Sepracor-Looks very promising Message Board

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Biotech / Medical : Sepracor-Looks very promising

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To: Don Miller who wrote (3180)	6/3/1999 11:55:00 AM
From: Biomaven	Read Replies (2) of 10280

Don, Yes, these letters are common, and getting more so. Don't know how they are usually resolved - negotiation I suppose. They are quite different from warning letters, which are much more significant. I don't recall the news wires reporting on one before except for examples involving TV advertising. (With a healthy short position, I'm afraid you have to expect that publicity like this will occur). They've been available on the web at the FDA site for at least a year or so. fda.gov This shows the SEPR letter was posted on 6/1. Description of warning letters: fda.gov Encouraging post on YC about the MS meeting: Lind of MS met with company Jim_pd Jun 3 1999 10:17AM EDT 1.Company comfortable with 37 million Xopenex sales for 99 and 167 million for 2000(up from about 94.3 million last update).800-1000 patient trial assessing lung function may be available 3rd qtr.If shows statistically significant improvement in lung function and racemic actually decreases lung function implication could be huge. 2.FTC issue not a problem 3.LLY will start 2 500 patient trials on prozac 11 in August which could be pivatal and be completed in mid 2000. 3.FDA letters-very common.Start high and come down.Very common but ususally not published on wires. Peter

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