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To: axial who wrote (8531)1/27/2002 11:42:29 PM
From: DaveAu  Read Replies (2) | Respond to of 14101
 
Jim,

These terms phase 1, 2, and 3 are a little misleading. The WF10 "phase 2" trials involved a very small number of patients. There is absolutely no possibility of any drug being approved by the FDA on the basis of such small trials.

One example I'm familiar with is AXO. They just announced mixed results of their phase "2b" trial in cancer. Having been granted FDA fast track, they intended to file for FDA approval after this trial but note that the 2b trial enrolled 350 patients (far more than the WF10 phase 3) and they also had several other phase 2 trials which put them over 500 patients that actually received the drug as opposed to the placebo.

While I'm thinking of AXO: they had a delay in announcing the results and it turned out that it was due to how crummy their results were. They needed time to try to put a positive spin on it. Is DMX/Oxo now doing the same thing with WF10 ? It shouldn't take this long.

Dave



To: axial who wrote (8531)1/28/2002 12:52:22 AM
From: padco  Respond to of 14101
 
Jim, with regard to the Orphan Drug Act, here's a site with some related links...........

cptech.org