Algernon Pharmaceuticals Inc (AGNPF)

[tcm55]

Combined Clinical Trial of Investigational Medicinal Products and Ethics Approval...

Assessment of your submission
The initial combined review assessment will be completed within 30 days of being submitted. Applications for healthy volunteer trials and sponsor-determined phase I trials in non-oncology patients may qualify for a shortened assessment time and MHRA will work with the research ethics committee to endeavour to expedite these applications. You should state on your covering letter if you think your trial is eligible. Note that trial designs that stretch to investigating the benefit of the treatment to participants may not be eligible for the expedited assessment timeframe.

We will tell you the outcome of your submission along with the outcome of the research ethics committee review, via the combined review process, which could be:

acceptance of the request for a clinical trial authorisation
acceptance of the request for a clinical trial authorisation subject to conditions
grounds for non-acceptance of the request for a clinical trial authorisation
If we raise grounds for non-acceptance you will have the opportunity to respond, usually within 14 days; however this may be extended on request.

Communication informing the applicant of the MHRA and ethics committee decision following receipt of the responses will usually be sent within 60 days of us receiving the original valid application. If an extension to the response date has been agreed this will impact the final decision timeline.


30 days for initial response from 01-19-2022. This may go fast...GLTA...

https://www.globenewswire.com/news-release/2022/01/19/2369181/0/en/Algernon-Pharmaceuticals-Files-for-Clinical-Trial-and-Ethics-Approval-for-Phase-1-DMT-Human-Stroke-Study.html