Algernon Pharmaceuticals Inc (AGNPF)

[Money $hot]

What a difference a day, weeks, months, year can make.

www.raps.org/news-and-articles/news-articles/2020/3/new-fda-program-to-accelerate-coronavirus-treatmen

Under the coronavirus treatment acceleration program (CTAP), FDA says it is responding to requests from researchers and industry as rapidly as possible and by providing “ultra-rapid, interactive input on most development plans.”

Now that it has worked through the initial wave of requests, FDA says it intends to respond to developers within a day and will try to conduct trial protocol reviews in some cases within 24 hours. The agency says it is also working with other federal agencies, drugmakers and researchers to develop study protocols “that can be used across institutions and programs to streamline efforts.”

To date, AP is 2 Weeks into the 50 Day window (7 Weeks) awaiting an End-Of-Phase Meeting with the FDA.



regardd.org/drugs/drug-development/meetings#:~:text=The%20FDA%20will%20schedule%20the,receiving%20the%20written%20meeting%20request.

If the past is prologue expect news of the meeting sometime after Day 70.

One thing is now certain. The Phase 2 portion of the COVID "study" was never designed for EUA or Expanded Access/Compassionate Use. It was a big stinky fish (lie) that got real/reeled in at the last minute of Phase 2b. Wherein the CEO walked it all back and told everyone an EUA was likely never in the cards. Yeah, it was a great big fish story. Common shareholders caught the Big One (lie). Moving forward, the CEO has no choice (one can only hope/pray) but to stick to a predetermined set of facts for a successful COVID Phase 3 outcome - if at all.

www.raps.org/news-and-articles/news-articles/2020/5/fda-issues-two-guidances-to-accelerate-covid-19-tr

FDA guidelines

Clinical development

In the second guidance, FDA provides recommendations for clinical trial design for Phase 2 and 3 clinical trials intended to establish safety and efficacy for therapeutic or prophylactic drugs and biologics for COVID-19.

FDA says the guidance is focused on the development of direct antiviral drugs or products with immunomodulatory activity and notes that the guidance does not apply to preventative vaccines or convalescent plasma.

“FDA anticipates this guidance will help sponsors to efficiently design studies that may lead to the review and potential approval of safe and effective drugs and biological products to address the COVID-19 pandemic,” FDA writes.

Specifically, the guidance provides recommendations for study population, trial design, efficacy endpoints, safety and statistical considerations.

FDA says it “strongly recommends that drugs to treat or prevent COVID-19 be evaluated in randomized, placebo-controlled, double-blind clinical trials using a superiority design,” and that standard of care should be applied in all treatment arms.

“Sponsors should address anticipated off-label use of any other drugs, devices, or interventions that might be used to manage COVID-19,” FDA writes.

FDA opens the door to decentralized or platform clinical trials and requests that sponsors considering such studies contact the agency.

FDA also provides a list of what it considers to be important clinical outcome measures for treatment trials, including all-cause mortality, respiratory failure, need for invasive mechanical ventilation and sustained clinical recovery. For prevention trials, FDA says the primary endpoint should be the occurrence of laboratory-confirmed SARS-CoV-2 infection or SARS-CoV-2 infection with symptoms within a prespecified timeframe.

The above guidelines were in place months before the start of AP's Phase 2b/3 COVID study. Yet, we ALL held onto a pipe-line dream being fed to us through a straw.

PIPELINE

So what now? Let's whitewash past practice and move onto the next less addictive drug. DMT - "The Businessman's Trip".

Best case scenario is AP finds government, private, public sponsorship for a Phase 3 COVID trial. If it's a go it alone strategy at this point AP has failed in it's over-billed under billed "Super Cost Effective" clinical trials to date. All of them...SK, Romania/USA, AU/NZ. Outside funding, funding, funding is the only sane way to get to Phase 3. With all the independent data out there claiming there's some there > there with Ifenprodil it shouldn't be a heavy lift to get some kind of handout from somewhere around the globe.

One can only hope the money and the powers that be are focused solely on the science and not the background/credentials of Team Cobra. Only money stands in the way of proving Ifenprodil's potential to be a wonder drug. Make no mistake, this is the Inflection Point. Shareholders I've spoken to cannot and will not stomach another Pennyland PP. If so, they're bailing out of hell (Malhi's Dante's Inferno).

The best pipeline dream @ AP is a buyout of Ifenprodil. If it were possible as soon as possible I'd take the buyout in the form of stock. That being stock traded on NASDAQ or NYSE of course. We get the drug/new management/mature market/no fictitious stories/ and did I say new management?



Crazy Ch!t A!nt !t!

M$

PostScript

People way smarter than me believe holding management accountable for its actions and/or lack thereof is the present and future - Activists Investors (Electric). Silence is complacency and the past - soon to be Dead like Dinosaurs (Fossil Fuels).

investorshub.advfn.com/boards/read_msg.aspx?message_id=163972051

For a psychedelics company to succeed in the only way that matters—where all stakeholders benefit, including society at large and the natural world—we believe a company must have a model that addresses reciprocity, equitable access, philanthropy, and environmental stewardship. In other words, they must be willing to embark upon a true cost accounting of the positive and negative impacts they create through their business.

Out-ro(ar)

Phil Mickelson holes out from the bunker in the final round of the PGA Championship 2021

GO PHILLY C H E $ $ E !!!