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Biotech / Medical : Lidak Pharm. [LDAKA]

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To: luis a. garcia who wrote (378)8/15/1997 1:50:00 PM
From: MCorbley   of 1115
 
Luis, I agree with you completely that Lidakol has been shown to be effective in previous studies, both clinical and pre-clinical. And I agree that they passed the 0.05 level for statistical significance. However, I really expected a higher level of confidence in such a large study.
Moreover, it wouldn't be that hard to give the actual mean healing times, at least for the overall data. That's only two numbers, which should be somewhere around 7 days for the placebo group and 2.5-5 days for the experimental group based on earlier studies.
Also, I am dubious about the FDA granting approval "within a few days" of an NDA for any drug.
Michael
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