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Biotech / Medical : Lidak Pharm. [LDAKA]

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To: Henry Volquardsen who wrote (613)9/13/1997 1:24:00 AM
From: luis a. garcia   of 1115
 
Henry the FDA follows a rigorous cover their ass process to insure public safety. However it is not cast in stone. It depends on how well you make the case for your product with an eye in doing everything possible to reassure the inspectors you are not pulling a fast one.
And then Lidak is had 3 yrs of scrutiny.. so there you have it. From an FDA perspective Lidakol is been tested in Europe, in the US three major studies all show people got better faster. Hundreths of data points.. a recipe you could make peanut butter with... I mean where is the FDA's downside... On the other hand they should be a little red faced over their insistence on deactivating good product for the failed protocol... That move alone cost investors and the company dearly. And it was the FDA's insistence..at that. Then consider they use a stronger dose of it for Kaposi phase two safety trials...with again positive results.. I mean they should evaluate the data presented verify it and rubber stamp the NDA period.. One week tops,..if it was on my desk..

About blue eyed blondes Henry... they can be a lot of trouble... I don't knooow... sounds like we both need a big winner here...

luis
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