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enemem

08/08/08 7:04 PM

#19764 RE: neuroinv #19762

In your opinion, are the RD-2 results by themselves sufficient to initiate partnership discussions? Isn't everything pretty much on hold until the RD-1 results are in? Is our understanding of cross-species analgesia differences sufficiently advanced that Greer's data can be taken as strong predictors of the human-subjects trial outcome rather than suggestive preliminary data?

What happens if at 1500 mg there is no efficacy in blocking RD, and no analgesia? Wouldn't that mean that at the effective dose all analgesia would be lost? I don't mean to be a neurotic pain-in-the-ass here, but my concern is that the RD-2 data may not be as compelling as I think they were.

What it comes down to is the level of uncertainty surrounding analgesia preservation. My sense is that the main unknown here was the RD component, and that rat-to-human comparisons on the analgesia end of things would be more straight-forward, both because methods for testing analgesia maintenance are much more congruent in human and animal trials than the methods used to test for RD reversal, and because we know so much more about the physiology of pain, and the pharmacology of analgesics.

If this is the case, then there is considerably less riding on RD-1 than on RD-2.

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gfp927z

08/08/08 7:12 PM

#19765 RE: neuroinv #19762

Neuro, Concerning RD-1, one would assume that an interim analysis by the DSMB was done in RD-1, as it was in RD-2. The recent press release said the interim analysis was authorized by the trial protocol, so I assume that would be the case for both trials.

If there had been any procedural problems noted in RD-1 of the type seen in RD-2, wouldn't we have heard about them from Stoll, just as we heard about the delay in RD-2? (that being disclosed as part of the 6-18-08 press release).

Since there was no delay announced in RD-1 of the type that occurred with RD-2, isn't it safe to conclude that there were no procedural problems encountered in RD-1? Thanks.