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Biotech / Medical : Paracelsian Inc (PRLN)

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To: Hank who wrote (2956)	7/7/1997 9:01:00 PM
From: Michael Yang	of 4342

Over the week end, I read an interesting news article about some guidelines that are drafted by FDA in regard to chinese herbal medicines. These guidelines will determine an herb as drug if the herb (or a mixture of herbs) has been shown efficacies in clinical trials. The biggest breakthrough is that the companies applying for the approval need not to identify the exact component that is effective, meaning that one of the biggest hurdle preventing herbal medicine to enter the clinical trials to be removed. Further more, herbal medicine need not to be marketed as dietary (or nutritional) supplement but really as drugs as long as the efficacies are shown, thus becoming main stream drugs. This certainly explains why FDA wanted to regulate the PRLN's two products. The new guidelines certainly would greatly ease the PRLN's pain in finding partners. I was going to call PRLN today to confirm this but was too busy to do so. The news article also said the guidelines could be published as soon as by the end of the year. The news article also said there are about 10 applications for herbal medicine that are pending at FDA, and most of the applications are sponsored by Japanese drug companies.

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