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Biotech / Medical : Lidak Pharm. [LDAKA]
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To: Red Dragon who wrote (804)1/5/1998 10:36:00 PM
From: Henry Volquardsen   of 1115
 
Red Dragon,

I wasn't suggesting that it is ok to compare the 4-5 days of healing with Lidakol to 8-10 days for untreated lesions. I was trying to deconstruct the sentence in your post that posited that if Lidakol and the placebo both showed the same results it meant that they were both ineffective. I was trying to indicate that it depended on what the results were for both compared to untreated lesions.

I agree that direct comparison could only be made as part of a clinical trial that compared Lidakol, the placebo and an untreated group. I believe the phase 3 was constructed that way but since we are all dealing with the limited information released we are all reduced to conjecture.

As far as the inclusion of people with compromised immune systems I would think that would complicate the analysis. I would think the study would be conducted on people with no other complications and the comparisons would be to similar groups.

I agree that it is very odd for the placebo to have been active. It was clearly a major blunder. But I find the explanation plausible. The design of phase 3s are done in consultation with the FDA. I can see how they would want a placebo that would be indistiguishable to all senses from Lidakol. Lidak clearly blundered in designing the placebo. Is it possible this story from company sources is a lie. Yes it is. But then you would have to consider that they are perpetrating a fraud. Dr Katz would have to be involved. Considering the size of his holdings and his very recent decision to spend his own money to increase his stake, do you think Dr Katz is involvd in fraud? I don't.

RD, I understand your position and am in the same boat and am just as concerned. But as messy as the Lidak story is, I find the only alternative explanation even harder to believe considering Dr Katz's exposure to this equity.

Henry
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