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nmstav

11/27/07 2:09 PM

#5131 RE: exwannabe #5116

Re Fuzzy interim goals make no sense...


"Simply put, the company and FDA have informed the DSMB that the trial should continue on at P=.011, if this is wrong ethically don't ask the DSMB to fix it."

Agree; with the understanding that the DSMB tells the FDA/Sponsor --"hey guys, your p= .025...and that now gives you two trials that beat .05. Maybe you want to sit down and discuss (the obvious ethical issues now in play)....