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Biotech / Medical : CVTX - CV Therapeutics, Inc. -- Ignore unavailable to you. Want to Upgrade?


To: Biomaven who wrote (111)11/3/2003 4:30:35 PM
From: A.J. Mullen  Read Replies (1) | Respond to of 411
 
Clearly there's a lot I don't know about the approval process. I thought an AC meeting was the norm. Is that not so?

I remember the company being asked about the Qt interval at H&Q in January. The response was that they expected questions to be asked, but that the prolongation was small compared to the observed range. I wasn't convinced by that; a bias that is small compared to the observed variance can still affect the expectation substantially. On the otherhand, maybe the interval between firing and recovery has little importance?

Ashley



To: Biomaven who wrote (111)11/3/2003 6:48:13 PM
From: Miljenko Zuanic  Read Replies (1) | Respond to of 411
 
Most likely.

Also, imo, the main question is not “will or will not CVTX run new trial”, it is what trial they will need to run and what are R chances for success? AC is to give FDA/CVTX guidance for this trial(s).

Approval time-frame is moved forward by at least 24 months, imo. I am expecting further decline in CVTX stock price (after AC). Good that they are moving forward with other candidates.

Miljenko