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Biotech / Medical : Lidak Pharm. [LDAKA]

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To: John Zwiener who wrote (12)	12/11/1996 2:00:00 AM
From: John Zwiener	of 1115

Continued from the prior page... 2)Why did you use a placebo so similar to Lidakol? A: Because topical drugs must smell , feel, look, and taste? like the drug being tested. 3) Weren't you worried about possible antiviral activity using a placebo so similar to Lidakol? A: The placebo was tested and did not originally show activity. However, because the placebo was only 60% pure (at first), they could only apply the placebo 3 times a day to nude guinea pigs?. They could not apply more than that because the impurities caused a rash that prevented accurate reading of the viral lesions. Now they have an 80% pure "placebo" that can be applied more often. Studies indicate that 3x day--no activity, 4x day--no activity, 5x day-- POSITIVE antiviral activity. 4)How did new Phase 3 studies get going so fast after an equivical result? A: There seemed to be an understanding by the FDA? that there may be a good chance that the placebo was active.

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