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Recent Pro and Con arguments:
Pro:
Brilacidin has never failed a clinical trial
(VERY TRUE...and Brilacidin is progressing from PHASE II TO PHASE III, on 3 different indications, UP, UC, and OM...in addition to waiting for results on B/Covid-19 PHASE II)
George Mason University’s Regional BioLab testing confirms stellar in vitro results of Brilacidin for Covid-19 and several other viruses
(VERY TRUE...and has proven out in those Lab TESTS...INDEPENDENTLY...that DeGrado's premise on Brillacidin's mechanisms...so far is CORRECT)
Received Fast Track Designation from FDA for PH II trial...
(VERY TRUE...FDA considered and reviewed the science and awarded FAST TRACK DESIGNATION as it ALSO believes in its ability of Brilacidin to prove the efficacy of referenced attributes)
Phase II International Trial results are expected at any time, with data lock any day now.
(VERY TRUE...TRIALS ARE COMPLETE...detail Data being supplied by supervising CRO from each site and reviewed and being entered by Data Service company on Software and screened for any missing data, if any...results generally take 6-8 weeks after last patient dosed...IPIX IS RIGHT ON COURSE!!!)
Brilacidin has shown three (3) MOAs in vitro to destroy Covid and has a selectivity index of 426
(VERY TRUE...INDEPENDENT GOV. TESTING WITH EXCELLENT RESULTS...Mulitple times safer than Remdesivir)
The company had about 10 million in the bank as of the last Q
(VERY TRUE...but could be less with the production of Brilacidin for UP AND OM Clinical Trials, as well as a formulation for UC and production)
Biden administration just announced plans to spend $11.2 Billion on the development of therapeutics
(VERY TRUE...and Dr. Kessler of UCSF in the thick of it...and connected with Dr. DeGrado of UCSG, Developer of Brilacidin and Scientific Advisor to IPIX!)
Con:
CEO Leo hasn’t updated any other Brilacidin indications
(Not TRUE...read the PRs over the past year...Somewhat True...if one expects updates every month...)
CEO hasn’t released BOD meeting notes
(True...but he is not required to)
CEO has neglected shareholder communications
(Not True...SOME INVESTORS COMPLIAN TOO MANY PRs ... for Some, its not enough...TRUTH is read the pages upon of PRs on IPIX web site... "enough" Communications depends upon if and when "material" news comes in Leo's possession for release!)
CEO is diluting for “lifestyle reasons”
(NOT TRUE... DILUTION FOR THE RAISING OF $13M to proceed on Clinical Trials for COVID-19 and production of Brilacidin for UP, UC and OM. )
CEO's is probably at a Club Med.
(NOT TRUE...likely in the Catskills ... but more likely glued to his desk coordinating all of the above.)
The CEO might be posting on stock boards under an assumed name
(VERY UNTRUE...IMO LEO DOES NOT EVEN READ THE BOARDS...and as a VERY PRUDENT CEO...would not even come close to doing anything that imprudent...WHY RISK HIS SHARES and INTEREST IN IPIX???? HE HAS THE POWER OF PR...anytime...and NO TIME TO WASTE READING WHAT POSTERS SLAP in posts...He apparently responds to rational emails sent to him...obviously, when and if time allows)
The company has only 3 employees, so cannot be taken seriously
(TRUE...to "3 employees" and FALSE...to "so cannot be taken seriously"... SO WHAT to the number of employees!... It's THE INTELLECTUAL PROPERTY AND WHAT HAS BEEN PROVEN OUT IN CLINICAL TRIALS...which is of VALUE!)
ONLY the INTELLECTUAL PROPERTIES (PRODUCTS) and CLINICAL TRIAL RESULTS creates value!....With successful trials BRILACIDIN and/or Kevertrin would have to be taken seriously ... for the purposes of Licensing to or Asset Sale of Brilacidin to BP... LEO HAS DONE AN EXCELLENT JOB in engaging THIRD PARTY CONTRACTORS in bringing B along in POSITIVE CLINICAL TRIALS (NO Failures) in all 3 Indications where it is now on the road to Phase III in all 3 ... AND
Receiving TOP-LINE RESULTS in BRILACIDIN/COVID-19 (with variants likely) in just completed CLINICAL TRIALS...COMBINED WITH IPIX'S PATENTS...ARE ALL THAT MATTERS.
IMO...Brilacidin ... "THE HOLY GRAIL" is about to get its WINGS!!!!
Know what you own!
Interesting...reading your own post...very consistent with your past ones...
To review the value of IPIX and to refute this statement posted:
The consequences of Censorship..."false conclusions" which always come out as "Lies"
Sudden Shift in COVID-19 Lab Leak Narrative ‘Mysterious’: Evolutionary Biologist
By Isabel van Brugen and Jan Jekielek July 2, 2021 Updated: July 3, 2021biggersmaller Print
The sudden shift in narrative over the possibility that COVID-19 could have emerged from a lab in Wuhan, China, is mysterious and is evidence of “just how corrupt our system has become,” according to evolutionary biologist Bret Weinstein.
Weinstein, biologist and co-host of the DarkHorse Podcast, has since last year explored the possibility that COVID-19 could have emerged from a laboratory. He told Epoch TV’s “American Thought Leaders” program (episode premiering on Sat. July 3) that the fact that the hypothesis is now receiving widespread recognition from the international community is “completely mysterious.”
“My channel was very early on this topic, and it was quite clear to many of us, starting with the tremendous coincidence of this virus having emerged first in Wuhan, where there is a biosafety level four lab studying these very viruses and enhancing them,” said Weinstein. “It was quite clear that there was at least a viable hypothesis that needed to be discussed.
Weinstein, a visiting fellow at the James Madison Program at Princeton University, said that before the narrative surrounding the COVID-19 lab leak theory gained traction, those who did discuss it were stigmatized, demonized and “portrayed as everything from racist to reactionary.”
“All we were doing was following the evidence,” Weinstein continued. “The change in that story was, I have to say, completely mysterious.”
While the theory that the virus was the result of a leak from the Wuhan Institute of Virology (WIV) was labeled a “conspiracy theory” last year, it has recently gained traction as a growing number of scientists and officials have lent credence to the hypothesis.
COVID-19, the disease caused by the CCP (Chinese Communist Party) virus, was first reported in the Chinese city of Wuhan.
A January State Department fact sheet raised questions about whether the outbreak could have been the result of a lab accident at WIV. It said the United States has “reason to believe” that several WIV researchers became sick with symptoms consistent with both COVID-19 and common seasonal illnesses in autumn 2019. The department also said the lab had been conducting secret military experiments on animals since at least 2017, and that it has a history of conducting gain-of-function research on viruses. Such research involves modifying viruses to have new or enhanced capabilities.
President Joe Biden on May 26 ordered the intelligence community to produce a report in 90 days on the origins of the virus, saying that intelligence agencies are looking at rival theories, including the possibility of a laboratory accident in China.
Weinstein criticized the explanations provided in recent weeks by “all of those who had gotten the story wrong” after the lab leak theory gained wider recognition.
PolitiFact, for example, on May 24 quietly retracted a September 2020 fact check that labeled a Hong Kong virologist’s claim that COVID-19 originated in a lab as inaccurate and a “debunked conspiracy theory.”
“The claim is inaccurate and ridiculous,” the now-archived fact check previously said. “We rate it Pants on Fire!”
In an updated editor’s note, PolitiFact explained why it removed the label.
“When this fact-check was first published in September 2020, PolitiFact’s sources included researchers who asserted the SARS-CoV-2 virus could not have been manipulated. That assertion is now more widely disputed,” the note said. “For that reason, we are removing this fact-check from our database pending a more thorough review. Currently, we consider the claim to be unsupported by evidence and in dispute.”
Separately, the Washington Post quietly walked back its claims regarding the COVID-19 lab leak theory.
The paper in February 2020 published an article claiming the idea was a “conspiracy theory” that had been “debunked.” The article attacked Sen. Tom Cotton (R-Ark.), who called for an investigation into the origins of the CCP virus.
Some reporters have said that they disregarded the lab leak theory because Republicans were largely the ones promoting the idea.
Weinstein described the phenomenon as “a headlong rush, by all of those who had gotten the story wrong to explain themselves—and their explanations made less than no sense.”
He said that certain journalists or media outlets “seemed to center on the fact that because [former President] Donald Trump had been favorable to the idea that this might have emerged from a lab, that that made it not true.”
“Which, of course, is such an illogical conclusion that it’s hard to imagine how anybody who considers himself a journalist could for a moment have been misled,” he continued. “I mean, at worst, if you thought everything that Donald Trump said was a lie—at worst, you would have to take it as no evidence either way.
“But that’s not how people treated it. They treated it almost as if the truth was always the opposite of what he said.”
Other outlets have also corrected or quietly updated stories, including Vox, while Facebook stopped banning posts suggesting the virus was man-made.
Weinstein said that he believes it eventually became “impossible to maintain the public lie that a laboratory version was somehow in conflict with the evidence.”
“And we now know from Dr. Fauci, his emails, that behind the scenes, the top people didn’t believe it either. They were just simply feeding the public a line that they had their own reasons for wanting the public to believe,” he said.
“I do have hope. But it is contingent on the several different stories that surround COVID revealing to us just how corrupt our system has become.”
Kfcyahoo...interesting observations regarding "protocol" and waiting times being used generally and specifically in current clinical just ended for Brilacidin/Covid-19...who is in control.
Great Post...Now people have to have to pay attention and absorb the "consequences" of the message, not ignore the dire consequences, and have the courage to voice it out loud, and disseminate what these enemies of America and Freedom are in fact attempting to do to this and every free country in the world.
TIME TO RISE UP!
Nice find... 1upandaway
To expand on and highlight the report:
https://www.insightaceanalytic.com/report/global-covid-19-therapeutics-market/1184
"
The increasing outbreak of covid-19 is increasing the demand for coronavirus vaccines or therapies, which will result in the expansion of the COVID-19 therapeutics market during the forecast period. According to the World Health Organization (WHO), globally, 175,847,347 confirmed cases of COVID-19, including 3,807,276 deaths, were reported to WHO as of 15 June 2021. Covid-19 cases are increasing day by day, and there is no officially approved drug for COVID-19.(YET) Many countries are facing a shortage of drugs likely to offer growth opportunities for pharmaceutical drug manufacturers. Leading market players are also developing innovative and efficient covid-19 drug therapies, resulting in overall market growth.
Major factors responsible for the growth of the COVID 19 therapeutic market are the fast adoption of advanced technologies, the growing number of corona patients, increasing healthcare expenditures, rising awareness about coronavirus, and increasing efforts by the pharmaceutical companies to develop covid-19 therapeutic drugs..."
The COVID-19 therapeutics market can be segmented on Infection Type, Drug Class, and Region. By Infection Type, the market can be divided into HCoV-229E, HCoV-OC43, SARS-CoV, New Haven CoV, HKU1-CoV, MERS-CoV, and Other Infection Types. SARS-CoV segment is expected to dominate the market as this virus is the main reason for the covid-19 outbreak. (ALL TARGETS OF BRILACIDIN) The market can be segmented into Monoclonal Antibodies, Antiviral, Anticoagulant, Glucocorticoid, Nitric oxide, and Other Drug Class in terms of Drug Class. The monoclonal Antibodies segment has dominated the COVID-19 therapeutics market. Regionally, the market is segmented into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. North America is expected to dominate the COVID-19 therapeutics market in the coming future.
"Some of the key Players of COVID-19 therapeutics market are Atea Pharmaceuticals, Inc., CytoDyn, Celltrion, Eli Lilly and Company, NRX Pharmaceuticals, Shanghai Junshi Biosciences Co., Ltd., Veru Inc., Humanigen, Inc., Catalent, Inc., Cipla Limited, Molecular Partners AG, Merck, Novartis International AG, Regeneron Pharmaceuticals, Inc., Vir Biotechnology, Revive Therapeutics Ltd., Brii Biosciences Limited, GlaxoSmithKline plc, APEIRON Biologics AG, Bristol Myers Squibb, Janssen Pharmaceuticals, Trevena Inc, Ono Pharmaceutical Co., Ltd., Constant Therapeutics LLC, Amarin Corporation plc, FUJIFILM Toyama Chemical Co., Ltd., NeuroBo Pharmaceuticals, Inc., Innovation Pharmaceuticals Inc., Bellerophon Therapeutics, Sorrento Therapeutics, PhaseBio, Pfizer, Takeda, BioAegis Therapeutics, Roivant Sciences, AI Therapeutics, Inc., Celltex Therapeutics, Blade Therapeutics, Marinomed Biotech AG, Synairgen, SAb Biotherapeutics, Romark Laboratories, L.C., Kiniksa Pharmaceuticals, UNION therapeutics A/S, Fulcrum Therapeutics, and Other Prominent Players."
Longs have to laugh at the disparaging comments waged at "The accountant" ... LEO has done an excellent job with IPIX in bringing forward Brilacidin as a "Leading Player" in developing innovative and efficient covid-19 drug therapy.
IMO we will soon begin to reap our rewards...from Leo's excellent shepherding of Brilacidin into a top Therapeutic contender...
As the review and articles below point out...Therapeutics will be necessary to control and eliminate Covid-19 and all of its current and future Variants.
https://uncoverdc.com/2021/08/23/nobel-laureate-warns-covid-vaccine-is-creating-variants/
https://www.totalhealth.co.uk/blog/are-people-getting-full-facts-covid-vaccine-risks
What you have pointed out here...
AMAZING...we learn so much from this board!
So you are saying it should be at $.60 right now:
1. Share price should miraculously rise...to $.60 NOW!
2. BEFORE phase II trial result!
3. SOLEY DUE TO THE SEVERITY OF THE PANDEMIC!
...I have to give credit where credit is due... COMPELLING REASONING!
OR... are you suggesting there is a problem because SP is not at $.60:
...simply due to "Severity to the pandemic"
I must say...I have to respectfully disagree with your logic and conclusions and dare to make the startling statement (ALL IMO OF COURSE):
SP will rise when TRIAL RESULTS are REPORTED (which I expect to be Stellar)... and SP will rise based upon not only the realization and discovery, that Brilacidin will destroy as a therapeutic...Covid-19 and ALL of its variants...but also WILL DESTROY a plethora of VIRUSES yet to be destroyed of effectively treated.
And, if as anticipated, the results are as expected by longs...we are not talking of $.60... but $6.00...then onto $60.00 as The Holy Grail proves out!
Of course...that surpassed your $2.50 projection by a wide margin. Hope you are not offended by the prediction, If so, I am sure you will get over it.
As pointed out a number of times...I can think of 12-20 investors who can "play with SP" on any given low-volume day.
THIS IS NOT ABOUT LEO (not a CEO beauty contest)...THE FACTS AND RESULTS FROM RBLs, recognition from the FDA with Fast track, trial authorization, etc, NEVER FAILING A CLINICAL TRIAL...(it has done what the scientist have predicted every time)and the Pedigree of DeGrado and his development of Brilacidin, as well as his USFC connection with Dr Kessler is all you need to focus on!
KNOW WHAT YOU OWN!
PS Hugan...you are advised to read my post slowly...and several times...we are not discussing $.60...but first $6.00!!! then onto to infinity (relatively speaking).
Agree: ..."$2.50-$6.00 is coming!"
Totally Disagree: "Ceo wouldn’t be dumb enough to have misled shareholders with so much Covid pumping over the last 18 months."
PROVING OUT DR. DEGRADO'S THESIS...ON BRILACIDIN's EFFICACY AGAINST ALL ENVELOPE VIRUSES (COVID-19 and ALL ITS VARIANTS)... IS NOT PUFFING!!!
In spite of slanderous and unfounded statements about Leo...he simply ignored the "noise" and moved forward to get to where we are today...
CEO (LEO) has been exceptionally cautious with PR's, not to PUFF but simply report facts...without superfluous commentary ... none of which apparently was criticized by the FDA to avoid C*CD fiasco.
IMO...Posters should (figuratively) "kiss Leo's butt" for what he has achieved ... being days away from proving out DeGrado's mechanism of action and demonstrating a high degree of efficacy against Covid-19... anticipated to be reported in DAYS...
Imputing Russian ability to Manipulate Data at Russian sites... is a "WELL DONE NOTHING BURGER". Otherwise, FDA would not have approved IPIX Trial protocol and site selection!
NOWHERE in the link below (PR) which was cited as relevant to the ownership of data issue, is the issue of "ownership of the data" addressed. Nor does the PR reveal that IPIX is either in control of or is the presenter of the data.
RBL's (example...GMU) are independent institutions (such as GMU, Rutgers, Duke, etc) that are authorized to conduct specialized research independently, and when contracted BY AGREEMENT or by GRANTS received from independent or governmental agencies...GMU is one of the NIAID-supported Biocontainment Laboratories from which it also receives $.
...meaning payment is made for their services...those who pay "own" the data...it is not public information unless and until the owner licenses or authorizes the data to be released into the public domain.
RBL's survive by Grants or Contract work...so far all work on Brilacidin has been independent of and funded by Grant monies...(with the exception below). There is no evidence that IPIX paid for the research peer-reviewed by GMU (except for a $34,000 study), nor is the research ongoing.
Therefore...there is no basis for imputing ownership of data to IPIX, and continuing to call for it as though IPIX is "hiding" information...beyond misleading...
THE PR CITED NOTES ONLY:
"...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"
and
In spite of harsh censorship by the MAINSTREAM PRESS AND MEDIA, ...(with strings being pulled IMO by the BP/FDA-CDC cabal)...Ivermectin has been shown in many legitimate studies outside U.S. as an effective tool at the inception of contracting Covid-19...
Ivermectin will be no threat to Brilacidin's financial opportunities... because of the DIRE NEED for Brilacidin's 3 mechanisms to save those who have moderate to severe Covid-19...
...IMO we will all learn VERY SHORTLY the extension of GMU Brilacidin test results reflected in the Clinical Trial results...at which point....the real fun begins...T
ps. Calls for DATA from the Military symposium are misleading...those who produced the data...OWN THE DATA...and IPIX...cannot release data without permission. The only exception is Data paid for by IPIX...and only limited to what they contracted for. GMU, Rutgers, and others studying Brilacidin OWN THE DATA and do not just give it away... it's proprietary to them (again, unless they wish to "give away" their work. (which work and data they use to get grants for themselves) ...
Truer words haven't been spoken...
Attila...you asked Barron the following question regarding his post:
Brad...IMO you are absolutely correct...some likely the beneficiaries of the Preferred Share conversion are attempting to get the best price (lowest) they can ...they have until August 15th to lower it or keep the lid on the 10-day average before the conversion date-time...
All the garbage being thrown at this board is total bullshit, and know this is not a reaction to the fundamentals...since THEY ARE LINED UP AND EXCELLENT POINTING TO SUCCESS OF BRILACIDIN.
Everyone on this board knows we are waiting for data aggregation (likely started last week as PR'd), scrubbing of data for computation and analysis...then reporting...by CRO, after data analysis done by a third party unaffiliated with the company.
NO ONE HAS A CLEAR OR HINT OF HOW BRILACIDIN ACTUALLY PERFORMED ON TRIALS...but IMO it leans heavily to SUCCESS,
therefore...it is clear that:
Leo cannot report anything...regarding the data or bottom line (nor can anyone else)
Leo can't pump stock...unless he wants IPIX to become C*CD
Leo is as transparent as he can and is permitted to be...
Reporting on data and results is IMPOSSIBLE at this time since NO ONE KNOWS THEM. Any comments or suggestions to the contrary are categorically false statements.
Meanwhile...the Preferred Shareholder and his MM (via a broker) will try to play with SP until August 15th...then IMO as a common shareholder look to lift SP.
Meanwhile, we will be closer, and closer to "TAKE-OFF" ... the Tribunal running this country and CDC...will be begging to take credit for a Therapy that is finally an effective killer of COVID and ALL ITS VARIANTS...
IMO I can see the "Scenario" of Kessler walking DeGrado/LEO into the FDA and CDC...then into the White House... where they discuss financial support for and roll-out of Brilacidin with the Tribunal, while Biden has his milk and cookies and plays "go-fish" with SS.
PS Hugon...IMO...a more likely Scenario...then you would think...more "alice in wonderland" to believe they do not know one another ...very well! and IMO enormous respect with it.
Rap...perhaps Loanranger would like to respond to your post...
regarding the availability to request Compassionate Use of Brilacidin?
In brief you noted that IPIX website outlines:
thefamilyman...
[
Lemoncat...
I agree with your previous post...Dr Farrell "shut the door" on the assertion that, Phosphlipidosis, would be an issue(reposted Farrel's post below).
We have much to look forward to in the immediate days ahead!
The phospholipidosis concern was thrown out in a post, and might have caught unsuspecting investors who might not "KNOW WHAT THEY OWN!" by suprise, and IMO could have brought on confusion and concern (which Farrell's post should have definitively buried).
There is and was no basis for questioning ... since a thorough Safety Review was already done on by an INDEPENDENT (SAFETY) MONITORING COMMITTEE...AND THE CLINICAL TRIAL WAS NOT STOPPED FOR ANY SAFETY ISSUES, INCLUDING phospholipidosis!
PJ's post below ... points that out.
Agree...to a point... it is only a "Good Post"...not a "GREAT POST"
"Great Post" is one full inclusive of ALL of Brilacidin's functionality and would more accurately state:
"If Brilacidin works, then the idea is to mass innoculate the Population with Brilacidin, as both a Prophylactic AND Anti-Viral (which property attributes demonstrated in GMU/RBL test results)...thereby covering (destroying) all COVID-19 and Variant variables (including the failed mRNA inoculations...i.e. breakout cases)."
...again...the full functionality ("If Brilacidin works")...is not being acknowledged in certain posts~
WHERE CAN COVID-19 go to multiply...if an effective THERAPEUTIC (BRILACIDIN) not only destroys the Virus on contact for the infected but destroys the virus on contact as it enters the potential victim's body (those who have not yet contracted it)?
IMO...THE ULTIMATE "HOLY GRAIL" for Destroying Covid-19 once and for all!
The quoted post below reflects a Huge BLIND SPOT...and simplistic and incomplete ASSESSMENT of BRILACIDIN's potential...
DaGreekster... your pointing out the "synergistic" activity between Brilacidin and Remdesivir...only alludes to part of the story between them.
DonnyBaseball516...when doing DD on Brilacidin (and IPIX)...you should "keep your eye on the ball!"
Consider IPIX's Scientific Advisor, Dr. William DeGrado... (who was one of the scientific co-discoverers of Brilacidin while a professor at the University of Pennsylvania, is NOW a renowned medicinal chemist and current faculty member at UCSF in the Department of Pharmaceutical Chemistry)... and his former company's (Polymedix) commentary on Brilacidin... when tested against a plethora of bacteria...has NEVER FAILED TO KILL A BACTERIA...(against which it was tested).
It ALSO appears to be true with all "Viruses" against which it has been tested so far!
"KEEPING YOUR EYE ON THE BALL"... IS KEEPING YOUR EYE ON " ENVELOPE" STRUCTURED VIRUSES AND BACTERIA...against which in all laboratories...(and clinical trials so far) BRILACIDIN IS AN IMMEDIATE & NATURAL BORN KILLER!
Now for the backstory...
WSJ: START-UP COOKS UP A BACTERIA SLAYER (JAN 2005)
http://www.wsj.com/articles/SB110487454326216811
Quote:
Full Story
A young Philadelphia company is aiming to develop an antibiotic drug that would kill bacteria once and for all. Researchers fight a continuing battle with bacteria, which adapt and eventually develop resistance to new antibiotics. Many of the world's bacterial infections become resistant to the drugs prescribed to fight them, and public-health advocates warn of a weakening pipeline of potentially life-saving antibiotics.
PolyMedix Inc., co-founded by University of Pennsylvania researchers, is targeting bacteria with synthetic molecules that mimic the activity of antimicrobial proteins that have a natural ability to prevent bacteria from developing resistance. "We believe that our antibiotic is unique," said PolyMedix President and Chief Executive Nick Landekic. The company believes it is the only one developing an antibiotic that uses synthetic molecules to mimic the mechanism of these "host defense proteins," which work by rupturing the skin of bacterial cells. "Our antibiotic directly breaks the bacteria cell membrane very much like a needle going into a balloon...and because of that there's a very low chance the bacteria can develop resistance to this," said Mr. Landekic, a pharmaceutical-industry veteran who helped form PolyMedix about 2½ years ago.
Conventional antibiotics must get inside the bacterial cell and target an enzyme, he explained. Bacteria develop resistance to such drugs by changing the target or simply pumping the antibiotic out of the bacterium, he said. PolyMedix says test-tube experiments demonstrate that bacteria don't develop resistance to the company's antibiotic, which works on infections in lab mice. The company believes it can start human clinical trials in a year if it secures the necessary financing.
PolyMedix... It has created 12 classes of antibiotics and selected several of them as candidates for human trials, Mr. Landekic said. "We've shown that they kill more than 80 different strains of bacteria. Actually, we haven't found any strain of bacteria that we haven't been able to kill with these compounds," Mr. Landekic said. The compounds have been effective on the biowarfare pathogens black plague, tularemia and 12 strains of anthrax, he said.
The question is repetitively asked here..."If Brilacidin is so great...why hasn't it been acquired by BP?" While it's been answered numerous times...I will try to assist those still questioning.
BEFORE NOW...(where we now have an enlightenment of the crisis to develop anti-bacterial and anti-virals) ...
...the economics were as stated:
Quote:
The valuation of Brilacidin suggested on this board ... at this point is a joke. With the successes pronounced by the GMU and to be made by "other" research institutes...the value based upon the "potential" has exponentially risen...just with COVID alone...
It is very difficult for anyone to assess, but I would not start at $5M as the base... The reference to assets sold in Bankruptcy (especially unknown) at 10 Cents on the Dollar, or even 1 Cent on the Dollar is no exaggeration. Considering over $100M was invested in Brilacidin and there were no negative tests results...ALL POSITIVE...and the fact that as LR pointed out...the true purchase in dollars was effectively 1/2 that... demonstrates how the Bankruptcy PP has no relevancy to the current valuation.
All investors know that the Valuation will be exponentially affected by the Covid Clinical Trial results...expected within 2-3 weeks.
MEANWHILE...it is worthwhile to review a 2005 post that outlined the backstory of Brilacidin, Polymedix and IPIX (formerly CTIX)
BRILACIDIN's KEY FUNCTION IS PIECING AND DESTROYING THE OUTER SHELL OF NOT ONLY ENVELOPE STRUCTURED BACTERIA, BUT LIKE STRUCTURED VIRUSES!... All viruses cited in the last PR are envelope structured viruses
________________________________________________________________________
slcimmuno Sunday, 02/01/15 04:50:34 PM
Re: None 0
Post #
90037
of 366695
Polymedix Supercomputing Backstory
Have posted on this before (e.g., the Landekic intvw)—how Polymedix came up with Brilacidin and related compounds via Uber-Supercomputing. The first two articles below, though, reveal just much brain (and processing) power--the Gee-Whiz factor--not to mention time (the years and years of development) and money (tens of millions I'd think though someone once posted it was north of $100m), went into what CTIX now has. DeGrado, Klein et al were simply far ahead of their times, by about a decade, with other researchers—IBM Research Labs, U of MD, Ohio State, U of Michigan—now playing catch-up (and w/o perhaps, well most probably, the equivalent brain/computer power).
I also added a WSJ article from 2005 that I hadn’t seen before. Some relevant stuff, including PolyCide applications.
NEW WEAPONS FOR THE GERM WARS: Inexpensive Polymers Can Extend the Range of Nature's Germ Fighter Arsenal (2002)
http://www.psc.edu/science/2002/klein/new_weapons_for_the_germ_wars.pdf
Excerpt
To solve this problem, Klein's team carried out a series of demanding quantum computations, an approach called density functional theory, to systematically derive accurate readings of the rotational resistance of the arylamide backbone. With about 60,000 hours of computing time using 128 LeMieux processors, they derived the force fields they needed.
SCALABILITY/TECHNICAL COMPUTING (2003)
Pittsburgh Supercomputing Center
Pittsburgh, PA
United States
Year: 2003
Status: Finalist
Category: Science
Nominating Company: Hewlett-Packard Company
Summary: Massive computing power accelerates the search for inexpensive polymers that would function the same way as simple but difficult-to-manufacture peptides that are known to be powerful anti-bacterials and that can reduce the incidence of in hospital infection.
http://www.cwhonors.org/Search/his_4a_detail.asp?id=4849
Excerpt
Prior to LeMieux becoming available (early 2002), there was no similarly powerful system available to researchers in the United States outside of a few installations at classified government laboratory facilities. LeMieux thus filled a large gap in United States research capability -- highlighted in a 1999 report to President Clinton (The President’s Information Technology Advisory Committee report). When installed, LeMieux’s 3,000 parallel processors, capable of six teraflops peak performance (six trillion calculations a second), provided more than five times more computing capability than the next most powerful system available to researchers through the National Science Foundation. It has facilitated, and will continue to facilitate, progress in many areas of significant social impact, such as the structure and dynamics of proteins useful in drug design, storm-scale weather forecasting, earthquake modeling, and modeling of global climate change.
WSJ: START-UP COOKS UP A BACTERIA SLAYER (JAN 2005)
http://www.wsj.com/articles/SB110487454326216811
Full Story
A young Philadelphia company is aiming to develop an antibiotic drug that would kill bacteria once and for all. Researchers fight a continuing battle with bacteria, which adapt and eventually develop resistance to new antibiotics. Many of the world's bacterial infections become resistant to the drugs prescribed to fight them, and public-health advocates warn of a weakening pipeline of potentially life-saving antibiotics.
PolyMedix Inc., co-founded by University of Pennsylvania researchers, is targeting bacteria with synthetic molecules that mimic the activity of antimicrobial proteins that have a natural ability to prevent bacteria from developing resistance. "We believe that our antibiotic is unique," said PolyMedix President and Chief Executive Nick Landekic. The company believes it is the only one developing an antibiotic that uses synthetic molecules to mimic the mechanism of these "host defense proteins," which work by rupturing the skin of bacterial cells. "Our antibiotic directly breaks the bacteria cell membrane very much like a needle going into a balloon...and because of that there's a very low chance the bacteria can develop resistance to this," said Mr. Landekic, a pharmaceutical-industry veteran who helped form PolyMedix about 2½ years ago.
Conventional antibiotics must get inside the bacterial cell and target an enzyme, he explained. Bacteria develop resistance to such drugs by changing the target or simply pumping the antibiotic out of the bacterium, he said. PolyMedix says test-tube experiments demonstrate that bacteria don't develop resistance to the company's antibiotic, which works on infections in lab mice. The company believes it can start human clinical trials in a year if it secures the necessary financing.
PolyMedix says it identified its lead drug candidate in less than 18 months for less than $2 million. The company believes it can have its first antibiotic drug on the market in five to six years, for about $100 million. It has created 12 classes of antibiotics and selected several of them as candidates for human trials, Mr. Landekic said. "We've shown that they kill more than 80 different strains of bacteria. Actually, we haven't found any strain of bacteria that we haven't been able to kill with these compounds," Mr. Landekic said. The compounds have been effective on the biowarfare pathogens black plague, tularemia and 12 strains of anthrax, he said.
PolyMedix has raised more than $6 million from so-called angel investors -- wealthy individuals who advise start-up companies at their earliest stage -- and plans to seek $20 million to $25 million more from institutional investors this spring, with Legg Mason Inc. acting as its financial adviser, Mr. Landekic said. The university and the founding researchers have equity stakes in the business.
Assuming it gains the financing, the company hopes to file an investigative-new-drug application for its lead antibiotic with the Food and Drug Administration in December 2005 and would start clinical trials soon thereafter. The company, which says the world-wide market for antimicrobial drugs exceeds $30 billion, plans to first develop its antibiotic as an intravenous treatment, followed by oral and topical formulations. "This drug has multibillion-dollar sales potential and the opportunity to become the standard of care for hospital infections," the company says in an investor presentation. "Oral formulations have the potential to become the agent of choice in outpatient care of infections."
PolyMedix also will seek FDA approval for a sanitizing polymer hand lotion for doctors and nurses that it expects will prevent bacterial resistance, using the same protein-mimicking mechanism.
The U.S. Centers for Disease Control and Prevention in Atlanta has launched a campaign against antimicrobial resistance in hospitals, where, it says, nearly two million patients contract infections each year, and roughly 90,000 die as a result. More than 70% of bacteria that cause hospital-acquired infections are resistant to at least one of the drugs commonly used to treat them, the CDC says.
PolyMedix is weighing other polymer-based antimicrobial products, such as additives that could give paints, plastics and fabrics self-sterilizing surfaces. The company envisions licensing the technology for use in such products as bandages, catheters, food-preparation surfaces, toilet seats and uniforms, and is talking with many companies, Mr. Landekic said. For the drugs, PolyMedix aims to retain North American rights and license rights for the rest of the world to others. It has spoken with some pharmaceutical companies, he said.
Other researchers have developed drugs directly from proteins or smaller peptides -- chains of amino acids, the building blocks of life -- but protein-based drugs can be difficult and expensive to make and can't be taken orally. "We attempted to understand the molecular and biophysical basis for the action and then made molecules that are much smaller and much easier and cheaper to prepare," said William DeGrado, a professor of biochemistry and biophysics at the University of Pennsylvania's medical school, who is a PolyMedix co-founder and a member of its scientific advisory board.
Michael Zasloff, senior life-sciences analyst for Ferris Baker Watts and a professor at Georgetown University School of Medicine, said the implications of PolyMedix's technology are broad. "They've created a new class of antimicrobial substances, merging the design principles of polymers with the antibiotic or antimicrobial killing properties of some of nature's most potent anti-infectives," said Mr. Zasloff, who discovered an antimicrobial peptide he named magainin, from the Hebrew for shield, in the skin of a frog.
It is the mechanism of magainin-like proteins that PolyMedix is mimicking through synthetic molecules. If PolyMedix's antibiotics prove effective in oral form, "then they would have enormous potential," said Mr. Zasloff, who isn't involved with the company. Even if there were problems with the drugs, he said, PolyMedix may find broad applications for its synthetic antimicrobial molecules in other products.
It appears a more "surgical delivery" is being developed via Capsule since within a capsule many time-released nodes with release occurring at different times and locations can be achieved...
Specific vendors and methodology would also be considered proprietary and valuable information to the competition...therefore IMO it would be wise and should not be specifically divulged publically...
Also...IMO If you are correct..."Discontinuing" TABLET delivery because of a "preferred" CAPSULE mode of delivery"...could be very well suggested and informally directed by a particular BP interested and working in the same indication.
So "switching" vs. "discontinued" which was used by a researcher (who likely supplied info for the article, who might have contacted Oralogik and learned of the discontinuance...of Tablet...but then erroneously concluded UC was "dropped")...when the researcher failed to verify if IPIX/Brilacidin-UC development was continuing (AS PER PR) with a more targeted and optimum mode of delivery...the "Capsul" ...
AND PERHAPS...it was all done at the suggestion of and in informal collaboration with a third party BP experienced in such delivery for UC...
If I am correct, "Who might that BP be???" That is the question!
That is the more interesting musing.
IMO...We were likely told only what we needed to be told, via the PR.
Just4Profit...obviously TD Ameritrade is CORRECT...IPIX is not on the Restricted List...
The post that said it was and included because is it a microcap stock list on a spreadsheet was OBVIOUSLY BLATANTLY FALSE...total BS.
The spreadsheet attached that post identified... those stocks as "US_MICROCAPS"...not as stocks subject to Rule 15c2-11 Delisting... because IT ISN'T
In fact the TD AMERITRADE LIST ...
( https://www.scribd.com/document/515832618/Tda-101550 ) is Additional evidence that...IPIX is not on the Restricted List...for 2 reasons:
COMPANIES ON THIS LIST ARE not subject to rule Rule 15c2-11 UNLESS...the company is "NON-REPORTING" or a "SHELL COMPANY"...which IPIX is neither...
IPIX is clearly a "REPORTING" and an ongoing operating business, "NOT A SHELL" company...
Alluding to stocks on a GENERAL LIST OF MICROCAP (including, OTC, NASDAQ, and AMEX)...as being "restricted" is totally false, and the list as such is total meaningless regarding Rule 15c2-11...
...and is pure FUD!!!
Read the article...before commenting and prove it incorrect...
https://helix.northwestern.edu/article/thalidomide-tragedy-lessons-drug-safety-and-regulation
"In a post-war era when sleeplessness was prevalent, thalidomide was marketed to a world hooked on tranquilizers and sleeping pills. At the time, one out of seven Americans took them regularly. The demand for sedatives was even higher in some European markets, and the presumed safety of thalidomide, the only non-barbiturate sedative known at the time, gave the drug massive appeal. Sadly, tragedy followed its release, catalyzing the beginnings of the rigorous drug approval and monitoring systems in place at the United States Food and Drug Administration (FDA) today."
The dire need for Brilacidin...to possibly avoid another "Thalidomide-like" tragedy...
crasho...
Regarding this post:
Of course, after a successful trial... Brilacidin will not be in demand as an alternative to promoted experimental vaccines...because
(tongue in cheek)
NOTHING TO SEE HERE!
There are two camps on the current Vaccines being "offered"
Advocates of mRNA & J&J...protest:
1. They know the science and these vaccines are infinitely safer than keeping one's immune system strong and toughing it out, and taking drugs off label which they dispute...appear to act as prophylactic and very early stage cure
2. Anyone who disagrees with them ... needs to be, lives destroyed, put down like a dog. ... a good old CCP approach to imposing their views.
3. NOTHING TO SEE HERE!... "Question us, and you are a "C" theorist!!!
Advocates of Caution and on FULL Public Disclosure and Review...and protest:
1. The deleterious (SAE) effects and damage by the vaccines (especially to those under 18) are prohibited from being discussed...
2. Those who address the scientific evidence and issues are to be terminated from social media and discussions of dangers are actively suppressed (i.e. "C......d"
3. Those who question ask:...Why are we "C......d" and you afraid of refuting out proof!
TODAY...another report...this time J&J...(also on CNBC)
https://www.westernjournal.com/fda-warn-covid-vaccine-link-rare-nerve-disorder-can-cause-paralysis/?ff_source=Email&ff_medium=WJBreaking&ff_campaign=breaking&ff_content=western-journal
"BUT of course, NOTHING TO SEE HERE!!! Shut up and TAKE IT ... or we will force it in you!"
IMO...Brilacidin will be a big part of the answer...especially in a spray!
OUT TODAY:
The above stock photo shows a woman getting vaccinated.
The above stock photo shows a woman getting vaccinated. (Marko Geber / Getty Images)
FDA to Warn of COVID Vaccine Link to Rare Nerve Disorder That Can Cause Paralysis
Jack Davis
July 12, 2021 at 4:12pm
The Food and Drug Administration is adding a new warning for Americans who get the Johnson & Johnson coronavirus vaccine based on reports of a rare nerve disease in those who received the shots.
“Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination,” the FDA said in a letter dated Monday to Janssen Biotech, the division of Johnson & Johnson that developed the vaccine.
About 100 preliminary reports of Guillain-Barré have been reported, according to the Centers for Disease Control and Prevention, The Washington Post reported.
Of those, 95 were serious and required the patient to be hospitalized, the FDA said. One person has died.
The FDA will stop short of saying the vaccine caused the disease.
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Existing evidence “is insufficient to establish a causal relationship,” the FDA said, according to The Post.
The FDA said it “continues to find the known and potential benefits clearly outweigh the known and potential risks” of the Johnson & Johnson vaccine.
In its reporting, The New York Times said that incidence of the rare nerve disorder “appear to be three to five times higher among recipients of the Johnson & Johnson vaccine than among the general population in the United States.”
According to the FDA letter sent to Janssen, “Guillain Barré syndrome (a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis) has occurred in some people who have received the Janssen COVID-19 Vaccine. In most of these people, symptoms began within 42 days following receipt of the Janssen COVID-19 Vaccine. “
The FDA said symptoms of having Guillain-Barré include weakness or tingling sensations, especially in the legs or arms; difficulty walking or with facial movements; and difficulty with bladder control or bowel functions.
Related: CDC Says Kids Should Wear Masks in Schools Unless Fully Vaccinated
Most of those affected have been men aged 50 and older, according to the CDC.
The Post report said no such issues have been found with the Pfizer-BioNTech and Moderna vaccines.
This is the second major stumbling block for the Johnson & Johnson vaccine.
Three months ago, it was put on pause amid concerns the vaccine caused severe blood clots. The pause in its use ended after a warning was attached to the drug.
The Astra Zeneca vaccine, which is given in Europe and has not been approved for use in the U.S., has also been examined for a possible link to Guillain Barré.
Worth Posting in full below:
Neither Wienstein, nor Malone are anti-vaccine, but the extreme censoring of both Dr Bret Weinstein and Dr Robert Malone (who is attributed with the founding of the mRNA vaccine platform) ... speaks volumes on the concern they express about Moderna and PFE mRNA vaccines and suppression of discussion of use of Ivermectin for limiting very early stages consequences of or prophylactic use for preventing Covid-19.
The "suppression" and "censorship" of any discussion, which cannot be had, unless it is the official FDA/CDC versions...is beyond "Alarming"...and it should be to anyone who claims to be a "scientist."
Those who suppress...obviously cannot support their positions, or cannot refute those expressing the opposite. AND IMO THAT IS DANGEROUS, especially when they are attempting to inject it into the arms of Children!
________________________________________________________________________
Single most qualified' mRNA expert speaks about vaccine risks after he says YouTube banned his video
Lawrence Richard
June 24, 2021·3 min read
The man who invented the mRNA technology used in some coronavirus vaccines says he was censored by YouTube for sharing his concerns on the vaccines in a podcast.
"[O]ne of my concerns are that the government is not being transparent with us about what those risks are. And so, I'm of the opinion that people have the right to decide whether to accept a vaccine or not, especially since these are experimental vaccines," said Dr. Robert Malone during a Wednesday segment on Fox News's Tucker Carlson Tonight, saying YouTube deleted a video of him speaking about the associated risks.
Opening the segment, Carlson shared some studies showing heart inflammation and death correlating with the use of the vaccines.
"A Norwegian study conducted of 100 nursing home residents who died after receiving Pfizer's corona shots. They found that at least 10 of those deaths were likely caused by the vaccine. 10%," Carlson said.
JOHN MCAFEE FOUND DEAD IN SPANISH PRISON CELL
"Young adults in the prime of their lives are being forced to take the vaccine because Tony Fauci said that," he said, contending Malone’s expertise makes him "the single most qualified" person to share information about the technology and warrants him "a right to speak."
Malone clarified that he was not discouraging the use of the vaccine but was providing people with as much fair information as he could about their risks.
"This is a fundamental right having to do with clinical research ethics," he said. "And so, my concern is that I know that there are risks. But we don't have access to the data, and the data haven't been captured rigorously enough so that we can accurately assess those risks — and therefore … we don't really have the information that we need to make a reasonable decision."
CLICK HERE TO READ MORE FROM THE WASHINGTON EXAMINER
"That's one of my other objections, is that we toss about these words, risk-benefit analysis, casually as if it's a very deep science. It's not. Normally, at this stage, the CDC [Advisory Committee on Immunization Practices] would have performed those risk-benefit analyses. They would be data-based and science-based. They're not right now," Malone said.
Malone also said he has "a bias that the benefits probably don't outweigh the risks" for younger people who are being encouraged or required to take the vaccine.
"I can say that the risk-benefit ratio for those 18 and below doesn't justify vaccines, and there's a pretty good chance that it doesn't justify vaccination in these very young adults," he added.
Malone discovered in-vitro and in-vivo RNA transfection when he was at the Salk Institute in 1988, and he subsequently invented mRNA vaccines, which are being used over 20 years later to combat the spread of the coronavirus.
YouTube told the Washington Examiner of the video that while it is "open [to] discussions of potential treatments and clinical trials related to COVID-19 on YouTube, based on guidance from the CDC, FDA and other local health authorities, we don’t currently allow content that recommends Ivermectin as an effective treatment or prevention method for the virus."
"As such, we removed content from Bret Weinstein's channels that violated this policy. We craft our policies to prevent the risk of egregious real-world harm, and update them as official guidance evolves. We do allow exceptions to our policy about Ivermectin, including content that also gives viewers the full context of the FDA’s current position."9.
Hi Cowtown...
No doubt it's come a long way...but it only addresses one symptom 0f the infection, albeit an important one (focused on preventing and treating an immune hyper-response called ‘cytokine storm’). I could see its EUA in a cocktail...supplementing a therapeutic which would be an antiviral, anti-inflammatory, and anti-bacterial...if you get my gist. GLTA
Insightful post...I'm not an investor, i.e. not long or short, but simply observing... and wondering why mgt would not be more forthcoming with its communication (as you noted it could have been). Too bad for those who did jump in on the "news". Of course, ultimately they could recoup their losses from jumping in at yesterday pre-market/high if EUA is granted in EU or US. But, I am not a fan of that type of PR. (an unnecessary sneaky phrasing to pump). Instead of that PR inducing me to take a position, it has become a red flag for caution but will continue to watch. GLTA.
STATEMENT MADE:
EIDD-2801, as Covid-19 therapy raises more questions than it answers...from a safety profile, specifically toxicity and mutation causing attributes!
Right from one of the articles you posted...
1. An Emory University program (Drive)developed the drug (George Painter)...who is now a "consultant" to Ridgeback
2. They could not give EIDD-2801 away, until Holman as a consultant to his Wife... the single owner of Ridgeback funded the purchase of patents from Emory.
3. "According to Bright’s account, when he told the group his reservations, Painter “insisted that EIDD-2801 could be a great asset to American national security and warned that if BARDA did not fund its manufacturing immediately, Emory would take the drug to another country to manufacture it.” " INTERESTING LEVERAGING OF FOREIGN COUNTRY INTEREST!...Hello Russia?
4. FLY IN THE OINTMENT!... IS ANYONE INTERESTED IN GROWING ANOTHER ARM?
EIDD-2801... has high toxicity and highly mutagenicity
"Raymond Schinazi, an Emory University chemist who has extensively studied the active ingredient in EIDD-2801 but has no connection to DRIVE, notes that his former pharmaceutical company, Pharmasset, abandoned it in 2003 after discovering its mutagenic properties. Schinazi says the small chemical tweaks made to increase the ingredient’s bioavailability and transform it into EIDD-2801 are unlikely to change its mutagenicity. “Thank goodness someone is raising the red flag,” about EIDD-2801, Schinazi says. “You don’t develop a drug that’s mutagenic. Period.”
5. NOTHING TO SEE HERE!" ???
"Toxicity studies with EIDD-2801 have taken place in mice, rats, dogs, and nonhuman primates" (...TEETH MISSING, SKULLS PARTIALLY FORMED...)"Painter says, and the results have been shared with FDA and drug regulators in Europe."
6. How much credence will be given to this drug with FDA "EUA"..." it's safe"? How much MUTATION tolerance is the POTENTIAL RECIPIENTS of these drugs willing to take?...
"Denison, who is also a clinician, notes that some mutagenic drugs have come to market—and that weighing their risks versus their benefits depends on the dose, frequency of use, and the severity of the disease.
(THAT'S COMFORTING!) Ribavirin, for example, has been used to treat hepatitis C, Lassa fever, and other viral diseases despite mutagenic properties severe enough that regulators advise women who are pregnant or considering pregnancy, or men whose partners are considering a baby, to not take it. For EIDD-2801 as a treatment of COVID-19, Denison says,
“We’re talking about a short-term use to potentially treat or prevent disease.” Schinazi counters that reproductive harm could still happen with short-term treatment, and using the drug to prevent disease—a hoped-for use of other experimental COVID-19 drugs—might lead to far more exposure."
BOTTOM LINE... it is comical and sad that those who allege "expertise" still deny the toxicity of the "Spike Protein" from the mRNA vaccines...and SAE not formally recorded for Remdesivir. (liver toxicity)
IMO...ITS ALL ABOUT "Uninformed Consent"...NOT INFORMED CONSENT!
EUA not = SAFE, it is "We (FDA/CDC) have decided that some Recipients can take bodily damage or death...to be politically expedited...and appear as though we have this pandemic under control"...SO WE LIE.
Standard: “We’re talking about a short-term use (with damage or death to some) to potentially treat or prevent disease.”
https://www.sciencemag.org/news/2020/05/emails-offer-look-whistleblower-charges-cronyism-behind-potential-covid-19-drug
"In November 2019, the whistleblower complaint says, Bright met with Emory University chemist George Painter, who is the CEO of Drug Innovation Ventures at Emory (DRIVE), a nonprofit owned by the university that is developing EIDD-2801. Painter brought a consultant with him, John Clerici, a lawyer. Clerici formerly worked as a registered lobbyist for Chimerix, a company previously led by Painter that received $72 million from BARDA to develop a smallpox drug. A biography posted by Clerici’s current law firm says he specializes in biodefense and “has assisted more than three dozen companies in obtaining over four billion dollars in funding for the research, development, and procurement of public health countermeasures.” Bright’s complaint describes Painter as a “longtime friend of” Kadlec’s and says Clerici had “a long-standing connection to” him.
According to the complaint, Painter and Clerici presented EIDD-2801 (EIDD stands for Emory Institute for Drug Development) as a viral “cure-all” and “miracle cure.” Bright, concerned that evaluation of its safety in people had not yet been done, says he pushed back against pressure from Painter, Clerici, and Kadlec to fund EIDD’s development for an unspecified amount. He says he was also reluctant because Emory had already received a total of $26 million from NIH and the Department of Defense to advance the drug. Bright’s complaint says he believed BARDA should wait to see some results from a human safety trial “to make an informed decision based on scientific data.”
According to Bright’s account, when he told the group his reservations, Painter “insisted that EIDD-2801 could be a great asset to American national security and warned that if BARDA did not fund its manufacturing immediately, Emory would take the drug to another country to manufacture it.” Despite Bright’s concerns, according to the complaint, late last year Kadlec “made it clear that he intended to push the funding through for this contract.”
Painter says the November meeting with BARDA was arranged through “normal channels” and was for “just a little bit of money” to help develop a protocol to submit to regulators to conduct human studies. He also says he never referred to EIDD-2801 as a cure-all or miracle cure and he is “rather taken aback” by Bright’s complaint. “I just feel like collateral damage in a battle,” says Painter, who adds that he has known Kadlec for years but doesn’t consider him a friend. Clerici calls Bright’s complaints “politically motivated allegations,” adding “I unequivocally deny the reckless insinuations in Dr. Bright’s complaint.”
In late 2019, according to the complaint, Kadlec called a meeting to discuss the request for EIDD-2801 funding, and Bright reiterated his reservations. “Dr. Kadlec let it be known he was very unhappy with Dr. Bright’s position on this issue,” it stated.
Two months later, Painter and Clerici contacted the head of ASPR Next—which the complaint describes as an “opaque funding program” separate from BARDA—for EIDD-2801 funding. They now billed the broad-spectrum antiviral as a possible COVID-19 treatment. Bright by then had set up a task force to speed BARDA funding requests for the rapidly spreading disease. “Dr. Painter and Mr. Clerici were deliberately circumventing the [task force] submissions process,” the complaint asserts.
Painter categorically denies this allegation. “I don’t know what [Bright’s] referring to,” he says. “I don’t have a dog in this fight. I just wish that things were better controlled under the circumstances where there are a lot of people dying.”
In March, a study published on the preprint server bioRxiv showed that EIDD-2801 could cripple SARS-CoV-2, the RNA virus that causes COVID-19, in human cells. “It was profoundly active against the virus,” says Mark Denison, a virologist at Vanderbilt University Medical Center who co-authored the study. (It was published on 29 April in Science Translational Medicine.)
Also in March, DRIVE found a new partner in Ridgeback, a small, privately held company founded by husband and wife Wayne Holman and Wendy Commins Holman, that is best known to infectious disease scientists for licensing an experimental monoclonal antibody that worked well against the Ebola virus in a clinical trial. (That treatment was developed by the National Institute of Allergy and Infectious Diseases.) Ridgeback purchased an exclusive license to EIDD-2801 from DRIVE for an undisclosed amount.
Raymond Schinazi, an Emory University chemist who has extensively studied the active ingredient in EIDD-2801 but has no connection to DRIVE, notes that his former pharmaceutical company, Pharmasset, abandoned it in 2003 after discovering its mutagenic properties. Schinazi says the small chemical tweaks made to increase the ingredient’s bioavailability and transform it into EIDD-2801 are unlikely to change its mutagenicity. “Thank goodness someone is raising the red flag,” about EIDD-2801, Schinazi says. “You don’t develop a drug that’s mutagenic. Period.”
Toxicity studies with EIDD-2801 have taken place in mice, rats, dogs, and nonhuman primates, Painter says, and the results have been shared with FDA and drug regulators in Europe. “We haven’t seen robust evidence for any sort of mutagenicity as had been seen in the past [by Schinazi and others],” Painter says, noting that regulators gave them approval to conduct phase I studies of the drug in healthy humans. DRIVE and Ridgeback, which is sponsoring the clinical trials, plan to do “more rigorous analyses,” including reproductive studies in animals, Painter says. “We’ve been very, very, very thorough.”
Denison, who is also a clinician, notes that some mutagenic drugs have come to market—and that weighing their risks versus their benefits depends on dose, frequency of use, and the severity of the disease. Ribavirin, for example, has been used to treat hepatitis C, Lassa fever, and other viral diseases despite mutagenic properties severe enough that regulators advise women who are pregnant or considering pregnancy, or men whose partners are considering a baby, to not take it. For EIDD-2801 as a treatment of COVID-19, Denison says, “We’re talking about a short-term use to potentially treat or prevent disease.” Schinazi counters that reproductive harm could still happen with short-term treatment, and using the drug to prevent disease—a hoped-for use of other experimental COVID-19 drugs—might lead to far more exposure."