RespireRx Pharmaceuticals Inc (RSPI)

[gfp927z]

Brigrajac, In the presentation Dr. Lippa says -


22:05 - "There is a Phase 2 study that began early this year. We should have topline data the beginning of the 4th quarter. It's 120 subjects, 40 subjects per group.."

23:52 - "Dronabinol in Obstructive Sleep Apnea is just finishing up late Phase 2, and this is a potentially pivotal study for the FDA and could lead to an sNDA, in support of and sNDA filing."


However for Dronabinol, Slides 30 has "Top line data by Q4-2015", and Slide 33 has "Estimated completion Q4-2015"


So it's not clear which info is correct. I'll send off an email question to the company on their website and let you know what comes back.

As far as the current Phase 2b being pivotal for an sNDA filing, in the presentation Dr. Lippa said it is 'potentially' pivotal, so it probably will depend on the strength of the data. Neuro may have more insight into how the sNDA process works.