Lidak Pharm. [LDAKA] Message Board

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Biotech / Medical : Lidak Pharm. [LDAKA]

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To: James Silverman who wrote (591)	9/11/1997 1:38:00 PM
From: MCorbley	of 1115

Re: FDA Review. On the other hand, although Lidakol is not a life-saving drug, it is an easy drug to review and approve. The data are simple to interpret, the statistics are easy to follow, and assuming that the results are as expected, the effectiveness is clear-cut. There are no unexpected complications, no worrisome side effects, no interactions with other drugs, no complicated dosing regimens, no 23-page labeling requirements and no concerns over long-term toxicity. None of the patients died from "unrelated causes." There is no precarious philosophical cost-benefit analysis which will form the basis of the decision on whether or not to approve Lidakol. Life-saving drugs may get expedited review by the FDA, but the review itself is difficult and arduous. For Lidakol, the actual review process could turn out to be speedy because it is easy and straight-forward. MC

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