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Biotech / Medical : VD's Model Portfolio & Discussion Thread -- Ignore unavailable to you. Want to Upgrade?

To: Arthur Radley who wrote (8874)	7/25/2001 11:06:37 AM
From: Arthur Radley	Respond to of 9719

If this news report is true, AMLN must have some of the dumbest scientist in the world to submit this drug for approval. If true, such actions by AMLN, will only hurt other drug companies in the future as this will make the review process go under a bigger microscope(IMO). FDA says Amylin's Symlin effectiveness "trivial" NEW YORK, July 25 (Reuters) - Federal regulators, in a preliminary review of Amylin Pharmaceuticals Inc.'s (NasdaqNM:AMLN - news) experimental diabetes drug Symlin, said the drug's effectiveness was ``trivial'' and said the drug trials violated good medical practice. In a summary review by the U.S. Food and Drug Administration's division of metabolic and endocrine drug products, which was posted on the FDA's Web site, the FDA said trials of the drug violated good medical practice, that the drug's effectiveness was ``trivial'' and that any benefit from the drug is far outweighed by its risks. The FDA said in the document that ``pramlintide reduces postprandial hyperglycemia during the first few weeks of treatment, but the long-term reduction in HbA1c is trivial and is completely overshadowed by the risk of severe hypoglycemia.'' Pramlintide is the active ingredient in Symlin. The agency went on to say that: ``Particularly alarming is the number of patients that had life-altering events on pramlintide related to hypoglycemia. The trials deviated so much from good medical practice that they provide little insight into which patients would benefit from pramlintide or how pramlintide should be used.'' In a statement issued this morning, Amylin said: "While there is always uncertainty regarding the outcome of the FDA's review of a new drug candidate, the company believes that the results of the Symlin clinical trials are compelling and support regulatory approval of Symlin