Replies to post #11560 on Algernon Pharmaceuticals Inc (AGNPF)

[smoki]

https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track

[shell3]

Need to reread the second paragraph again

The choice of the primary outcome measure will be determined by a pilot study of the first 150 subjects. Subject clinical status (on a 7-point ordinal scale) at day 15 in treatment versus the control group is the default primary endpoint.

The 682 is the Phase 3 part — And I’m no Doctor but I believe that’s what the 682 number has included

JMO

https://clinicaltrials.gov/ct2/show/NCT04382924?term=algernon&draw=1&rank=1

[Money $hot]

CSE's Barrington Miller was recently joined by Christopher Moreau, CEO of Algernon Pharmaceuticals Inc. (CSE:AGN), to discuss his company's work to develop NP-120 (Ifenprodil) as a new therapeutic in the fight against COVID-19.

In this discussion, Chris outlines how his company focuses on drug re-purposing, a term that is widely understood through the example provided by Viagra (1:04), the important distinction between therapeutic treatments and anti-virals and vaccines (12:14), and why the "grandaddy" of all market approvals is from the USFDA (18:25).

Listen until the end to hear how the company's name is actually inspired by the title of a science fiction novel, and how the company has a history of investigating compounds developed by the Soviet Union!

(Subsequent to this chat, Algernon announced Health Canada approval to move forward with its PH2b/3 trial here with Ifenprodil as a potential treatment for COVID-19.)

Related Link
algernonpharmaceuticals.com

CSE TV
May 4, 2020
@ 16:30 min/sec of video

So we're talking 90 days and now next step would be is the data powerful enough. So what's the statistical significance. How well powered do we then need to go into a Phase 3. Can we make a case to the regulators that in fact the data is so strong we may not need a Phase 3.

FULL STOP

The above webcast is dated May 4, 2020. Over 4 months ago we were told there's a possibility of a drug approval after a 90 day clinical trial process. To my knowledge and understanding of the video, CJM was referring to the South Korea study and the multinational clinical trial. Whichever is completed first. The SK study was scheduled to begin May 8, 2020. The multinational clinical trial started July 7, 2020. Therefore, reasonable minds would have been able to conclude a data readout would have taken place in August 2020 from SK study and/or October 2020 from the multinational clinical trial. As of today, based on what CJM has most recently stated, a clinical trial data readout will likely be in December 2020.

To be clear, we were led to believe an FDA approved drug for COVID-19 was possible as early as August 2020 and no later than October 2020. I am unaware of a drug gaining market approval at Phase 2 of the process. That is a question I would pose to someone with more knowledge in that area. Nonetheless, we are well beyond the timeline of those "Inflection Points" as previously described. So consider this post as simply a point of information. Including the 682 participants you made reference to in your post. Subtracting 150 participants from the 682 participants and the remaining participants is my best guestimate of how many patients would be needed for a Phase 3 clinical trial.

Just 1 opinion,

/////AMG

Postscript

ssbains

We need 2 catalysts and he has some incredible insight.

Thanks for the kind words Doc. I assure you, I have much more hindsight than insight. I am delighted to see the other clinical trial locations have been updated at clinicaltrials.gov. Given the recent mention of Bucharest, I assumed we scrapped the US locations discussed more than 2 months ago (11 weeks ago today). Did I overreact - probably? However, one must understand I have absorbed this stuff and hung onto every word CJM has spoken since he stepped from behind the desk at Breathtec and introduced himself. If you've hung around as long as I have and chronicled the story (3 CEO's) as best as you can, you'd understand why my patience runs hot like a wick from a TNT stick lit by John Wick.