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

To: Pancho Villa who wrote (1070)	2/25/1998 8:52:00 PM
From: WeirdPro Randy	Read Replies (1) \| Respond to of 1359

<<Some [IMO not very professional] "After the fact" arbitrary cut of the population participating in the study was needed to show statistical significance. It is not unlikely for the FDA to require more testing.>> I don't have a problem with the cutting out of the "mild stroke" portion of the study population (in which the patients don't have significant help because 95% of this patient group gets better on their own),............ in order to shed very statistical significance of the efficacy of CerAxon in the outcome of the moderate to severe patient. And the FDA can certainly require more testing, but relating to the fact that CerAxon offers something otherwise not available for a very serious and common malady, additional testing if required would likely be phase IV studies.