- Algernon Pharmaceuticals files end of Phase 2 meeting request with U.S. FDA for its COVID-19 trial of Ifenprodil
- The purpose of an EOP2 meeting is to facilitate interaction between the FDA and sponsors who seek guidance related to clinical trial design
- The FDA guidelines show that Algernon can expect a response within 70 days
- Algernon advises that it is not making any express or implied claims that Ifenprodil has the ability to eliminate, cure or contain COVID-19 at this time
- Algernon Pharmaceuticals Inc. (AGN) is up 6.25 per cent and is trading at C$0.17 at 11:08 am ET
Algernon Pharmaceuticals Inc. (AGN) has filed an end of Phase 2 meeting request with the U.S. Food and Drug Administration.
The request is based on the completion of the Phase 2b part of its Phase 2b/3 COVID-19 trial of NP-120 (Ifenprodil).
The purpose of an EOP2 meeting is to facilitate interaction between the FDA and sponsors who seek guidance related to clinical trial design, to determine the safety of proceeding to Phase 3, to evaluate the Phase 3 plan, including protocols and endpoints for adequacy, and to identify the information necessary to support a marketing application.
The FDA guidelines show that Algernon can expect a response within 70 days, although, with the topic of the meeting being a COVID-19 clinical trial, the response may be expedited.
Algernon advises that it is not making any express or implied claims that Ifenprodil has the ability to eliminate, cure or contain COVID-19 at this time.
Algernon is a drug re-purposing company that investigates safe, already approved drugs.
This includes naturally occurring compounds, for new disease applications, moving them efficiently and safely into new human trials, developing new formulations, and seeking new regulatory approvals in global markets.
Algernon Pharmaceuticals Inc. (AGN) is up 6.25 per cent and is trading at C$0.17 at 11:08 am ET.