed response rate relative to historical data.

Dew,
I understand that the preferred way to conduct these trials is with a control arm, but I don't understand why you say the results are meaningless. To me, meaningless would be a response rate that was the same as for the historical data; i.e., to treatment by docetaxel by itself. So it seems that either Bavi or the placebo effect is the cause of the better response rate, right?

I believe that Peregrine did the trials this way because it had insufficient funds to do it right. I think their hope is that these impressive results, though imperfect, are good enough to inspire a money bags BP or BB to fund more and better trials. This approach may be bearing fruit, as I can't conceive of folks like Dr. Chabner and Dr. Garnick risking their reputations by joining a loser, much less a scam, company.