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Biotech / Medical : AMLN (DIABETES DRUGS) -- Ignore unavailable to you. Want to Upgrade?


To: jbershad who wrote (1351)5/5/1998 8:00:00 PM
From: arnie h  Read Replies (1) | Respond to of 2173
 
Just wondering if someone is going to step into the batter's box,they might want to wait until J&J puts up their final payment. If so, any arrangement might not be consummated for awhile.



To: jbershad who wrote (1351)5/14/1998 4:48:00 PM
From: Henry Niman  Read Replies (3) | Respond to of 2173
 
Dow Jones Newswires -- May 14, 1998

FDA Panel Rejects Ergo Science Ergoset For Type II Diabetes

By Otesa Middleton

WASHINGTON (Dow Jones)--A U.S. Food and Drug Administration advisory panel voted unanimously against endorsing Ergo Science Corp.'s (ERGO) Ergoset for treating Type 2 diabetes.

The committee said it needed more long-term information on the drug and encouraged the Boston biopharmaceutical company to continue its studies. The FDA rarely clears drugs not backed by its expert panels.

Panel member Dr. Jaime A. Davidson said the company didn't address important issues in its studies.

"One out of every two new patients diagnosed with diabetes are minorities," said Davidson, of the Endocrine and Diabetes Associates in Dallas. "There were very small numbers of minorities in the studies."

Dr. Robert Sherwin, acting chairman of the committee, said studies of Ergoset only showed "modest effect."

Ergo Science studied the drug in obese people with Type 2 diabetes. About 90% of people diagnosed with diabetes have the Type 2, non-insulin dependent form of the disease.

Ergo Sciences has a development and marketing agreement with Johnson and Johnson (JNJ) for Ergoset.