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Biotech / Medical : Lidak Pharm. [LDAKA]
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To: James Silverman who wrote (573)9/9/1997 8:27:00 AM
From: Henry Volquardsen   of 1115
 
James,
I agree that Jan 98 may be optimistic. However the company apparently is pretty close to filing the NDA. There has been talk that the FDA realizes that their demands regarding the placebo were part of the problem with the origional phase III trials and have indicated that they will expedite the review. This may be just hot air but I am relating it to give you part of the background some people are using. More significantly Lidakol has been shown to be non-mutagenic which should aid in the review process. Whether or not the rumours re the FDA are true the review process should not be overly lengthy. Once the approval is in place the manufacturing capability and marketing are already lined up through various licenses. My operating assumption on Lidak is that by this time next year they will have a product on the market.

Re your side note. I had some concern re the wording of the Phase III results as well, particularly the lack of details re the amount of the reduction in healing time. The company insists that this was done in order to be able to release this information in professional journals. They apparently want to be very certain to make sure the compound has professional acceptance. When the market responded in a lackluster fashion Dr Katz released a public statement expressing surprise at the stock action and ststing there were significant reductions in healing time. While I eagerly await the release to the journals of specific numbers, this statement makes me believe the reduction in healing time is similar to the two to three day reduction indicated in the origional trial.
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