Biotech vs. Shorts Message Board

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Biotech / Medical : Biotech vs. Shorts

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To: RWReeves who wrote (192)	8/30/1999 9:53:00 AM
From: Biomaven	Read Replies (2) of 427

Score one for Avalon: FDA has requested modifications to the Biologics License Application (BLA) for Bexxar(TM) (tositumomab, iodine I 131 tositumomab) submitted for marketing approval for the treatment of relapsed or refractory low-grade or transformed low-grade B-cell non-Hodgkin's lymphoma. In written communication to Coulter, the FDA's requests principally involved reformatting of certain sections and additional analyses of existing data in the BLA. No additional trials were requested nor did the FDA require new information from ongoing trials or on manufacturing. Sounds like it is easily fixable, but still enough to send the stock down sharply today and to shake some confidence in CLTR. Peter

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