Replies to post #15119 on Algernon Pharmaceuticals Inc (AGNPF)

[Money $hot]

We know the standalone CC CT is penciled in for Q2 2022.

We know the timeline for SCLC is penciled in as "“People who are suffering from chemo refractory SCLC have very few options and so we are hoping to be able to move Ifenprodil directly into a U.S. clinical trial as soon as possible.” - CEO

We don't know if the IPF/CC "study" in AU/NZ will ever come to an end.

We do know the EU is the proving ground for all things DMT.



www.clinicaltrialsarena.com/analysis/psychedelics-psychedelic-drug-trials-aim-to-break-new-ground-in-mental-health/

Therefore, consider the following:

ConcernedCitizen @ yahoo finance 7 days ago

GO BACK TO MY POST ON THIS THREAD WHERE I QUOTED ALGERNON:

""Algernon Pharmaceuticals Targets First Human Study of its Psychedelic Drug DMT Stroke Program for Q4, 2021
June 17, 2021 07:00 ET"

Now look at the Press Release you are referring to here:

"Submission of the CTA application is planned for Q4 of this year."

Here's what you pressthebeat need to know and understand:

Algernon - "Files Meeting Request with MHRA for Use of DMT in Phase 1/2a Human Stroke Study".

Algernon told the market in that same Press Release - "These meetings are similar to the pre-IND meetings offered by the U.S. Food and Drug Administration."

Therefore, if you know anything about a pre-IND timeline, you'd know they have to get back to Algernon within 30 Days of the meeting request.

Meaning, Algernon will receive feedback from MHRA no later than November 12, 2021 (Day 30).

Hence, there remains 49 Calendar days in Q4 2021.

PAY CLOSE ATTENTION HERE:

Upon "Submission of the CTA application" here's the timeline to go ahead (approve), start) the clinical trial:

"The Clinical Trial Notification Scheme:
The MHRA will process the application based on the type of the trial (Type A, B or C) as described in Risk Adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products (PDF).

For certain Type A trials, the Clinical Trial Notification Scheme pages of the MHRA web site describe the process and timelines for the CTA application. Once the application is sent to the MHRA, it will be acknowledged with an accompanying note to say that the trial may go ahead after 14 days from receipt of notification if no objections have been raised. The acknowledgement letter will act as the authorisation.

For Type B and C trials, the notification scheme is not applicable and each application will be fully assessed by the MHRA. They will provide an initial response within 30 days of receipt of a valid application, with an average of 14 days for Phase 1 healthy volunteer studies. The MHRA CTA Page lists the documents required for a valid application."

Do you see where it states "an average of 14 days"?

So let's count the days.

There remains 75 days in Q4 2021.

If it takes all 30 days before Algernon receives feedback from the meeting with MHRA, that's 25 days from today. That's assuming Algernon didn't file before the day of the Press Release.

Now add the number of days it would take to receive a Clinical Trial Authorization.

Minimum number of days is 14.

Maximum number of days 30.

Add the MRHA days to the CTA days as follows:

25 days (MRHA) + 14 days (CTA) = 39 days

25 days (MRHA) + 30 days (CTA) = 55 days

Hence, in either scenario the timeline falls within 75 days remaining in Q4 2021.

I stand by my original original post which you challenged as being incorrect/innaccurate/impossible/incompetent.

"They’re supposed to start Phase 1 in Q4 2021.

Will that happen...who knows?"

CC

The Shadow Knows



Thank God It's Sunday,

M$