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Biotech / Medical : Lidak Pharm. [LDAKA]

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To: Red Dragon who wrote (616)9/12/1997 3:50:00 PM
From: Henry Volquardsen   of 1115
 
Actually Red Dragon they have patented the placebo. The explanation that I heard was that in order for the patients to be unable to tell the difference between Lidakol and the placebo they had to be very similar. This was the subject of much discussion with the FDA and was done as per the FDA's directive. The preperation that was designed by Lidak to appear to be Lidakol while being active was prepared and tested by a third party, I believe one of the licensees, and test as inactive. Lidak then prepared that formula for use in the Phase III trials and used them. When the phase III showed the placebo to equal Lidakol further investigation was done. It appears the placebo was incorrectly prepared when tested for activity. When Lidakol prepared the placebo correctly it turned out to be active. Obviously there are numerous questions raised by this explanation and can be interpetted both positively and negatively. I offer it as more info.

Both you and James point out something I consider key. The Placebo effect in testing, which as James says is particularly germane when considering a condition like oral herpes. It is very important to see what the difference in healing time between Lidakol and the placebo are. I anxiously await the publication of this data.

BTW I am sorry to contradict you on this but the negative price action in 94 was a direct result of the Dan Dorfman comments. I've gone back and retrieved all the 94 announcements via Bloomberg and the phase II results were positive. The wording pertaining to the comparison with the placebo was "substanially reduced...compared to placebo treated patients". The numbers based on different analytical categories ranged between 25% and 50% reduction in healing time.
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