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


To: Biomaven who wrote (194)8/30/1999 11:06:00 AM
From: Vector1  Read Replies (1) | Respond to of 427
 
Peter,
I am so pissed I can barely type. Fortunately I have a busy day at the office and don't have time to focus on this. The modifications are so minor it is ridiculous.
V1



To: Biomaven who wrote (194)8/30/1999 3:41:00 PM
From: RWReeves  Read Replies (1) | Respond to of 427
 
It, could be that Avalon had already covered by this time and got spanked with the rest of us. In any case, just shows the volatility of the market that a stock loses a third of it's value on a non-event like this. I can't say for certain, but it sounds pretty minor- I've had similar types of discussions with the FDA and resolved them in a single phone conference with no loss of stride.

I do know what the agency is asking for at the moment in MAB therapeutics. Some of it is a little unusual- CBER is very concerned about a couple of special areas and is routinely asking for more information in a couple of areas-(mainly the documentation of animal origin and history of cell lines because of TSE's, and an unusually keen interest in HAMA responses in the clinicals). IF (big IF) that's all it is, should not be a big deal.

Press release didn't sound like a big deal- As long as you don't need to go back to the clinics or re-do manufacturing studies should be a quick turn.

My continued estimation is that CBER WANTS to approve Bexxar for internal reasons, but that with any new drug or biologic that safety comes first.

My stop got creamed with everybody else but I've been nibbling back in. Imagine if this happened to the DOW. Amazing.

RWR