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DewDiligence

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DewDiligence

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Re: DewDiligence post# 58268

Tuesday, 01/29/2008 11:31:45 AM

Tuesday, January 29, 2008 11:31:45 AM

Post# of 257259
An SPA can be obtained after a phase-3 trial starts, despite the FDA’s regs to the contrary. BPAX has done this with LibiGel.

The workaround is that patients enrolled prior to the SPA’s issuance are not counted in the statistical analysis plan.

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

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