RespireRx Pharmaceuticals Inc (RSPI)

[gfp927z]

No word yet from the company on the clinical hold. This past week I emailed both Dr. Lippa and the VP Jeff Margolis, and will post their response as soon as received.

In the 10-Q they say the hold is due to 'certain technical issues', so it may just be something relating to the clinical trial design (?). I mainly want to make sure there isn't another problem of the CX-717 artifact variety.

"subject to resolution of certain technical issues raised by the FDA in its recent clinical hold letter, which the Company is in the process of addressing, and which the Company expects to respond to by December 31, 2015"


http://www.sec.gov/Archives/edgar/data/849636/000149315215005352/form10-q.htm



10-Q -


>>> Anticipated Clinical Study



The Company recently filed an Investigational New Drug (“IND”) application with the FDA to conduct a double-blind, placebo-controlled, dose-ascending Phase 2A clinical trial with approximately 18 subjects to determine the ability of orally administered CX1739, the Company’s lead ampakine, to prevent the respiratory depression produced by remi-fentanyl, a strong opiate. The clinical trial will provide for the once-weekly administration of either a placebo or one of three doses of CX1739 prior to the administration of remi-fentanyl, with respiration, analgesia and a number of other clinical measures being taken after administration. Clinical supplies have been prepared, a clinical site has been selected, and a protocol has been written. The commencement of this clinical trial is subject to resolution of certain technical issues raised by the FDA in its recent clinical hold letter, which the Company is in the process of addressing, and which the Company expects to respond to by December 31, 2015. Assuming no further comments from or issues raised by the FDA, the Company expects to initiate this clinical trial during the first quarter of 2016, subject to the availability of sufficient working capital to fund this study. This clinical trial is expected to cost a total of approximately $750,000 and to take approximately four months to conduct. <<<