Biomatrix (BXM) Looking Great Message Board

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Biotech / Medical : Biomatrix (BXM) Looking Great

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To: Andy Wall who wrote ()	11/20/1996 10:43:00 PM
From: L. Remmel	of 569

FDA hearing today was interesting: the studies presented based on German tests showed great data and efficacy. The US study, done before the German, had been unblinded in week 4. The efficacy during first four weeks was not statistically significant, except for a subset of the patient population. The German studies showed increasing efficacy over the first few weeks, then fairly level to week 24; i.e., the US and German studies were not really incompatible, the US study was, in retrospect, not well designed. There should have been a longer control period. 7-2 vote for proposing approval. One of votes against voted against as the proposed approval was "too constraining for the company". I thought, all in all, it was a great day for the company - LR

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