IMNR - Immune Response Message Board

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Biotech / Medical : IMNR - Immune Response

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To: jake burns who wrote (1247)	1/12/1999 5:49:00 PM
From: Andrew H	Read Replies (1) of 1510

That makes sense to me Jake. The prednisone obviously confounded the results, and the drug is quite likely to show efficacy once the confounding factor is removed. If it is true that those who were not using prednisone were a home run, then they should publish those results, since it would show clearly the nature of predinsone as a confounding factor if they had a decent sized non-prednisone population. I cannot imagine why they had the prednisone in there to begin with, since it is common meical knowledge that it masks symptoms. However, each trial normally takes about a year, so if they are going to do another P2 and then a P3, you are looking at perhaps another 2 years. If they are confident of the drug they could just do one large P3 and then apply on the basis of those results, and agree to do a second P3 for confirmation after approval. They could use the non-predisone P2 results to help confirm the first P3. From the current price, I cannot see an imminent buyout unless it is one of the best kept secrets in the world. I suspect the current price reflects disappointment, but not despair, with the P2 trial design and the lack of statistical significance.

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