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Biotech / Medical : Sepracor-Looks very promising

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To: Biomaven who wrote (2380)4/16/1999 3:38:00 PM
From: quidditch  Read Replies (1) of 10280
 
Peter: Thanks for the DD. I am an SEC practitioner and know nothing of the custom and practice inside the FDA. Absent a closing of the positions of the agency and SEPR through correspondence invited (demanded) by the examiner, will the existence of this letter and the (according to the FDA's perspective) unwarranted, aggressive posture taken by the Company influence the course of future approvals/labeling discussions?
Reading the letter naked, without the results from the trial (except as included in the examiner's letter), it would seem that SEPR took some liberties based on a "fair" read of results. For SEPR's initial independently developed and marketed drug, I wonder if management will rethink its orientation. Regards. Liacos_samui
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