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Biotech / Medical : Lidak Pharm. [LDAKA]

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To: James Silverman who wrote (587)	9/10/1997 2:25:00 PM
From: Henry Volquardsen	of 1115

James, I don't subscribe to Bud's newsletter so I am not sure what he has said. As I may have said earlier, I agree that a Jan 98 NDA is probably wishful thinking. FWIW I think you are too pessimistic about the timing. My reasons are as follow. When Lidak released the phase III results they stated that they had already begun the paperwork for the NDA in advance of completing the trails and planned on presenting the application by year end. Lidak has been pretty good on keeping with dates so I suspect a December target for the application is doable. I hear your comments regarding the FDA's potential to slow down the process. We are dealing with a beauracracy after all. But Lidak has demonstarted some ability to work well with the FDA in the past as they were able to proceed with the second phase III fairly quickly. Also Lidakol has been shown to be non mutagenic so the review should be pretty straight forward. My admittedly optimistic guess is that the review takes 6 months but I wouldn't be shocked if it took a year, I'll stick with late spring 98 for purposes of bragging rights:). Your outlook of mid 99 strikes me as to pessimistic. In any case I am long Lidak, will stay so and probably continue to accumulate.

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