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Biotech / Medical : Allos Therapeutics, Inc. (ALTH)
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To: kenhott who wrote (212)4/22/2008 11:00:51 AM
From: tuck  Read Replies (1) of 226
 
I haven't followed this closely, but . . . it sure is a good thing they have an SPA! Let's hope the FDA sticks to it. Because if there wasn't one, there is no way the FDA would go for an open label, single arm (no control?!) trial as the basis for filing. They don't say how many patients (maybe they gave a target before), though it must be at least 65.

Perhaps this'll be like Iressa . . . approved on RR but withdrawn if no survival benefit shown. I thought the FDA was trying to avoid that stuff these days; though it seemed a progressive methodology at the time (and still does).

All this said, I gather the data for PDX so far, such as it is, has been good. Have you or anyone here got any concerns about the above?

Cheers, Tuck
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