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Thank you for your enlightened response. I agree.
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From what I can tell, Tavalisse did not receive Fast Track designation, so the trial design conversations with the FDA probably didn’t happen. That is an advantage Brilacidin has over it.
The trial design meetings with the FDA should have ensured that enough was enough.
I think the Rigel CEO made it clear that the reason the EUA was denied was because of not enough data because of too few trial participants (59).
As ROMAD Diver pointed out to me in post# 370385:
Leo's best skill might be clinical trial management
considering that:
Bad actors have timeline for IPIX price manipulation
From the August 12th PR:
Here's how Lambda variant could increase B-COVID's value
Lambda COVID variant has taken toehold in America
This issue will be a positive for IPIX
But, I think John Hopkins gives a more honest and credible assessment of this issue.
Interesting source (NewsRescue) you have.
Here's part of the analysis of NewsRescue by Mediabiasfactcheck.com
You seem to imply "NewsRescue" is credible.
Here's part of the analysis of NewsRescue by Mediabiasfactcheck.com
Here's Another Erroneous Headline From Your Source: NewsRescue
There is support for Biopa's post# 369279
Biopa said:
Not Either/Or: Mankind needs COVID Vaccines and Therapeutics
You said:
After B-COVID'S "presumably" stellar P-2 results: What next?
Obviously, IMO, EUAs are first. Beginning with the U.S. then the WHO, India & the EU. Here's what seems to be lost on many here. After B-COVID's successful P-2 and EUA...B-COVID is MONETIZABLE in the billions...RIGHT NOW!
While the first-world countries (U.S.,UK, Canada, etc) are more than 50% fully vaccinated, by comparison:
IMO, the only person that matters is Leo and he's not about to sell IPIX for such a pittance.
You said:
Another motivation for Gilead to come to table:
The evidence suggest you are wrong.
You said:
No Proof of B-COVID Efficacy Against Delta Variant
You said:
Page 7 of ASV Presentation Suggest you're wrong
You said:
Leo! I like the way you think.
I said (post # 362359 on June 16, 2021):
What C-19 did for Moderna, it will/do 4-IPIX
Role of An Antiviral in Fight Against Virus
Delta Variant Outbreak in (85% Vaccinated) Israel
I don't expect IPIX to have clinical-proof of B's efficacy against the delta variant in B's P-2 results, but if it does an EUA from the FDA will fall quicker than a drunken-soldier's underwear in a house of ill-repute, because:
Projections for the future value of the antiviral drug market (AVDM) between now and 2030 have been all over the place but this Market Insight Report suggest your number is WAY OFF.
This report, which states the AVDM was $44B in 2020, was published in March 2021 so, presumably, hindsight is 20/20.
I'm disputing your number, NOT your outlook.
https://www.gminsights.com/industry-analysis/antiviral-drugs-market
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I agree. This is so much more than Covid. Covid is the platform and a great opportunity in itself, but the antiviral possibilities and new patents that will arise with many reformulation hopes are endless in a 44 billion market by 2026.
Let’s hope for good data and more data
Purchasers of COVID Therapeutics For Poor Countries
What's your sources or RU just making assertions?
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It’s flawed logic to assume that brilacidin would be purchased by countries that cannot afford to vaccinate their populations (third world countries). If a country can’t afford $25 to vaccinate they are unlikely to be a viable market for a costly drug like brilacidin with a complicated method of delivery.
As to vaccinations . . . I think it’s a lack of historical knowledge to suggest that the rate of vaccination is slow. Vaccinating 2.4 billion people in 6 months is nothing short of astounding. And don’t forget that the people being vaccinated first are those most susceptible to COVID.
We all know that the antiviral market is huge, but it was also huge when brilacidin was developed by Polymedix. Why wasn’t brilacidin developed as an antiviral by Polymedix?
The Need For COVID Therapeutics are GREAT!
https://www.ama-assn.org/delivering-care/public-health/covid-19-therapeutics-what-evidence-shows
First world countries have been monopolizing most available effective vaccines and I believe they will do the same when more effective COVID drugs/treatments become available. These countries aim to satisfy their respective public health, national security and philanthropic needs. Looking at COVID via first world countries will lead to an incorrect view of the pandemic.
This is a worldwide pandemic and that is also the perspective to take when talking about COVID therapeutics. Fact #1: Only about 30% of the global population is vaccinated (2.4B of 7.8B). It has been estimated that the global population will not achieve a 70% - 80% vaccination rate until 2025/2026.
Perhaps you missed the market growth projections for the antiviral drug market:
https://www.businesswire.com/news/home/20210210005504/en/Global-Anti-Viral-Drug-Therapy-Market-2020-to-2030---Opportunities-and-Strategies-with-COVID-19-Implications-and-Growth---ResearchAndMarkets.com
Anyone who care to take a cursory look at the global antiviral drug market and growth projections can easily see that by 2030 the only market bigger than this one is CANCER.
To say "that need appears to be modest" is to signal a misunderstanding of a market projected to more than double by 2030.
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The usefulness of a vaccine isn’t that you don’t get the virus at all, but rather that when you do get the virus your immune system is prepared to fight it off. That’s basic stuff. In fact, the article says that, “. . . most of the new cases among vaccinated persons are mild . . . .”
Nothing is 100% so there will always be a need for therapeutics, but that need appears to be modest based upon the number and efficacy of the vaccines and the rates at which they are being administered.
What I'd like to ask you is: As Russia seeks to boost its credentials as a location for international trials, what would Putin gain by interfering in an international COVID trial when many Russians don't trust the Russian Government and their "Sputnik" vaccine and won't take anything from the Puitin's government?
https://www.themoscowtimes.com/2021/05/17/42-of-russians-wont-get-coronavirus-vaccine-under-any-circumstances-poll-a73912
https://www.pharmaceutical-technology.com/features/featurerussia-a-bright-future-for-clinical-trials-4872809/
Putin is not under any internal pressure to produce anything for COVID and most Russians would probably be happy without any COVID input from the Putin administration.
If Putin were to take the actions you think him capable then he would clearly be doing himself more harm than good. He would be tarnishing his country's international reputation as a good location for international clinical trials and all for a treatment that it's doubtful Russians would even use.
Putin may be a highly-despicable human being but I've never heard anyone accuse him of being stupid.
Elements of A Global Business Strategy For B-COVID
If I were to encapsulate a one-phrase policy that best describes the first world countries behaviors towards (U.S.,U.K,EU,etc) the first available effective vaccines would be:
[We're looking out for number one: FIRST]
I think this "policy" could form the basis for IPIX's B-COVID global-strategy.
First world countries have been monopolizing most available effective vaccines and I believe they will do the same when more effective COVID drugs/treatments become available. These countries aim to satisfy their respective public health, national security and philanthropic needs.
In the U.S., for example, 44% of the population is fully vaccinated and the need for an effective COVID-therapeutic drug is not as great as the need in, say, India, but U.S. national security considerations have created the need for the U.S. to stockpile COVID therapeutics because the U.S. military must operate all over the globe and presently only 30% of the globe's population is vaccinated. Little wonder Biden's investing billions in the research, discovery and manufacture of antivirals.
I hope Leo is lining-up BP mfg. COVID-19 is the hottest ticket in all of pharma and those non-participating BPs want in. I see Leo's bargaining strength as such that he might be able to negotiate enough upfront "partnering-fees" to finance or substantially finance a B-COVID P-3.
Will Brilacidin safety data on 470+ clinical trial participants, pre-clinical data (that will be presented at 2021 ASV & MHSRS), and clinical data from B-COVID's P-2 be enough to convince the FDA that B-COVID...MAY...be effective against COVID-19, which would allow them to issue an EUA? I THINK IT WILL.
First world countries are "low-hanging fruit" in that they'll probably make contact with Leo (for the above mentioned reasons) before he makes contact with them. First world vaccine hoarding has created a situation where, in the absence of vaccines, the Third World has the greatest need for COVID therapeutics.
I think part of Leo's strategy should be aimed at acquiring large mfg capacity in third world countries. India has a large pharma-mfg base and,IMO, would be an excellent first choice for obvious reasons.
First world countries will also be buying COVID therapeutics to give to poor countries, but there are also global organizations that will be buying COVID therapeutics for poor countries and Leo should have a plan on how to capitalize on the therapeutic spending sources for the billions of unvaccinated people living in third world countries.
The effective COVID vaccines are slowly making their way though the world, from first to third. But I think a good global strategy for the distribution of an effective COVID therapeutic (B-COVID) would be to do the opposite and to distribute from third world to first world.
Our problem is speed not competition. The EUA should be acquired as quickly as possible so we can be among the first COVID drugs/treatments available. There's room for a handful of companies to make a ton of dough in this space.
Leo! Let's not be so busy working (pipeline development) that we for get what we're working for (MONEY). We need to make this money now so we can control our future. This requires planning on a grand scale. I hope the planning is underway.
Mine too! "New data" for the EUA application, if this data is different from the data being presented at the Annual Virologists meeting in July 2021.
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“ New data supporting Brilacidin’s broad spectrum antiviral properties will be presented at the 2021 MHSRS conference, ” this is my favorite part!
IPIX NEWS: Innovation Pharma Announces New Brilacidin Antiviral Research on Non-SARS-CoV-2 Endemic Viral Diseases to be Presented at the 2021 Military Health System Research Symposium
Presentation to be part of the “Development of New Front Line Therapies to Prevent and Treat Non-SARS-CoV-2 Endemic Viral Diseases” Breakout Session
WAKEFIELD, MA – June 18, 2021 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announced that antiviral research related to Brilacidin has been accepted for an Oral Presentation at the 2021 Military Health System Research Symposium (MHSRS), taking place August 23-26, 2021, at the Gaylord Palms Resort and Convention Center, Kissimmee, FL.
The MHSRS is an annual four-day scientific symposium sponsored by the U.S. Department of Defense. The presentation on Brilacidin will be part of the “Development of New Front Line Therapies to Prevent and Treat Non-SARS-CoV-2 Endemic Viral Diseases” Breakout Session. Out of nearly 2,300 submissions, approximately 20 percent were accepted for presentation.
New data supporting Brilacidin’s broad spectrum antiviral properties will be presented at the 2021 MHSRS conference, as well as during a separate oral presentation on Brilacidin to be delivered at the American Society of Virology’s 40th Annual Meeting, to be held in July.
https://mailchi.mp/ipharminc/brilacidin-antiviral-research-on-non-sars-cov-2-endemic-viral-diseases-to-be-presented-at-the-2021-military-health-system-research-symposium?e=d6a81bdb11
The Vaccine Divide - Why B-COVID is needed NOW!
This short video reveals why it is foolish to think the pandemic will be over anytime soon. The slow progression of vaccines throughout the world will only increase the need for therapeutics in general and B-COVID specifically.
Lots of talk in the video about waiving intellectual property rights, but I'm not interested in that discussion since I'm confident it's a non-starter.
Also not interested in conspiracy theories of BP, FDA, Bill Gates or who shot J.R.?
A very informative video regarding the sad state of affairs of the global battle with and for COVID vaccines and the pandemic. Need for therapeutics not mentioned but apparent.
https://theintercept.com/2021/06/15/vaccine-divide-covid/?utm_medium=email&utm_source=The%20Intercept%20Newsletter
"I guess you felt it important to correct me."
I wasn't even communicating with you. I was responding to Steelyeye's remark that he was essentially filing the quote away for future use. I thought if he was going to do that then he should use the actual quote. Here is the quote from a respected quotation website:
https://www.brainyquote.com/quotes/thomas_a_edison_132683
The U.S. EUA is important for 2 reasons:
1. U.S. Government will be the first customer, probably with a billion-dollar order. The U.S. will want to stockpile,distribute (in U.S.) and give B-COVID, in large numbers, to global organizations that will distribute to the poor countries.
Lemoncat said:
The first mistake is to look at COVID eradication in terms of the U.S., U.K., EU, and other first world countries.
B-COVID's perspective is a global one. The total world population is 7.8B and the total number of people vaccinated in the world is JUST 2.4B. I've read estimates that the world won't be vaccinated until roughly 2025/2026.
The U.S. EUA is important for 2 reasons:
1. U.S. Government will be the first customer, probably with a billion-dollar order. The U.S. will want to stockpile,distribute (in U.S.) and give B-COVID, in large numbers, to global organizations that will distribute to the poor countries.
2. After the U.S. EUA, EUAs from around the world will fall like dominoes. The FDA's stamp of approval is a worldwide door opener. The next EUAs I'd like to see is The WHO and the EU and India. These EUAs are the most valuable.
Number Two is also the reason one BP won't do. As Pfizer or Merck will tell you, one BP cannot supply the world. This is why there is room for other therapeutics, but being among the first is important because when doctors get used to prescribing a drug that gives them the desired outcome, this habit is hard to break.
Lastly, COVID-19, I believe, should be viewed as Brilacidin's "gateway indication" on its way to becoming a sorely-needed, broad-spectrum, anti-viral in a market projected to be worth $87B in 2025.
https://www.businesswire.com/news/home/20210210005504/en/Global-Anti-Viral-Drug-Therapy-Market-2020-to-2030---Opportunities-and-Strategies-with-COVID-19-Implications-and-Growth---ResearchAndMarkets.com
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"If anything IPIX has 10,000 suitors most of whom will fail because all IPIX need is a handful of BP with large manufacturing capacity. "
Well, at the rate COVID is being eradicated by the vaccines one BP will do. Maybe even just Alfa Sigma.
Go IPIX!
Perhaps you'd like to use the actual quote.
“I have not failed. I’ve just found 10,000 ways that won’t work.”
-Thomas Edison
https://due.com/blog/thomas-edison-10000-ways-that-wont-work/
If anything IPIX has 10,000 suitors most of whom will fail because all IPIX need is a handful of BP with large manufacturing capacity.
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Love the semantic twist and the quoted author. I've already added it to my pro and con list. Thanks!
Biotech To Present Antibody data/July Medical Meeting
IPIX MIGHT BE NEXT...TOLD YOU SO!
The self-described “cytokine storm company” filed a rolling submission in the U.K. Monday for [EU] authorization of lenzilumab to treat hospitalized COVID-19 patients. This follows a May 28 [EU] authorization filing to the FDA...
The therapy could become a standard of care and bring in $1 billion in sales in the first 12 months, the firm estimated. Humanigen currently has no product sales...
Lenzilumab’s submissions are supported by data from a phase 3 clinical trial called LIVE-AIR that found a 54% improvement in the likelihood of survival without ventilation among patients who received the therapy. When paired with corticosteroids and remdesivir, that improvement jumped to 92%. Patients did not suffer any adverse events, and lenzilumab's safety was comparable to placebo.
Humanigen met its goal of filing for FDA [EU] authorization by June. The company also wants to get the therapy cleared for a full approval, but the agency is likely to request more trials first.
While several therapies are available for certain COVID-19 patients, the field remains wide open for new ones that can help critically ill people.
"Despite vaccine uptake, there continues to be a need for proven therapies that are variant-agnostic for patients that remain at risk of COVID-19," said Humanigen CEO Cameron Durrant. "Now, with applications in the U.S. and in the U.K., we feel we can help tackle this global challenge. We hope to provide a powerful solution for hospitalized patients on both sides of the Atlantic."
Humanigen's therapy is also under development for other conditions that involve cytokine storm, including acute graft-versus-host disease. Lenzilumab hit its primary goal in a phase 3 trial testing its ability to prevent or treat hyperinflammation or cytokine storm. A phase 2 study for the same indication is sponsored by the National Institutes of Health.
https://www.fiercebiotech.com/biotech/humanigen-angling-to-go-from-zero-to-1b-us-uk-covid-19-therapy-filings?mkt_tok=Mjk0LU1RRi0wNTYAAAF9qkmeN3nZiLu3Pix42zvOEk2O67oeDO4ZORv1zQvmMWDFrfVy37F0Kd090FJmFB_fkGPL73ATCQ1M5g_JU199iS0wlX15rzKKNNottHzftfyaSws&mrkid=762402
In terms of efficacy, the FDA/EUA requests:
THIS IS NOT BIGGER THAN B-COVID
B-COVID is the gateway indication into the development of "B" as a broad-spectrum anti-viral.
Strategicly, B-COVID is the only indication that has reduced efficacy requirements that could allow B-COVID to become available and revenue generating this year (2021).
For all of B's promise as an broad-spectrum antiviral in a market projected to hit $44B in sales in 2026, B, with the exception of B-COVID, is still years away from generating any revenues and will take additional years to ramp up to the hundreds of millions/billions sales that B-COVID could easily make in a relative few short months.
IPIX needs the B-COVID money to finance the development of B as a broad-spectrum anti-viral and the Kevetrin platform, possibly simultaneously.
Developing our pipeline without the need for partnering is the opportunity presented by the COVID-19 Pandemic. Partnering after a highly-successful P-3 is the way to go. This is also the best way to maximize the value of our pipeline.
Whatever indication you think IPIX should focus on, ask yourself one question about that indication:
1. Considering the clinical trials that need to be completed---HOW LONG BEFORE THIS INDICATION GENERATES REVENUES?
Priorities is the operative word here. I'm suggesting that Leo should be presently focused on quickly monetizing B-COVID. A B-COVID EUA is worth billion$ with the proper infrastructure in place. Leo, let's get those EUA sales rolling in and simultaneously plan a B-COVID P-3 and then look at expanding the label usage.
If IPIX has an asset that it can use to finance the development of its pipeline; while simultaneously eliminating the need for a pipeline development partner, CALLMECRAZY, but isn't that what IPIX should be doing?
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Here is a list of the many alphaviruses that B will eventually destroy:
https://www.ncbi.nlm.nih.gov/genomes/GenomesGroup.cgi?taxid=11019
Remember, this is bigger than covid-19......good day all!!!!!!!!