Friday, August 19, 2016 5:20:39 PM
https://clinicaltrials.gov/ct2/show/NCT01755091?term=dronabinol+sleep+apnea&rank=1
In the investor presentations I remember Dr. Manuso saying that this study might potentially be pivotal and sufficient to file for FDA approval, assuming strong enough results. Dronabinol is already approved for other indications (AIDS anorexia and CINV/chemo induced nausea and vomiting), so the bar should be lower for approval for an additional indication like sleep apnea. With only 78 patients, whether this trial will be enough is a good question, obviously 120 would have been better.
Fwiw I'm more interested in the Ampakine side, though success with Dronabinol would be nice since it's further along clinically.
Still no update or SEC filing concerning the result of the R/S shareholder vote or timeline for when the R/S will go into effect. I'm figuring the CX-1739 RD results will be released to roughly coincide with the R/S, and hopefully there will be news on raising some money. These micro bio stocks are always full of surprises though, and these days I just follow them for fun and keep access to my wallet off limits :o)
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