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

To: quidditch who wrote (10556)	2/20/2004 6:22:30 PM
From: fred hayes	Respond to of 52153

JD and Quid (Estorra): I went to the slide that JD pointed to and listened only to that. I didn't relisten to the Q&A, so I would defer to Quid wrt that part of the CC. I'll go back and relisten to the Q&A part when I get a chance. fred

To: quidditch who wrote (10556)	2/20/2004 10:28:14 PM
From: Biomaven	Read Replies (1) \| Respond to of 52153

"our opinion" that the new studies didn't confirm any tox signal or indicate other tox issues. SEPR can't speak for the FDA - all they can do is give their own opinion. Everything is toxic at some dose level - there are no absolutes here. No way a company can (or should) be more definite on this issue than they in fact were. There is always risk in any NDA. My bottom line is that this is an isomer of a very widely used drug with no dose increase. Peter

To: quidditch who wrote (10556)	2/20/2004 11:21:21 PM
From: fred hayes	Respond to of 52153

JD and Quid:(Estorra approval) >This is my single biggest concern regarding this filing< Well, I went back as promised to listen to the Q&A. The question about the tox data was one of several from the second caller, at about 25:40. The answer was hedged and included alot of hemming and hawing, but the question may account in large part for that tone. The question was whether the FDA could look at the same data and come up with a different conclusion (i.e., that there were indeed tox issues). Well, like Peter says, there is no way that SEPR could be very definitive about what the FDA might conclude, even if they knew. So I'm not bothered too much by that encounter. But in listening to the whole Q&A, I did take note of a late question that asked about the tone of recent discussions with the FDA. SEPR flat refused to answer the question, saying that they had said enough about Estorra. That made me a little uncomfortable. They could have provided a little assurance without saying too much, but they elected otherwise. Anyway, this is all just my impression, and I'm no expert on this stuff. I'm a little more worried now than I was a few hours ago, but we might be over-analyzing this thing. We'll know soon enough, I guess. fred