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Posted On: 04/25/2021 6:39:32 PM
Post# of 72440
Here's a cut and paste from "Call Me Crazy" at the swamp. I hope he won't
mind. I have no privleges there so I couldn't ask permission.
"CallMeCrazy Saturday, 04/24/21 06:00:12 PM
Re: None 0
Post #
356773
of 356837
W/EUA B-COVID Could Generate Billion-Dollar Sales in 2021
I believe Leo hinted at his plan to file for an EUA after B-COVID's P-2, when he said:
Quote:
Brilacidin, which has received FDA Fast Track designation for the potential treatment of COVID-19, is one of the few drugs targeting COVID-19 that has been tested in human trials (a total of
for other clinical indications, providing established safety and efficacy data on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis.
http://www.ipharminc.com/press-release/2021/3...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:
Quote:
The Gilead [COVID-19] drug therapy, which it sells under the brand name Veklury [aka remdesivir], was the first granted Emergency Use Authorization by the FDA, on May 1 [2020]. Europe followed the next month.
Gilead Sciences started charging for remdesivir in July[3Q-2020]. Given its status then as the only drug authorized for COVID-19 in the U.S., industry watchers immediately forecast multibillion-dollar sales for this year[2020].
In the third quarter[2020], Gilead sold $873 million of remdesivir, handily topping Wall Street’s previous estimate of $772 million.
But earlier this month [4Q/Oct.2020], the World Health Organization said remdesivir and three other potential Covid-19 treatments, including hydroxychloroquine, appeared to have little or no effect on hospitalized Covid-19 patients.
Gilead’s Veklury, formerly known as remdesivir, generated $2.8 billion in 2020. Most of the haul came from the fourth quarter, when hospitalizations and treatments peaked on a recent surge in COVID-19 cases, the drugmaker said. The drug pulled in a whopping $1.93 billion in the fourth quarter after generating $873 million during the third quarter of 2020.
Now, even amid vaccine rollouts, the devastating state of the pandemic means many patients are still being hospitalized around the world. Gilead is projecting $2 billion to $3 billion in Veklury sales in 2021.
https://www.investors.com/news/technology/gil...treatment/
https://www.fiercepharma.com/marketing/remdes...id-19-drug
https://www.fiercepharma.com/pharma/gilead-ex...without-it
https://www.forbes.com/sites/jvchamary/2021/0...113b5d66c2
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:
Quote:
Under section 564 of the Federal Food, Drug & Cosmetic Act (FD&C Act), the FDA may, pursuant to a
determination and declaration by the HHS Secretary, authorize an unapproved product or unapproved
uses of an approved product for emergency use. In issuing an EUA, the FDA must determine, among
other things, that the product may be effective in diagnosing, treating, or preventing a serious or life-threatening disease or condition caused by a chemical, biological, radiological, or nuclear agent; that the
known and potential benefits outweigh the known and potential risks for the product; and that there
are no adequate, approved, and available alternatives. Emergency use authorization is NOT the same as
FDA approval or licensure. EUAs do not remain in effect indefinitely and FDA will consider whether a
sponsor is working towards seeking FDA approval when evaluating the continued appropriateness of the EUA.
https://www.fda.gov/media/137574/download
Quote:
On February 9, 2021, the journal Cell Culture published a paper that concluded Brilacidin was shown to exert potent inhibitory effects on SARS-CoV-2 in cell culture by decreasing viral load in different cell types, including ACE2 positive human lung cells, and, importantly, in both the Washington and Italian strains of the coronavirus.
https://www.precisionvaccinations.com/vaccine...herapeutic
mind. I have no privleges there so I couldn't ask permission.
"CallMeCrazy Saturday, 04/24/21 06:00:12 PM
Re: None 0
Post #
356773
of 356837
W/EUA B-COVID Could Generate Billion-Dollar Sales in 2021
I believe Leo hinted at his plan to file for an EUA after B-COVID's P-2, when he said:
Quote:
Brilacidin, which has received FDA Fast Track designation for the potential treatment of COVID-19, is one of the few drugs targeting COVID-19 that has been tested in human trials (a total of
for other clinical indications, providing established safety and efficacy data on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. http://www.ipharminc.com/press-release/2021/3...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:
Quote:
The Gilead [COVID-19] drug therapy, which it sells under the brand name Veklury [aka remdesivir], was the first granted Emergency Use Authorization by the FDA, on May 1 [2020]. Europe followed the next month.
Gilead Sciences started charging for remdesivir in July[3Q-2020]. Given its status then as the only drug authorized for COVID-19 in the U.S., industry watchers immediately forecast multibillion-dollar sales for this year[2020].
In the third quarter[2020], Gilead sold $873 million of remdesivir, handily topping Wall Street’s previous estimate of $772 million.
But earlier this month [4Q/Oct.2020], the World Health Organization said remdesivir and three other potential Covid-19 treatments, including hydroxychloroquine, appeared to have little or no effect on hospitalized Covid-19 patients.
Gilead’s Veklury, formerly known as remdesivir, generated $2.8 billion in 2020. Most of the haul came from the fourth quarter, when hospitalizations and treatments peaked on a recent surge in COVID-19 cases, the drugmaker said. The drug pulled in a whopping $1.93 billion in the fourth quarter after generating $873 million during the third quarter of 2020.
Now, even amid vaccine rollouts, the devastating state of the pandemic means many patients are still being hospitalized around the world. Gilead is projecting $2 billion to $3 billion in Veklury sales in 2021.
https://www.investors.com/news/technology/gil...treatment/
https://www.fiercepharma.com/marketing/remdes...id-19-drug
https://www.fiercepharma.com/pharma/gilead-ex...without-it
https://www.forbes.com/sites/jvchamary/2021/0...113b5d66c2
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:
Quote:
Under section 564 of the Federal Food, Drug & Cosmetic Act (FD&C Act), the FDA may, pursuant to a
determination and declaration by the HHS Secretary, authorize an unapproved product or unapproved
uses of an approved product for emergency use. In issuing an EUA, the FDA must determine, among
other things, that the product may be effective in diagnosing, treating, or preventing a serious or life-threatening disease or condition caused by a chemical, biological, radiological, or nuclear agent; that the
known and potential benefits outweigh the known and potential risks for the product; and that there
are no adequate, approved, and available alternatives. Emergency use authorization is NOT the same as
FDA approval or licensure. EUAs do not remain in effect indefinitely and FDA will consider whether a
sponsor is working towards seeking FDA approval when evaluating the continued appropriateness of the EUA.
https://www.fda.gov/media/137574/download
Quote:
On February 9, 2021, the journal Cell Culture published a paper that concluded Brilacidin was shown to exert potent inhibitory effects on SARS-CoV-2 in cell culture by decreasing viral load in different cell types, including ACE2 positive human lung cells, and, importantly, in both the Washington and Italian strains of the coronavirus.
https://www.precisionvaccinations.com/vaccine...herapeutic
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