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No clue. Not even sure what it is.
The answer will probably be in the next OTCMarkets report...if they EVER submit it. There hasn't been a report published since the one for the period ended 9/30/22.
"AIMRITE HOLDINGS CORPORATION COMPLETES JOINT VENTURE AND TERMINATES SHELL OR DEVELOPMENT STATUS"
News Provided By
Aimrite Holdings
March 27, 2023, 19:14 GMT
WooHoooo!
"I am going to talk to the company tomorrow and will write a post with a summary on everything." ....5/23
Did the dog eat your keyboard?
BTW, when you say "talk to the company" who speaks for them nowadays?
That little float must be locked up nicely by now. Strong hands! Know what you own!
(I got a million of em)
That's the third time you've mentioned that Company. What do they have to do with anything?
https://cosettepharma.com/newsroom/
They appear to be privately held.
"Cosette is backed by Avista Capital Partners, a healthcare focused private equity firm. "
"The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.
Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market."
"So why can IPIX not utilize the FDA Accelerated Approval Route "
As noted earlier the Company would have to identify a "surrogate endpoint" and meet it. The FDA expects a company to run a trial that confirms it.
I guess you didn't see it (appears I'm Ignored) but I asked earlier what you would propose that surrogate endpoint might be. Also, would you not expect the FDA to give some thought to and/or require some kind of commitment from the Company to run the required trial and an assurance that funding wouldn't be an issue?
It's not so easy, is it?
https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program
That was IPIX (formerly Cellceutix) news in 2014.....and Klebsiella was last mentioned in a filing in the 10-Q filed in November of 2016:
"In the Gram-negative program, our lead compounds are active in laboratory testing against some of the most problematic pathogens, such as Pseudomonas, Klebsiella, E. coli and Acinetobacter. We have compounds active against drug-susceptible strains as well as multi-drug resistant strains that produce Klebsiella pneumoniae carbapenamase (KPC). These are also called carbapenem-resistant Enterobacteriaceae (CRE)."
Here's what they say about the Gram-negative program in the most recent filing:
I don't think it's as easy as you make it sound:
https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program
What would the surrogate endpoints be in either case?
Maybe you'll find this interesting:
https://www.fda.gov/drugs/development-resources/table-surrogate-endpoints-were-basis-drug-approval-or-licensure
Shocking volume: $3,862. Something's up for sure.
"Bril disrupts the cell wall and this action coupled with fungistatic CAS make a fungicide."
So what's next?
It sounds like a clinical trial is the obvious next step. When I suggested earlier that that might be the case I was asked:
"What would motivate them (Merck) to combine it with Brilacidin to Kill the fungi and thus end the need for further treatment once the fungi has been eradicated?"
So if IPIX can't afford a trial and it's not in Merck's interest, what's next? How does this Company cash in on your "Bril disrupts the cell wall and this action coupled with fungistatic CAS make a fungicide" magic?
Or is this just another Dead End?
Is owning the rights to a compound the same as owning the compound itself?
https://www.sec.gov/Archives/edgar/data/1355250/000117152013000616/ex10-20.htm
Did IPIX pay Penn 10% of their upfront from Alfasigma?
"By focusing on the mortality numbers you ignored a number of significant complications of viral encephalitis plus you did not bother to mention the fact that Brilacidin has been shown to have activity against other viral disorders and other strains of encephalitis."
I didn't ignore anything.....I addressed the issues that I chose to address, just as you have.
"Below are some facts relating to Eastern equine encephalitis
No vaccine
No antiviral treatment
41% death rate
50% neurological complications such as: psychosis, memory loss,seizures"
Should there be a vaccine?
From your link: "In the United States, between six to eight cases are annually reported, predominantly between May through October, mostly in Florida, Georgia, Maryland, Wisconsin, and New Jersey"
Who would you give a vaccine to if one existed?
"No antiviral treatment" including brilacidin.
"41% death rate".
The very same paper says this: "The case-fatality rate described is 30%".
Which is it? The 11% of patients that did or didn't die would like to know.
But okay, I'll acknowledge that VEEV and EEV are very nasty and that they deserve a treatment. The same is true about ovarian cancer, head and neck cancer, psoriasis and ABSSSI....arguably those are not only more important in terms of healthcare but they are obviously much larger markets. IPIX hasn't shown the ability to develop drugs to safely and effectively treat any of those things. Why should the outcome be any different with these viruses or for that matter with the antifungal treatments that have been touted?
It has been over a year since CEO Leo sent a private, purportedly "unsolicited", email about the Payer Analysis regarding B-OM prior to making any public announcement about it. The fact that a firm was engaged to perform that analysis was revealed to the rest of the public about 6 weeks later (on 7/22/22).
The issue of compliance with Regulation Fair Disclosure notwithstanding, there has been nothing noteworthy put on the record since:
“This analysis reinforces Brilacidin’s potential to become a breakthrough OM treatment and commercialization success,” said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals."
There's that "p" word again.
How does any of that explain how market makers set this morning's share price?
In your own words, please.
Is this quote from a human being? If so, who? If it's from a publication, which publication?
"If the Phase 2b clinical trial for UP/UPS is successful, Alfasigma may apply for FDA approval for Brilacidin for this indication. If the Phase 2 clinical trial for oral mucositis is successful, Alfasigma may also apply for FDA approval for Brilacidin for this indication.
The development of Brilacidin is still in its early stages, but the drug has shown promise in clinical trials for a variety of indications. Alfasigma is actively developing Brilacidin and plans to start clinical trials for other indications in the near future.
Regulatory filings: Alfasigma is working with the FDA to file a New Drug Application (NDA) for Brilacidin for the treatment of UP/UPS. The company expects to file the NDA in the second half of 2023."
Some elements of it don't make sense and sound as if they were creative writings versus factual assertions.
Pardon my ignorance but I'm not familiar with Googles Bard AI. If that is the source, it should be made clear that it is mere fantasy, not warranting quotation marks.
"If I have time in the next day or two I can pull it."
I look forward to it but don't expect it.
To assure relevance the question that you're being asked is "How do market makers set the IPIX share price?" (even if "It applies to IPIX as it applies to all other companies").
"the pps is set by the Market Makers"
You keep saying that. How does that work exactly and how does it apply to IPIX??
"But the MMs have raised pps in the face of low volume/no demand situations, too."
News to me.
What they need to see...and what they have yet to see...is demand.
"The trading is low because informed IPIX investors are not about to sell imo. I continue to buy."
By that logic you must be buying from uninformed investors.
Yesterday's "good news" should have generated some interest from somebody. That was the point of my note regarding the lack of trading.
If buying pressure is met with a refusal of informed investors to sell, then how will the price ever rise?
Dollar volume $3,746. Why do you suppose that is?
200 shares traded since May15th.
"They do not dangle carrots."
No one said that the independent researchers did.
CEO Leo's the dangler.
Brilacidin's the carrot.
The researchers are just doing their jobs and doing what it takes to keep those jobs.
There are only 2 cents worth of IPIX investors with the strength left to keep chasing.......the rest have expired from exhaustion or recognized the folly of their ways.
Anyone who cares can see the reasons for the $.0181 share price right here, in the words of the Company itself:
https://www.sec.gov/cgi-bin/browse-edgar?company=innovation+pharmaceuticals&match=starts-with&filenum=&State=&Country=&SIC=&myowner=exclude&action=getcompany
"These conditions raise substantial doubt about our ability to continue as a going concern. Management’s plans include continuing to finance operations through the private or public placement of debt and/or equity securities and the reduction of expenditures. However, no assurance can be given at this time as to whether we will be able to achieve these objectives."
Tell me again....What Regeneron strategy is LE modeling IPIX after and how's it going so far?
The ONLY thing that IPIX and Regeneron have in common is a number of years of failure. That's a heck of a basis for using them as a model.
Name one other thing that they have in common.
Compare their managements and staffing. Compare their financing. During what time period did Regeneron lose 99% of its share price? At what point did Regeneron use up all of its cash?
Tell me again....What Regeneron strategy is LE modeling IPIX after and how's it going so far?
Researchers do research for a living or academic acknowledgment. Companies are supposed to SELL stuff.
Don't you ever get tired of the "potential", a word used 71 times here this year alone?
There's something oxymoronic about "independent scientists showing proof of Brilacidin potential". A thing's potential is only proven when it has been achieved and that hasn't happened.
"TO INSINUATE IT MUST BE HUGE SO IT WAS KEPT QUIET IS YOUR OWN THOUGHT GUESS.
I didn't insinuate that at all and the all caps approach does nothing to establish that I did. What are you reading?
"Is the CEO of the minority company (IPIX) allowed by the majority company (BEAMED) to give full details of the transaction to the public. One would think not necessarily, at least not a rule."
BeaMed could have signed a non-disclosure agreement with Shina. That wouldn't obviate IPIX's disclosure obligations. That said, LE has rarely needed a reason not to be transparent.
FWIW it's clear from the 10Q that there was no dilution of IPIX's ownership of BeaMed at the time of the BM/Shina agreement but that said there has been no disclosure of the terms of the agreement as to Shina's compensation for their input/efforts and you don't get sumthin for nuthin.
ps. What's this? "IDTAI OK!!"
"There is more new independent Brilacidin research almost every week. "
Sadly the other re word, revenue, is nowhere to be seen. If only Leo could pay himself (I almost said "the bills") with research.
This antibiotic/MRSA issue never fails to amaze me. These things have all been propounded here:
1. It's too expensive for IPIX to pursue.
2. There's not enough of a market for it.
3. No BPs appreciate brilacidin in spite of the trial results.
4. BP and the FDA have conspired against IPIX to assure that B won't be approved.
None of that stops you and others from singing B's antibiotic praises. Even the failure to take a single baby step forward with B-ABSSSI since 2016 doesn't seem to deter you. How do you address the 4 stumbling blocks, real and/or imagined, in order to find a way forward?
"maybe Shina does get a small slice of Beamed. Nobody really knows."
At the risk of stating the obvious, LE knows. The decision not to provide ANY level of detail about the deal speaks to his aversion towards transparency.
"BT BeaMedical Technologies (“BeaMed”), a private company developing a next-generation laser-based platform for epilepsy and cancer surgery, has notified Innovation Pharmaceuticals (OTC: IPIX) (the “Company”) that it has received U.S. Food and Drug Administration (FDA) clearance (K222701) for its MANTA surgical laser family."
They got a substantial equivalence determination.
What is a "clearance"? Is a substantial equivalence determination the same thing as a "clearance"?
"A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA). 510(k) (premarket notification) to FDA is required at least 90 days before marketing unless the device is exempt from 510(k) requirements."
It sounds as if the 90 day point was reached in February. Do you think that they have sold any Manta lasers since then or is that not even BeaMed's intent? Will this IPIX investment go without revenue until "The next approval (is) for the fiber optic delivery system and integration with MRI imaging" is achieved and those things can be manufactured and incorporated into a system with the me-too Manta?
"My guess is that approval could come within months."
And your guess as to when the first sale might occur?
Did Shina get a piece of BeaMed for their help with "immediate access to decades of experience and knowledge regarding design and implementation of high end medical imaging platforms" and "acceleration of our development timeline to get through FDA clearance and market launch quickly"?
The terms of the BeaMed/Shina deal haven't been provided (despite the IPIX public company ownership) but as the saying goes "You don't get something for nothing". IPIX investors should be asking that question given that BeaMed is being hailed as the Company's savior.
The "clearance" of Manta was very much a non-event, wasn't it? The laser with which it was deemed substantially equivalent received the same clearance in 2010.
https://www.accessdata.fda.gov/cdrh_docs/pdf22/K222701.pdf
https://fda.report/PMN/K100558
"In the Pipeline section of the IPIX website it shows Brilacidin at the Phase 3 stage for ABSSI and OM and Phase 2 stage for Covid and IBD"
That's some cockamamie table.
Contrary to your reading of it it accurately depicts B-ABSSSI as having completed Phase 2.
That's also true for B-OM but the Company shows it as having started Phase 3.
Covid is pictured being mid-Phase 2 but we all know that trial is done. Kaput.
The 10Q table says this about Inflammatory Bowel Disease (IBD):
IBD UC mid Phase 1
UP/UPS mid Phase 2
Both of those are inaccurate.
As to Fungal Diseases the website table doesn't say that B has to go through a Phase 1, it only says that it is currently in the preclinical stage.
"To me this is pure BS for in Fungal applications it will only be used stand alone or with current authorized FDA drugs."
Doesn't matter...he has successfully dangled another carrot. No point in sweating the details.
No mention of Karveer.....
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171662619
...or clinical testing in India.
I thought that was a big deal? In fact it is that deal that provides the ONLY basis for the multiple references to clinical stage testing in the PR. They can't say that "NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a clinical stage company" without Karveer, can they?
You would think it was worth mentioning. In fact it seems as if it is Karveer that is the clinical stage company and not NNVC.
"Personally, it looks to me like Covid is completely over for those that never had a Covid vaccine."
You mean the live ones, right? Because it has been over for some time for the others.
"all of their studies have produced stellar results."
If that's true then what does it say about the Company's failure to convert the science into revenue?
"Ipix and Mr. Ehrlich are not "going after the horse and donkey market".
No?
http://www.ipharminc.com/search?q=equine&f_collectionId=57ebc463f7e0abae9fb57b8f
Brilacidin, a Host Defense Peptide Mimetic, is a Broad-Spectrum Countermeasure Strategy Against Acutely Infectious Viruses
Carol Anderson1, Michael Barrera1, Niloufar Boghdeh1, Kyle Weston2, Jane Harness2, Aarthi Narayanan1
1 George Mason University; 2 Innovation Pharmaceuticals
https://static1.squarespace.com/static/5715352e20c647639137f992/t/63226423ad15bb3c77223340/1663198243904/MHSRS2022+-+Brilacidin+poster+fv.pdf
Not only did he suggest that B might be effective against donkeypox™ but he tied it into the drug's prospective effectiveness against CoVid:
"Staff scientists at the RBL will evaluate Brilacidin’s potential inhibitory efficacy against SARS-CoV-2 in lung epithelial cell lines, as well as its potential inhibitory effect in viral replication of the alphavirus (with Venezuelan Equine Encephalitis Virus [VEEV] as a prototype) in different cell lines."
He'd absolutely love it if people thought B was effective against ANYTHING. Doesn't take a mind reader.
"Merck currently has customers for life as their product, Caspofungin, doesn't kill the fungi but only prevents it from growing. What would motivate them to combine it with Brilacidin to Kill the fungi and thus end the need for further treatment once the fungi has been eradicated?"
They would be motivated by ending the desire for any other drug companies to develop a treatment.
"Would like to see IPIX spin off BeaMed into a separate company so that if IPIX goes belly up the current shareholders still have the investment of BM still available which should at the worst provide for full return of investment."
Can't be done. BeaMed isn't a subsidiary and can't be "spun off". The IPIX held shares can't even be transferred or sold without the permission of the BM board.
Adopted:
PLAN OF CONVERSION
OF
NANOVIRICIDES, INC.
A Nevada Corporation
INTO
NANOVIRICIDES, INC.
A Delaware Corporation
Also declared Effective:
S-3 Registration of $150,000,000
Common Stock
Preferred Stock
Debt Securities
Warrants
Units
Let's get this party started (again)!
What's AD up to this time?
"This 1 application, Aspergillus fumigatus, for Brilacidin + the Merck product Caspofungin, involves over 300 million cases a year per the UFRN article posted here today (based on the recent article that was published in Nature Communications) but then the same article says that it affects up to 5 million people per year. "
Read it again:
"Commonly known as mycoses, fungal diseases are constantly neglected because their potential harm seems unknown to most people. However, infections of this nature are responsible for 1.7 million deaths, with 300 million cases per year being reported worldwide. A pre-clinical research conducted in collaboration with UFRN presents an alternative for the treatment of Aspergillus fumigatus, one of the main pathogenic fungi for humans, causing a set of infectious diseases called aspergillosis, which can affect up to five million people annually."
The 5 million cases refers to Aspergillus fumigatus while the 300 million refers to ALL fungal infections.
Both numbers may be questionable:
"Due to the recent increase in the use of immunosuppressants to treat human illnesses, it is estimated that A. fumigatus may be responsible for over 600,000 deaths annually with a mortality rate between 25 and 90%"
https://en.wikipedia.org/wiki/Aspergillus_fumigatus
Every paper I've seen has a different set of numbers in it but they don't matter. B needs to show that it is a viable treatment in a clinical trial in human beings.
Here we go again:
" Brilacidine is already being tested in humans, in clinical phase 3, against skin infections caused by sensitive and multi-drug resistant bacteria in the United States. Studies show that it is also effective in vitro and in humans against SARS-CoV-2."
https://www.ufrn.br/en/press/features-and-knowledge/69808/nova-arma-contra-os-fungos
Ridiculous.
"Besides Rafael Wesley Bastos, the study was developed by Thaila Fernanda dos Reis, Patrícia Alves de Castro, Camila Figueiredo Pinzan and Gustavo H. Goldman, from the Faculty of Pharmaceutical Sciences of Ribeirão Preto (University of São Paulo); Pedro F. N. Souza, from the Department of Physiology and Pharmacology, Federal University of Ceará; Suzanne Ackloo, University of Toronto, Canada; Mohammad Anwar Hossain and David Harold Drewry, from the University of North Carolina at Chapel Hill; Sondus Alkhazraji and Ashraf S. Ibrahim, from the University of California at Los Angeles; Hyunil Jo and William F. de Grado, from the University of California at San Francisco; Jorge D. Lightfoot, Emily M. Adams, and Kevin K. Fuller, from the University of Oklahoma."
William F. de Grado knows full well that this is absolutely false....
"Brilacidine is already being tested in humans, in clinical phase 3, against skin infections caused by sensitive and multi-drug resistant bacteria in the United States"....
and that this isn't entirely true:
"Studies show that it is also effective in vitro and in humans against SARS-CoV-2."
One more time:
"Falsus in uno, falsus in omnibus is a Latin[2] maxim[3] meaning "false in one thing, false in everything".[4] At common law, it is the legal principle that a witness who testifies falsely about one matter is not credible to testify about any matter.[5] "
"I wonder how many of their parents got the covid shot."
I wonder how many of their parents had covid.
We don't have to wonder how effective brilacidin was in its Phase 2 covid trial and we don't have to wonder whether brilacidin has been approved for marketing and use in treating ANY illness.
And we don't have to wonder about the Company's share price/net working capital and cash position.
I wonder what's relevant to IPIX current/prospective shareholders and what isn't.