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Biotech / Medical : Lidak Pharm. [LDAKA]
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To: James Silverman who wrote (576)9/9/1997 9:23:00 PM
From: John Zwiener   of 1115
 
James!!! Sepracor man. A slam-dunk stock.

Your questions are good. As for NDA application, Lidak has been good at keeping their publically stated schedules for prior phase whatever studies and sometimes are early. Based on their prior behavior, I tend to think that they will have the NDA filed by the end of the year.

Lidak does not claim to get FDA approval by Jan of 1998. This Bud guy apparently claims that the approval will be forthcoming by that time. I also tend to seriously doubt this. I talked to Lisa Katz in IR and she says she does not know where he is getting this info. The FDA is its own creature and will decide when it wants to.

As far as lidakol getting expedited treatment, this rumor may have gotten started by the FDA's rapid approval of the start of the new phase 3 study. Also since this drug is said to be nontoxic, the review process may go faster than some other drugs. I know that this rapid FDA approval rumor did not come from Lidak. They never promised this.

It is true that CEO Katz indicated that the stats released were worst case (as far as the FDA might look at the data, in their opinion of course). This is the way I understand what he said, but I have misinterpreted things before.

Rumors of Bristol Meyers being pleased with the results are relatively strong. We will see. Pleased to see your interest in this company.
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