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Re: None

Tuesday, 02/09/2016 2:02:40 PM

Tuesday, February 09, 2016 2:02:40 PM

Post# of 45296
In yesterday's presentation, Dr. Manuso said they are on the '30 day clock' with the FDA concerning the FDA's decision to OK the proposed CX-1739 Respiratory Depression trial. The FDA is reviewing the additional tox data they requested on CX-1739, so there should be a decision from them soon. RespireRx's complete response was submitted to the FDA on Jan 29 (per the Feb 4th press release), so figure approx late Feb/early March for a response.

In his presentation, Dr. Manuso said the additional tox data showed no signs of neuro or cardio toxicity, and the testing was done by an independent lab. So the odds of a positive decision by the FDA should be good. Just speculating here, but it might be that additional funding from the recent $2.5 mil offering could possibly be dependent upon getting the green light from the FDA (?). From Dr. Manuso's comments during the presentation, it sounds like they're ready to roll with the RD study once they get the green light from the FDA (subject to funding of course), with the study to be conducted at Duke University.

Concerning the ongoing Dronabinol Sleep Apnea Phase 2b trial (120 patients), the NIH is fully funding it and results are expected in Q3-16. Listening to Dr. Manuso, I'm starting to become more enthusiastic about this trial, not quite drinking the 'cool aid' yet, but having a later stage and possibly pivotal trial adds considerable interest to the stock.























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