Saturday, April 24, 2021 6:00:12 PM
I believe Leo hinted at his plan to file for an EUA after B-COVID's P-2, when he said:
http://www.ipharminc.com/press-release/2021/3/10/innovation-pharmas-covid-19-drug-candidate-brilacidin-ranked-in-top-three-percent-of-compounds-predicted-to-be-most-effective-against-sars-cov-2
I'm sure Leo knows that the only way for B-COVID to "rapidly help" with the "coronavirus crisis" is through an EUA for which the bar,set by Gilead's remdesivir, is low in terms of efficacy against COVID-19. I'm sure Leo is also aware of the financial windfall that befell Gilead after their re-purposed drug for SARS-CoV-2, therapeutic-drug candidate, remdesivir, achieved Emergency Use Authorization:
https://www.investors.com/news/technology/gild-stock-rises-gilead-sciences-gets-fda-ok-covid-19-treatment/
https://www.fiercepharma.com/marketing/remdesivir-sales-hit-873m-as-gilead-gets-defensive-against-who-data-covid-19-drug
https://www.fiercepharma.com/pharma/gilead-expects-a-blockbuster-2021-for-coronavirus-drug-veklury-but-can-grow-even-without-it
https://www.forbes.com/sites/jvchamary/2021/01/31/remdesivir-covid-coronavirus/?sh=57113b5d66c2
To Recap:
In July of 2020, just 2 months after achieving an EUA, and early in the 3Q-/2020, Gilead began selling remdesivir for COVID-19 and had 3Q/2020 sales of $873M. Then, EARLY, in the 4Q (Oct.2020), the World Health Organization (WHO) declared remdesivir to have little to no effect on COVID-19 as remdesivir went on to post 4Q-2020 sales of nearly $2B, while projecting 2021 sales of $2B-$3B.
Why not B-COVID?
B-COVID's P-2 should end in July 2020 and the evidence, pre-clinical testing at independent laboratories, selectivity index of 426 and a molecular screening study of 11,552 compounds, suggest that B-COVID's P-2 results will reveal a higher efficacy against SARS-Cov-2 than clinically shown by remdesivir. Logically, this is all that is required for B-COVID to earn an EUA, since B's safety has already been established.
I believe Leo has the B-COVID EUA already prepared and is merely waiting to insert B-COVID's Post-P/2 data onto the application prior to submission to FDA. I further believe Leo will achieve an EUA for B-COVID within weeks of the, July 2020, conclusion of the phase 2,but before the start of the 4Q (Oct. 2021)
The need for a COVID-therapeutic drug, NOW, is as great as it was when Gilead began selling remdesivir for COVID-19 in July 2020. The virus was surging then as it is now. Currently, in 'The World's Largest Democracy, India, with a population in excess of one billion people, COVID-19 infections are occurring at the rate of 332k a day. Variants are threatening vaccine efficacy and vaccine production problems are slowing the already slow-rate of world vaccination.
I feel confident that Leo, with EUA in hand, could write a billion dollars in sales for B-COVID by end-of-year 2021. Leo could do this without a partner, but I think Leo's biggest problem will be finding mega-manufacturing capacity, not a partner. The billion-dollar buyers, namely governments and other global entities, will be stockpiling an efficaceous B-COVID, hundreds of millions of doses at a time, just like they did remdesivir. The only question remaining in my mind:
Is Gilead Eyeing A Partnership With IPIX?
Once Leo releases B-COVID's P-2 results I think that one of the most interested parties will be Gilead Sciences because a therapeutic-COVID drug more efficacious than remdesivir will likely eat, heavily, into their multibillion-dollar remdesivir sales pojections. In short, Gilead has the most to lose, financially, from an EUA approved B-COVID and probably the party most interested in doing a partnering deal with IPIX (B-COVID), but, as I previously stated, with or without a partner for B-COVID and with EUA in hand Leo could:
...Generate Billion-Dollar Sales in 2021
FYI:
https://www.fda.gov/media/137574/download
https://www.precisionvaccinations.com/vaccines/brilacidin-covid-19-therapeutic
Recent IPIX News
- Form 8-K - Current report • Edgar (US Regulatory) • 02/01/2024 01:30:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/05/2023 09:25:58 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/20/2023 09:05:44 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 11/15/2023 01:00:19 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2023 08:15:25 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 09/28/2023 01:00:08 PM
Bantec Reports an Over 50 Percent Increase in Sales and Profits in Q1 2024 from Q1 2023 • BANT • Apr 25, 2024 10:00 AM
Cannabix's Breath Logix Alcohol Device Delivers Positive Impact to Private Monitoring Agency in Montana, USA • BLO • Apr 25, 2024 8:52 AM
Kona Gold Beverages, Inc. Announces Name Change to NuVibe, Inc. and Initiation of Ticker Symbol Application Process • KGKG • Apr 25, 2024 8:30 AM
Axis Technologies Group and Carbonis Forge Ahead with New Digital Carbon Credit Technology • AXTG • Apr 24, 2024 3:00 AM
North Bay Resources Announces Successful Equipment Test at Bishop Gold Mill, Inyo County, California • NBRI • Apr 23, 2024 9:41 AM
Epazz, Inc.: CryObo, Inc. solar Bitcoin operations will issue tokens • EPAZ • Apr 23, 2024 9:20 AM