Sepracor-Looks very promising Message Board

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Biotech / Medical : Sepracor-Looks very promising

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To: quidditch who wrote (3171)	6/2/1999 11:08:00 PM
From: John Metcalf	of 10280

Having read both of Ms. Hankin's warning letters, I can say that she did not entirely repeat herself in the second letter. Some of her concerns seem, to me, to be purely semantic -- she has objected to use of the word "pure" even though "optically-pure" appears in Sepracor's patent title for levalbuterol. Ms. Hankin seems to insist that they can't refer to Xopenex as "pure" because that connotes that other products are chemically impure. Her basic objections are items like use of the word "children" without saying "children over 12 years" as on the approved labeling; failure to give prominence to side effects and prescribing precautions; and insistence that the S-isomer has not been clearly shown to be non-beneficial or harmful. She seemed to be stridently objecting to any sales material that imputes advantage to the product and insisting on repetition (in advertising!) of exact FDA language. Hail, brave new world -:)

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