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Aiming4

08/13/08 1:35 PM

#19879 RE: gfp927z #19878

Gfp - any thoughts on when the RD1 results are likely to be released?... if I recall correctly, Roger said "a few weeks" in the webcast - which is somewhat longer than the 2 week differential between RD2 and RD1 results that we were expecting.
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neuroinv

08/13/08 2:21 PM

#19880 RE: gfp927z #19878

Gfp: Yes, your post from a few days ago about possible mask problems looks totally on the money--congratulations. The anxiety issue is also relevant, since increases in CO2 levels can trigger panic in someone who is already anxious, altering breathing patterns--indeed it is used to induce panic attacks in tests of anxiolytics. My guess is that the both the mask-fit and anxiety issues are less likely to be relevant in RD1, simply because the experimenters have done this before, which communicates some confidence to the subject (just like a phlebotomist who has trouble hitting the vein causes anxiety to escalate, someone fumbling with the mask might not inspire confidence). Also, that kind of University setting is more likely to have repeaters in the subject group ('hey guys, that nutty professor who is figuring out ways to suffocate people is offering 50 Euros for another of those tests....could be party money for Amsterdam!') who are less likely to become anxious, because they know the drill.

We do know that the DSMB would have been hyperattuned to any mask or anxiety related artifacts because of RD2, and would have flagged them--which I suspect would have been disclosable. Though my definition of material and Cortex's may not be matching up perfectly. But at least this shows that we simply have no idea whether 900mg or 1500mg works--the data was garbage to begin with.

NeuroInvestment
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enemem

08/16/08 12:04 PM

#19953 RE: gfp927z #19878

I agree with what neuro wrote about why mask-induced anxiety is not so likely to be a problem. There's another aspect: the outcome of RD-2 alerted cor to the problem, and they certainly could enquire about experiment failure rate, in light of RD-2. If the news were bad, they wouldn't wait for the analysis, since they pretty much would know the outcome based on the failure rate.

My point is that if the data were mush, they'd know already. They would have known at the time of the RD-2 results announcement.

Like everything else with cor, this isn't a binary variable: they probably have a trend to detect among those participants who didn't wash out (they could likely tolerate up to a 50% failure rate). They may have reason to believe that they have enough data for significance, so they're going ahead with the full analysis.

My hope is that they're not grasping at straws, and that their reasons for going ahead with the full analysis (and the prolonged delay) are well-founded. I think that the slow rate of progress we're seeing here is intentional. It is easy to tell people to take their time. On this view, they are slowing the process to move the announcement into September, when the news will be noticed, which, if true, reflects confidence.

I think that they will do a partnership covering all analgesia/RD indications. I think the OSA will not be part of the deal.