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Biotech / Medical : Biotech Valuation
CRSP 56.00+8.5%Dec 3 3:59 PM EST
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To: XenaLives who wrote (3476)4/21/2001 5:47:37 PM
From: Scott H. Davis  Read Replies (1) of 52153
 
Paula, RE: RGEN - Message 15611541 I'd start there and read the rest of the posts. Essentially, problems with a PII - results actually not bad but they dorked their choice of the primary endpoint. Maybe their CEO's daughters behaved more normally outside of routine, but if he'd done much reading on the symptoms or been around many autistic children much, he should have known better - hard to get get the FDA to accept parent's evaluation (med establishment is really good at blowing us off faster than one can sneeze) but periodic visits to a clinician will almost inevitably result in a child not being seen as he/she really is - especially to the statistical confidence level required. Clinicians don't live with the differences day in/out. We do.

Sad - a very promising therapy which would have had an incredibly better help/harm ratio than the CNS effecting agents often perscribed may never get a chance at approval.

Scott (clinical analyst parent of a son with autism)
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