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


To: Sam Citron who wrote (7467)12/10/2002 3:37:01 PM
From: Biomaven  Read Replies (2) | Respond to of 52153
 
A company always has the option of asking for trading to be halted the day of an AC meeting - this has been happening more frequently of late.

The transcripts are instructive not from the point of view of trading, but rather from the point of view of seeing the issues surrounding a drug as differently presented by the FDA and the company. It's a glimpse into the heart of the approval process - something which we are not normally privy to.

Peter



To: Sam Citron who wrote (7467)12/10/2002 3:38:16 PM
From: JFitnich  Read Replies (1) | Respond to of 52153
 
I'll disagree with you there. Bureaucracies take awhile to turn the ship around. Thinking at the FDA does not change overnight.

An example of this is the FDA meeting for Iressa (AZN) that took place a couple of months ago. Anyone who read through the minutes of the FDA meeting could tell that the drug had an impact on patients' lives.

By reading through the minutes for the meeting, you can also get a read on what kind of info the FDA will be looking for in the future, not just from AZN, but from OSIP, ABGX, & IMCL, all companies with similiar drugs. If you happen to be an investor in any of these companies (I own ABGX) this information is excellent for determining what types of trials and what results the FDA is going to be looking for.

I assure you, the "half-life" is longer than 5 minutes.

JF