Friday, December 23, 2016 1:18:51 PM
So appears to be similar efficacy shown, and now it's on to Phase 3, so good news. Also good that they'll be seeking a SPA/Special Protocol Assessment from the FDA for fast track and breakthrough designations, per Dr. Lippa.
This Phase 2b was fully paid for by the NIH ($5 mil), so it'll be interesting to see if the NIH comes through again with some additional funding for the Phase 3. Hopefully having the positive Phase 2b results will help with funding in general. Having a Phase 3 program raises a bio company's status with investors considerably.
Concerning the recently re-analyzed CX-1739 Respiratory Depression results that were announced last week, there still appears to be more clarification needed. Hopefully Dr. Manuso will go into it further in the next investor presentation. I'd like to see them focus CX-1739 toward the Central Sleep Apnea indication anyway, rather than Respiratory Depression.
Well, next thing (as usual) is to find some funding. If the NIH steps up to help fund the Dronabinol Phase 3 that would be great, and hopefully this Phase 2b data will help generate some other funding interest. RSPI needs the dough, so bring on the money :o)
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