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DewDiligence

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DewDiligence

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Re: pcrutch post# 126244

Monday, 01/09/2012 7:05:55 PM

Monday, January 09, 2012 7:05:55 PM

Post# of 253120
HSP starts US phase-3 trial for Epogen FoB:

http://finance.yahoo.com/news/Hospira-Announces-Start-U-S-prnews-2421610804.html?x=0

The program will enroll approximately 1,000 patients on hemodialysis who have already been treated with Epogen, and will take place at more than 200 different hemodialysis centers across the United States . Results are expected in 2013.

The application will presumably be submitted under the traditional BLA pathway rather than the new 351(k) pathway, and hence it has no chance to be approved as an interchangeable FoB.

This product is already on the market in Europe under the brand name, Retacrit.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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