Saturday, November 21, 2015 12:53:54 PM
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. <<<
Recent RSPI News
- Form 8-K - Current report • Edgar (US Regulatory) • 09/06/2024 12:45:11 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/02/2024 12:30:23 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/08/2024 08:01:32 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/29/2024 01:03:20 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/02/2024 01:30:27 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/22/2024 01:45:38 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/11/2023 01:45:18 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/17/2023 09:06:03 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 11/14/2023 09:05:14 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/12/2023 01:00:21 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/02/2023 12:45:26 PM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM
Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • ELMGF • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM