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Biotech / Medical : Alseres Pharmaceuticals -- Ignore unavailable to you. Want to Upgrade?

To: GREATMOOD who wrote (543)	1/21/1998 8:35:00 AM
From: Dr. John M. de Castro	Read Replies (1) \| Respond to of 975

These data look strong. Combined with the data from the prior therafectin trials, this could make a pretty good case for approval. In general, the FDA frowns upon after the fact analyses and meta-analyses as BLSI is planning. They like to see the primary endpoint statistically significant within the single trial. BLSI's therafectin trial failed to do this. The primary endpoint was not significant. So, they will have an uphill fight with the FDA to get Therafectin approved. On BLSI's side are the nice outcomes outlined in the release. They are correct in pointing out that the measures they are now employing are the ones that are typically used in RA trials. The safety data on therafectin is also a plus. I'd give them a 50-50 chance for approval. I'd appreciate hearing the opinions and reasoning of others on the likelihood of approval. John de C