News Focus
News Focus
Replies to #58268 on Biotech Values
icon url

DewDiligence

01/29/08 11:31 AM

#58271 RE: DewDiligence #58268

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.
icon url

zipjet

01/29/08 1:39 PM

#58286 RE: DewDiligence #58268

>>Female hypoactive sexual desire disorder factoid:

Many of my friends claim the cause is marriage.

I wouldn't know. :-)

ij