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Biotech / Medical : Sepracor-Looks very promising -- Ignore unavailable to you. Want to Upgrade?

To: Don Miller who wrote (3164)	6/2/1999 4:32:00 PM
From: RCMac	Read Replies (1) \| Respond to of 10280

Recall that in April there was another FDA "warning letter" of some sort concerning SEPR's claims for Xopenex, discussed at length on this thread starting at post 2380 (through about #2416, and again at 2463-64]. Here is Peter Suzman's #2380, with a link to the April FDA letter: techstocks.com --RCM

To: Don Miller who wrote (3164)	6/2/1999 4:41:00 PM
From: Bob Swift	Read Replies (1) \| Respond to of 10280

Even though Xopenex is better and the data support the hypothesis that the S isomer has problem, it is nonetheless a hypothesis which needs to be proved conclusively by further experiments (e.g. feed people with S isomer and watch them get sick or collect statistical data over long period of time to show how bad albuterol is compare to Xopenex). Of all people, the CEO (as a scientist) knows that but SEPR is still not skillful in writing around the concerns of the FDA which goes by the book. One way to do this is to write the promotional material twice. First write it as the scientific data allow (limit) and then rewrite it to bring out the hypothesis. It really is not that difficult to write in such a way so both SEPR and the FDA win. SEPR management needs to wake up and hire someone to do the careful writing of promotional material. There will be ICE that are black and white and there will be gray ones and this problem will not go away. Let the writing be conservative but leave room in writing for the sales to expand on orally. The market is fighting the FED today, I don't like that.