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Re: gfp927z post# 19902

Thursday, 08/14/2008 3:02:12 PM

Thursday, August 14, 2008 3:02:12 PM

Post# of 57939
I don't see how you can be sure of that from the June 18 PR--we do not know when the first two RD2 cohorts were finished (that's when the DSMB saw the procedural flukes) and how that lined up with RD1's enrollment completion. We know RD1 received the go ahead after RD2 and finished enrollment first--for all we know, the DSMB could have had an interim look at RD1 first. I do recall the DSMB was going to return to RD1 after thoroughly analyzing RD2, but I don't know the timing of the interim reviews-- it's possible they skipped that for RD1 because there was no 3rd dose to be chosen.

So you could be right, but I don't think we have enough information to be sure. I am still confident the data will be in better shape from RD1.

Also--they only need a few cases of successfully prevented respitatory depression, in conjunction with preserved analgesia, to be pretty sure that the latter applies. In other words, even IF some subjects had data thrown off by procedural problems, so long as a few show the desired association of RD prevention and analgesia maintenance, that's all Cortex needs.

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