Algernon Pharmaceuticals Inc (AGNPF)

[Money $hot]

Real World Time Lines for COVID-19 Treatments from Data Readout to Emergency Use Authorization (EUA)


Eli Lilly - bamlanivimab

October 07, 2020 http://lilly.mediaroom.com/2020-10-07-Lilly-provides-comprehensive-update-on-progress-of-SARS-CoV-2-neutralizing-antibody-programs

November 09, 2020 http://lilly.mediaroom.com/2020-11-09-Lillys-neutralizing-antibody-bamlanivimab-LY-CoV555-receives-FDA-emergency-use-authorization-for-the-treatment-of-recently-diagnosed-COVID-19


REGEN-COV - (casirivimab and imdevimab)

September 29, 2020 https://investor.regeneron.com/news-releases/news-release-details/regenerons-regn-cov2-antibody-cocktail-reduced-viral-levels-and

November 21, 2020 https://investor.regeneron.com/news-releases/news-release-details/regenerons-regen-cov2-first-antibody-cocktail-covid-19-receive


Gilead - (remdesivir)

- Re: Severe COVID-19 Patients

April 10, 2020 https://www.gilead.com/news-and-press/press-room/press-releases/2020/4/data-on-53-patients-treated-with-investigational-antiviral-remdesivir-through-the-compassionate-use-program-published-in-new-england-journal-of-medici

April 29, 2020 https://www.gilead.com/news-and-press/press-room/press-releases/2020/4/gilead-announces-results-from-phase-3-trial-of-investigational-antiviral-remdesivir-in-patients-with-severe-covid-19

May 1, 2020 https://www.gilead.com/news-and-press/press-room/press-releases/2020/5/gileads-investigational-antiviral-remdesivir-receives-us-food-and-drug-administration-emergency-use-authorization-for-the-treatment-of-covid19

October 22, 2021 https://www.gilead.com/news-and-press/press-room/press-releases/2020/10/us-food-and-drug-administration-approves-gileads-antiviral-veklury-remdesivir-for-treatment-of-covid19

- Re: Moderate COVID-19 Patients

June 1, 2020 https://www.gilead.com/news-and-press/press-room/press-releases/2020/6/gilead-announces-results-from-phase-3-trial-of-remdesivir-in-patients-with-moderate-covid-19

August 18, 2020 https://www.gilead.com/news-and-press/press-room/press-releases/2020/8/gileads-investigational-antiviral-veklury-remdesivir-receives-us-food-and-drug-administration-emergency-use-authorization-for-the-treatment-of-p

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Timeline from Data Readout to EUA

Eli Lilly - 33 Days

Regeneron - 53 Days

Gilead - 78 Days for Moderate COVID-19

Gilead - 2 Days for Severe COVID-19

As it relates to Regeneron's 2 Day turnaround for Severe COVID-19 patients I believe is due to an ongoing collaborative relationship with the FDA and multiple clinical trials for remdesevir. Already having compiled and continuously updating data throughout the trials likely gave them the fastest track ever to an EUA.

Therefore, if we throw out the "2 Day" timeline as inconclusive, the average time to get EUA after a data readout is 55 Days.

33 Days + 53 Days + 78 Days = 164 Days ÷ 3 = 55 Days

I posted 2 additional links from Gilead that provides some indication to how long it may take to get an FDA approval after an EUA.

Gilead did it in 174 Day = 5.721 months

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So one could look at the above and apply it to Algernon's pending Data Readout and assume there would be an additional 55 Days added to the timeline for an EUA approval.

I personally have a 4 to 6 week time frame after the March 5th Datalock before the Data Readout. It's purely speculative, but I based it on tracking other biotech's data reporting activities. I'm not just pulling sh!t out of my @ss, I'm trying to do real world due diligence. If we get the report next week awesome! If not, we plod along as usual until such time.

^This timeline in total represents approximately 3 months from a Database lock to an Emergency Use Authorization. I'm taking the long view with the understanding that not many critical timelines have been met. I'm leaving plenty of room to let it play itself out.

IF All ELSE FAILS



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