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Biotech / Medical : Human Genome Sciences, Inc. (HGSI)
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To: tom pope who wrote (1116)11/16/2009 7:25:51 AM
From: tom pope   of 1127
 
Shouldn't have cut it off where I did.

“We have responded to all of FDA’s previous questions. We plan to address the current questions as well,” said Sally D. Bolmer, Ph.D., R.A.C, Senior Vice President, Development and Regulatory Affairs, HGS. “In certain respects, the Complete Response Letter appears to be inconsistent with the FDA’s published final rule governing the development of new drugs when human efficacy studies are not ethical or feasible.”
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