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DewDiligence

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DewDiligence

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Re: drbio45 post# 111922

Wednesday, 01/05/2011 2:33:11 PM

Wednesday, January 05, 2011 2:33:11 PM

Post# of 257262
The shortcut is not having to prove that the Rituxan biosimilar has efficacy in NHL in a set of full-fledged phase-3 trials (plural), as would need to be done in a traditional BLA submission, but rather being able to show similar safety and efficacy to Rituxan in a less demanding phase-3 trial (singular). Moreover, phase-2 for the biosimilar can probably be eliminated altogether, so it can progress directly from phase-1 to phase-3.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
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