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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: software salesperson who wrote (10860)	3/5/2004 11:37:49 AM
From: bio_kruncher	Respond to of 52153

100 patients to have received 12 months of treatment the 100 patients for 12 months and 2 trials are really 2 separate issues. There is a regulatory standard for chronically administered drugs that the minimum exposure to drug for safety purposes be 100 patients for 12 months or 300(??) for 6 months. The "2 trials" has been the generally accepted interpretation of the regulations for establishing substantial evidence of efficacy. (there are now formally expressed exceptions to this 2 trial rule).