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Biotech / Medical : Biotech for less than a buck. -- Ignore unavailable to you. Want to Upgrade?

To: Softechie who wrote (222)	12/3/1999 2:26:00 PM
From: scaram(o)uche	Read Replies (1) \| Respond to of 743

one last note.... in the event that you've only recently started to watch the company, here's some of the old background...... In Spring 1996, the Company reported preliminary results from three Phase 3 clinical trials comparing LIDAKOL cream to a placebo cream as a treatment of recurrent oral herpes episodes. In these trials, LIDAKOL demonstrated clinical effectiveness compared to historical episode features experienced by the patients in the study, including reduced healing times, episode abortion and shortening of pain symptoms. However, similar results were obtained with the cream used as the intended placebo in the trials. If these trials had shown a statistically and clinically significant advantage of LIDAKOL versus placebo, the Company could have filed a New Drug Application ("NDA") with the U.S. Food and Drug Administration ("FDA") for marketing approval of LIDAKOL as a treatment of recurrent oral herpes. As a result of the inconclusive outcome, the Company obtained FDA approval to use an alternative placebo and to conduct additional Phase 3 clinical trials to prove the efficacy of LIDAKOL versus the alternative placebo. In July and September 1996, the Company initiated two additional Phase 3 clinical trials of LIDAKOL in the United States. The Company anticipates completion of these studies, including data availability, around the summer of 1997. If successful, these trials will complete the final requirements to file an NDA for marketing approval. If FDA approval is obtained in a timely manner thereafter, the Company believes that it is possible that commercial sales could commence sometime in 1998. See "Research and Development - LIDAKOL".