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DewDiligence

05/11/11 3:26 PM

#119837 RE: iwfal #119836

From a practical standpoint, an SPA for a trial with an adaptive design is almost like not having an SPA at all. The whole point of an SPA is to preempt criticisms that can cause the FDA to reject an application, and an SPA for an adaptive design doesn’t really accomplish this.
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DFRAI

05/11/11 3:27 PM

#119838 RE: iwfal #119836

IWFAL - RE ONCY

I THINK they get a look at the first 80 patients. If you have time to listed to the virology interview - i did provide a link a few posts back - ceo stated that they had 30 centers recruiting and that in the next 60 days they will have 100 centers recruiting - i think that they know results from first 80 and are pushing hard to accrue the remaining patients asap, otherwise i do not see a point to mention this data about the 100 centers (if i recall correctly)

may have been a sleep, may have been a nugget of info for the careful listener

will see, nothing is sure.
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DFRAI

05/11/11 5:35 PM

#119857 RE: iwfal #119836

IWfal and Microcapfun - ONCY webcast from AGM
should be available tonight - ongoing now.

Its refreshing to hear a CEO talking about all the difficulties they had to overcome.