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Biotech / Medical : Lidak Pharm. [LDAKA]

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To: John Zwiener who wrote (764)	1/2/1998 1:23:00 PM
From: luis a. garcia	Read Replies (2) of 1115

John/gang... I spoke with IR at Lidak this morning specifically Jeff Weinress took my call and ... I will post to the best of my recollection what we discussed... On the numbers he is kind of new and does not know what is going on with the BmY request etc.. so he doesn't know if they will be released shortly or wait for peer review publication. I explained everyone's concern regarding the numbers. On distribution. BMY has undergone two reorganizations and was caugth off guard by the swiftness of the NDA application from lidak ... their people are on holiday and their legal put out the message.. so at this time Lidak does not really know what happened there. On buying back the world contract to the rights for Lidakol ... appears to be a business decision.. better for us. On manufacture... its ready to go. TODAY. No problems making the stuff. On distribution.. we have Yamanouchi in Europe, Greeland in Japan, CTS in Israel and Boryung in Korea. all were waiting for NDA data to use in their applications for approval and distribution in their respective countries. Also some may manufacture overseas... that is a posssibility. Hence BMY excluded from World distribution... Some of the overseas distributors may obtain clearance and start ahead of the U.S. On NDA it is 150 volumes of 200 pages each... so FDA will need to review these volumes and probably will not be an overnight thing. On Lidakol... There is nothing like it out there. You can Overdose on Acyclovir and cut a day or so from your ordeal.. but at the first tingle you can reach for Lidakol and in some cases AVOID the whole episode...from what he hears and understands.. so its a very good product really timely and needed out there. FDA please move to approve this product soon as possible. luis

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