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Biotech / Medical : IMNR - Immune Response -- Ignore unavailable to you. Want to Upgrade?


To: Larry Brew who wrote (1245)1/12/1999 11:55:00 AM
From: Andrew H  Respond to of 1510
 
Bottom line is there was no statistical significance for the trial. The FDA will NOT recommend a drug which showed no statistical significance overall.

Now they can do a different trial with a new design and hope it will show significance--then they will have one trial without significance and hopefully one with. That will take a loooong time. If they can get a P3 with significance, that should make approval likely--however since they already have a 2B showing no significance, the FDA might want a second P3.