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Biotech / Medical : PRCS

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To: hmpa who wrote (32)6/12/2001 7:46:53 AM
From: dalroi  Read Replies (2) of 78
 
well if it was avalon then they did it again

NEW YORK (Reuters) - Amgen Inc. (NasdaqNM:AMGN - news) and Praecis Pharmaceuticals Inc. (NasdaqNM:PRCS - news) on Tuesday said they had received a letter from U.S. regulators stating that their New Drug Application for a prostate cancer treatment is ``inadequate for approval.''

The two biotech companies said in a statement that they plan to meet with the U.S. Food and Drug Administration (news - web sites) ``in an effort to clarify the various deficiencies cited in the FDA's letter, and to discuss what further steps need to be taken before the application may be approved.''

Amgen and Praecis submitted a New Drug Application for their experimental drug, called Plenaxis, for the treatment of hormonally responsive prostate cancer. The NDA was submitted in December
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