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Replies to #94479 on Biotech Values
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DewDiligence

06/14/10 7:52 AM

#97227 RE: genisi #94479

Albuferon is no-go with FDA:

http://finance.yahoo.com/news/Human-Genome-Sciences-bw-1023370671.html?x=0&.v=1

FDA has expressed concerns regarding the risk benefit assessment of ZALBIN dosed at 900-mcg every two weeks. Although the BLA review is ongoing, HGS has concluded that licensure of this dosing regimen is unlikely.

Hardly a big surprise.

In April, the Albuferon MAA was formally withdrawn (#msg-49185693), which is the typical M.O. in Europe for handling a hopeless application.