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

To: scaram(o)uche who wrote (7480)	12/11/2002 12:14:45 PM
From: rkrw	Respond to of 52153

<<Now? I believe that both parties will skirt the old Coulter issues.>> Bingo! That was my read too. <<Will sustained-release Risperdal be next?>> I would bet on it, question is when? <<And what the heck just happened with FRX??!!>> I read some interesting brokerage remarks the other day that claimed the fda wants frx to test lircanidipine 40mg once/day for moderate to severe hypertension. FRX had tried for 10mg and 20mg 1/day for mild to moderate hypertension. So the brokerage claimed the fda is pushing frx to go for an area with need rather than an improved me-too. Frx seemed none too pleased with the decision. Maybe this tough fda is handing us true bargains with resolvable issues? See SCIO for the poster boy.

To: scaram(o)uche who wrote (7480)	12/11/2002 12:16:26 PM
From: Biomaven	Read Replies (2) \| Respond to of 52153

And what the heck just happened with FRX??!! I've seen a report from Cowen (thanks, S!) that says the key issue was once-a-day dosing versus twice-a-day. The FDA was apparently prepared to approve twice-daily dosing, but the company felt that this would make the drug non-competitive. (It has once-a-day dosing everywhere else in the world). There was also a suggestion that the FDA wanted the company to explore a higher dose to treat patients who are presently refractory to existing treatment. The original NDA package apparently had little or no dose-response data, and four out of the five trials were European. ("We here at the FDA noted with dismay that none of the European trials were stratified for foie gras consumption, a well known European-specific risk factor.") Peter