tag:blogger.com,1999:blog-4241416962008169508.post5346285838143340195..comments2024-03-29T10:23:47.050-04:00Comments on Just A Life Sciences Blog...: InVivo Blog's "Deals" Column Nails The Saphris® SituationUnknownnoreply@blogger.comBlogger2125tag:blogger.com,1999:blog-4241416962008169508.post-78934447026388968602010-10-19T12:24:00.474-04:002010-10-19T12:24:00.474-04:00Indeed. I completely agree.
NamasteIndeed. I completely agree.<br /><br />NamasteCondorhttp://shearlingsplowed.blogspot.comnoreply@blogger.comtag:blogger.com,1999:blog-4241416962008169508.post-45430928364731416552010-10-17T18:14:40.807-04:002010-10-17T18:14:40.807-04:00"Making matters trickier in the EU, the schiz..."Making matters trickier in the EU, the schizophrenia indication was turned down in there because regulators were not convinced of the agent's clinical effectiveness. . ."<br /><br />This is not new information and has been discussed here many times.<br /><br />Both the FDA clinical pharmacologist and the FDA statistician both said that there was not adequate evidence of efficacy for the schizophrenia indication. The clinical pharmacologist because the study was a 'failed study' as the positive control did not work and noncomparable patient populations, and the statistician because the same study wasn't adequately powered. (This was also reiterated by the Advisory Committee Statistician.).<br /><br />Remember you heard it here first (15 months ago).<br /><br />This of course does not even cover the problems with efficacy in bipolar (see Tuesday past and other SGP posts).<br /><br />SalmonAnonymousnoreply@blogger.com