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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?


To: XenaLives who wrote (3476)4/20/2001 11:22:08 AM
From: Biomaven  Read Replies (3) | Respond to of 52153
 
Paula,

I haven't been following RGEN of late, but the GNLB moves were more than just bad journalism. The FDA briefing posted ahead of the Advisory Committee meeting was very negative, and not surprisingly the stock plunged. The AC meeting itself was more positive than could have reasonably been predicted based on the FDA briefing, and hence the recovery. Thus to my mind the GNLB moves have all been rational.

I'd be very cautious holding GNLB for long. With the FDA in its present mood I doubt they will jump to approve.

Peter



To: XenaLives who wrote (3476)4/21/2001 5:47:37 PM
From: Scott H. Davis  Read Replies (1) | Respond to 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)