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The Power of the Pandemic Changes Everything
The world's best-selling drug, Humira, took 15 years for its sales to go from $250M in 2003 to nearly $20B in 2018.
By comparison:
This indication has a low bar for success, which increases my optimism about B-COVID.
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After reading that it doesn’t look that successful.
Bio Seeks EUA Path After Successful C-19 P-2
Yes and within the area you highlighted this is my favorite:
Quick read: Last 4 paragraphs of full text (Discussion)
Nationally, COVID-19 deaths and infection are up 2%.
To your point:
Excellent points.
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Yes, which leads to two additional points:
At the last shareholder meeting, over 90% of share holders voted YES to increase the share issuance to 600M.
This is a vote of confidence for both Leo's frugality and confidence he would use shares to further the company going forward.
Relative to competitors, IPIX share price has some catching up to do, and with a successful PH 2, I wouldn't be surprised if the IPIX market Cap surpasses the others listed.
Essentially, "B" works by puncturing the membrane and
Conditions are ripe for more coronavirus variants
Brilacidins MOA suggest no worries with Brazilian strain
Gastrointestinal self-guided drug delivery device enters P-1
Yes, the inabilities of some is, indeed, funny.
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'CallMeCrazy " to follow reasoned speculation."
Now that's good !!!! LOL
There's a lot of things Leo hasn't mentioned hence the need for rational speculation.
Do you honestly believe Leo is STUPID enough to let you know everything he knows when he knows it? (Rhetorical question)
You engage in wild speculation when you state," It's almost like he's satisfied for phase 2 and will reevaluate strategy once results are known." What basis do you have for implying Leo is "satisfied"? What basis do you have for knowing when or if Leo intends to "reevaluate strategy"?
Given the fact that a B-COVID P-3 would cost much less in Russia than the U.S.and given that the reward of not having to give up a large percentage to BP, and further given that IPIX might have the financial wherewithal to pay for said P-3, I think this is a fairly simple decision.
Here's the reason Leo WISELY shelved Absssi:
I agree, but one must differentiate between reasoned speculation and wild speculation. IMO, rational speculation is fun.
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It is fun speculating.
I'm something of a "big picture" person and have no wish to wander into the "weeds" P-2 recruiting.
Simply put, my hope is that IPIX successfully complete a Russian P-3 sometime in 2021, setting up B-COVID to hit the market early in 2022.
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Would not be a surprise if P-2 lasts until summer... Heck, it took how long to get a projected Q4 trial recruited and it's not completed.
The Russian change of the clinical trial end date from March 2021 to Sept. 2021 suggest the possibility of a transition from a P-2 to P-3.
What I find "unbelievable" is your apparent inability to follow reasoned speculation.
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CallMeCrazy Really Sept? And you consider a slip of 6 months good news. Unbelievable.
More evidence Leo is anticipating B-COVID-P/3 in Russia
What your comparison also indicates to me is that Leo has kept dilution to a minimum.
(Appreciate your laudatory remarks regarding my posts)
Could Leo be anticipating B-COVID P-3 in Russia.
In my reference post I assigned a "ballpark" figure of $22M to a B-COVID P-3. I used the average of a study of phase 3's ($19M) and applied a cumulative price increase of 10% and added a million.
https://www.raps.org/news-and-articles/news-articles/2018/9/phase-3-trial-costs-estimated-at-19m-study-finds
Conducting a P-3 in Russia might not even cost that much.
When you've got the goods you don't need the hype. What do you mean "garner attention". Sounds like you're referring to the retail stock investor because BP is already aware of Brilacidin.
Leo is not going to give up billions if he is able to handle the B-COVID initial roll-out and retain those billions that would have gone to BP, who would only have to manufacture and deliver the drug in bulk.
I believe the difference in Leo and your thinking is that Leo isn't willing to give up many billions of dollars of value for a few billion in return.
"Gilead's Remdesivir has brought in 150 billion during the last year", Where did you get this from?--- NEWSFLASH: According to Fierce Biotech, the top-selling drug for 2020 was AbbVie's Humira with sales totaling roughly $16B. In fact, the top ten best-selling drugs in 2020 wouldn't total $150B.
https://www.fiercepharma.com/special-report/top-20-drugs-2020-worldwide-sales
Additionally, Yahoo Finance states that Remdesivir only had $1.9B in sales in the 4Q/2020, the year's worst quarter for COVID. And in 2020 Gilead had total sales of $24B. Your $150B remdesivur statement seems highly inaccurate.
I did note one thing remdesivir and brilacidin have in common: They both were/are being developed with assistance from the U.S. government.
https://www.statnews.com/pharmalot/2020/05/08/gilead-remdesivir-covid19-coronavirus-patents/
Obviously, Gilead would want to buy a drug that threatens to shrink the sales of remdesivir, but others are probably interested too. It is competition that will yield the highest price for B-COVID. The highest value will come if Leo can pull off a P-3, cut out the middleman and negotiate directly with the various entities buying in bulk.
Again, if B-COVID, in its first year on the market, can do in sales what remdesivir did in 4Q/2020 ($1.9B) then IPIX will have more than enough money to develop its' entire pipeline.
IMO, the pandemic has changed things so favorably for IPIX that Leo may now be considering the possibility of taking some or all of our lucrative indications through P-3, where they have their highest values and his negotiation position strongest, before partnering. Leo is not one to leave lots of value on the table if he has viable alternatives.
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You don't believe a Phase 2 and an EUA would garner attention? Gilead's Remdesivir has brought in 150 billion during the last year as a result of being approved for the EUA, for Rendesivir, but Brilacidin is practically worthless according to many posters, until it goes through the phase 3 trials? I don't subscribe to that.I believe Brilacidin would be a multi-billion dollar company as soon as Brilacidin is recognized as a top line Therapeutic for Covid 19, I don't believe Gilead would hesitate to pay Billions for Brilacidin if they think they could leverege the product like they have with Remdesivir. Take a look at the Phase 3 Remdesivir if you want to see what their phase 3 trial looked like. Anyone want to calculate what the discounted future value for IPIX would be if it preforms as expected?
Ironically, successful P-2 lessens chance for B-COVID deal I think.
Leo and his "maximize value" mindset knows that a B-COVID partnering deal has the most value after a phase 3. But how much would a phase 3 cost? Perhaps this will establish a reasonable baseline from which to address this question:
Hopefully, IPIX will benefit from Biden's COVID Bill.
Vaccine sales suggest big money ahead for IPIX
Moderna has sewn up $18 billion in COVID-19 vaccine orders—and it's negotiating more
Updated COVID-19 therapeutic tracker list "B" as pre-clinical
You will find Brilacidin listed 13th from the end of the drug list.
https://biorender.com/covid-vaccine-tracker?utm_campaign=COVID-19+Weekly+Updates%3A+February+15-22&utm_content=Long+Subject+Line&utm_medium=email_action&utm_source=customer.io
It is clear that our B-COVID trials have a level of secrecy that "longs" have never seen. Leo's PR behavior is markedly different from his past PR behavior, but what is not clear is why some think that Leo's PR behavior should never change no matter what?
You say, "Leo isn't giving you enough info to figure out what's going on", that's probably by design.
Present share price be damned...I love Leo's NEW "Manhattan Project" secrecy-level PR behavior. Ultimately, I think it will yield the biggest bang for IPIX's share price.
And I think that is a good thing
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No idea what is going on with him.
Potent antivirals targeting COVID-19 'direction of future,' Fauci
No. That is not stock manipulation.
Assuming "The 10Q is unavoidably due by 5:30PM" then the thing Leo has already decided is whether it is more advantageous to release the info before or after the close.
It is obvious Leo is "playing with his cards close to his chest"and I think this could signal Leo releasing the info after the close, forcing the shorts to cover overnight in the case of good news and reduce the number of "weak hands" who might sell, prematurely, on the expectation of bad news.
I think an after hour release of good/great info would also have a greater positive, effect on the IPIX's Tuesday (2/23) opening price than if the info was released before the close. Everyone will be on an equal footing, with 17 hours till market open, leaving investors an opportunity to peak behind the curtains and decide on the size of their contemplated IPIX investment and, hopefully, causing a stampede for IPIX stock at the Tuesday (2/23) open.
I've given a few reasons why Leo might wait till the last minute (after hours) to release good news, but Leo may have, yet, other reasons dictated by his strategy or external factors.
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If it was good news would YOU wait to tell it?
Covid-19 Vaccination Delays Could Bring More Virus Variants
I agree. I think Leo dropped the build-a-BP idea a long time ago.
I think Leo ultimately is looking for a buy-out, but not before he's developed the pipeline to the point where it will command a high buy-out price.
I expect that Leo will partner on a number of indications before actively seeking a buy-out. Having revenue generating drugs should also aid higher buy-out valuations.
I definitely don't expect a buy-out before Kevetrin is further developed. I think valuing "K" at this point would be difficult
IMO, a buy-out will come when Leo has positioned the company to command a valuation, though high, BP is willing to pay.
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My sense is that Leo is positioning for a buy-out. If he was 35 years old with a starter drug like Brilacidin I could see him building this into a major company, but the best way to make money in the next couple of years is a buyout. If investors want to stick around for everything else you keep your shares in whatever big pharma scoops this company up.
Was Russian Braggadocio EOY-2020 Corroborating Brilacidin Efficacy
Nice find. Here's another important point lost on those who think Leo should sell or accept a buy out for a few dollars a share:
No, the article does not state that.
Longpicker said:
"This article states that trials are presently on going."
The article said:
"Earlier this month IPIX began its Phase 2 clinical trial of Brilacidin for treating COVID-19."
https://microcapdaily.com/swift-rise-of-biotech-ipix-innovation-pharmaceuticals-as-potent-therapeutic-brilacidin-begins-clinical-trials/130534/
A future partner for B-ABSSSI?
Big Pharma-backed antibiotic R&D fund lands another $140M, bringing total haul above $1B [emphasis added]
by Nick Paul Taylor | Feb 19, 2021 8:35am
The AMR Action Fund has raised another $140 million to support antibiotic development. The cash adds to the almost $1 billion committed by around 20 biopharma companies, giving the fund the means to work toward its goal of helping up to four antibiotics to market by the end of the decade.
A who’s who of leading biopharma companies joined forces to set the fund up in July with the goal of saving the “collapsing antibiotic pipeline.” The $140 million in additional funding disclosed this week marks the first time AMR has secured money from outside the drug industry, although most of the fresh capital came from organizations adjacent to biopharma.
The Wellcome Trust, a U.K. health research nonprofit, provided around $67 million to the AMR fund. Most of the remaining cash came from the Boehringer Ingelheim Foundation, which committed $50 million. The European Investment Bank was the third, and smallest, investor.
Securing the funding gives AMR more than $1 billion to invest in antibiotic R&D. The fund is yet to disclose any investments—it only recently began operations—but has set out its investment policy. The plan is to invest in smaller biotechs with new antibiotics “that address the highest priority public health needs.”
In deciding which companies to back, the fund will draw on the input of an independent scientific advisory board and priority pathogen lists created by public health bodies. Novel antibacterial agents “with significant and differentiated clinical utility” that reduce patient mortality are a priority. The fund will invest across all stages of clinical development.
By committing more than $1 billion to such R&D programs, the fund aims to bring two to four new antibiotics to market by 2030. Some antibiotic products have made it to market in recent years. Last year, the FDA approved Shionogi’s Fetroja and Merck’s Recarbrio in new indications, while 2019 saw nods for a clutch of other drugs.
The commercial prospects of newly approved antibiotics are poor, though. After seeing biotechs go bankrupt after getting drugs to market, the AMR fund thinks investors are wary of funding late-phase development. Ultimately, reforms that create a viable antibiotic market may be needed to clear that bottleneck in the pipeline, but, until then, the action fund thinks it can improve the situation.
The fund disclosed the fresh funding alongside news that it has hired Henry Skinner, Ph.D., as its CEO. Skinner, formerly of Novartis, joins the fund from Tekla Capital, where he worked as senior vice president of venture.
https://www.fiercebiotech.com/biotech/big-pharma-backed-antibiotic-r-d-fund-lands-another-140m-bringing-total-haul-above-1b?mkt_tok=eyJpIjoiTnpKa09HRTJPVEUwTWpkayIsInQiOiJBWGx1dVlqaUwyajFvQ0lNRXJRU2EyeXRCTlF1NjF6U0NRYkpcL0p5XC9vZ0NuTk5mT3grb0hqaVhQXC9iUEJudzBWTVwvN2Nxejl2VHZBU1B2K3k0dDVOQWdacnZadGlLNnBvYzFxNDRWbkdjZjNyRGc0Z0I2Yk1WMnZrSTl0dXJjVVEifQ%3D%3D&mrkid=762402
From what I gather a regulatory filing containing info about the trials in Russia & U.S. and whose original release date was 2/16, will be filed 5 days later or 2/22 (Monday) since 2/21 is a Sunday.
A PR on Monday, 2/22 is expected in conjunction with this filing.
I hope you're right about today's close, but I think Friday's (2/19) close is the one to watch.
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The last hour could be interesting knowing that news can come in the morning. Been a nice steady rise so far today, bodes well for a rally into the close.
Way to go Leo. Let 'em know as little as possible, as late as possible.
IMO, NO NEWS IS GOOD NEWS
I feel very confident that the B-COVID trial is well underway and presumably started around Feb. 1 when their was roughly 100k hospitalized COVID patients in the U.S.
https://www.statista.com/chart/23477/number-of-people-hospitalized-with-coronavirus-in-the-us/?utm_campaign=acda4a8728-All_InfographTicker_daily_COM_AM_KW05_2021_Fr_COPY&utm_medium=email&utm_source=Statista%20Global&utm_term=0_afecd219f5-acda4a8728-306438441&fbclid=IwAR1e1o4T2NGjr4rpesmuISNWOWKLBPdBNf7x-twgGnh_j6y7d8XNRb4Ir3s
If my presumptions are correct then the B-COVID trial is different from any other 2020 COVID trial using hospitalized patients between 1/2020 and 11/2020, whose COVID hospital pop. maxxed-out at 60K, because B-COVID,at the PRESUMED trial start, had 40K MORE hospitalized patients available for recruitment nationwide.
I don't know if Leo's "radio silence" is due to external factors, internal factors or some combination of the two, but I think Leo understands that many of the same people who sought the company's demise are still in the environment.
This B-COVID trial is a phase 2 but, in terms of IPIX'S future, Leo might be looking at this as a "pivotal trial" and, just like the Atomic Bomb in WWII, all but a handful of stakeholders need to learn of its efficacy after-the-fact.
For B-COVID, the bar is low, but the stakes are high. Brilacidin has a resume that breeds confidence that this trial will not be its first failure.
Now it's time for Leo's detractors to note that this post looks like a fact-free zone. Guilty as charged. When short on facts I like to look at what I consider to be probabilities and I consider the B-COVID trial to have a high-probability of having started and showing high-efficacy with the low bar of remdesivir as the standard of care. This is what the evidence suggest.
Irrespective of whether this trial ends March 5, April 5, May 5, etc, this trial is expected to be a relatively short one. I hope Leo continue to execute his strategy and "hold his cards close to his chest" for as long as he deems necessary and I also hope he remembers that WWII mantra..."Loose lips, sink ships."
Lastly, I also hope, except for regulatory requirements, that we don't get a PR until after the trial. No NEWS IS Good News.
A very informative post that Leo has covered.
Without digging through PRs from 4-5-6- years ago, I remember a Leo/Bertolino PR where they talked about maximizing value for potential deals, which I remember as walking as many indications up to Phase 3 as possible.
Phase 3 is the most expensive phase and I believe Leo had already identified ending trials right before phase 3 as the point at which indications were most valuable since IPIX could not finance a phase 3 and was anticipating deal-making for an indication or the company.
IPIX's drug development chart seems to corroborate this:
http://www.ipharminc.com/stages-of-development
Litesout said: