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I think it would be a very straightforward protocol. If someone is seriously ill enough to present at the emergency room and tests positive for Covid-19, enroll them in an early intervention blinded Phase 2 for B. Give 2/3 of the patients an IV of B and give the other 1/3 a placebo. Do follow-up bloodwork at 1 week to compare viral load and track all participants to see how many eventually require hospitalization. As I think about the issue, it becomes clearer to me at least, that Leo had to go the moderate to very sick cohort. After all, B for C will be an IV, not an injection, nor a systemic pill nor even an inhalable. So, we need to be hospital or at least institutionally based, so we end up needing to treat folks in an IV setting. Of course earlier treatment would have been ideal, but I am just not sure how (and where) we would do that, and how would the drug be administered?
My thoughts are that one dose of B will knock the virus down hard enough that none of the patients receiving B require subsequent hospitalization. There are doctors on this board... Thoughts?
Empiricst1 said,
Somebody please sticky FatAlbert’s post.
Well done! LOL!
Direct link to the article...
https://www.pharmaceutical-technology.com/news/innovation-dosing-frequency-trial/
Absolutely NOT!
Hugon said,
Shouldn't Leo try to sell the company for 2-3x current MC? get us up to .40 then go for the sale in the .80-$1 range.
I think a version of Brilacidin delivered through a nebulizer is much more likely.
Spoodio said,
Any word of tthe development of a tablet formulation of Brilacidin specific for antiviral use....? Prophylactic use if exposed to COVID...possiblyl an extended release formulation?
You mean, “That said its clear that the SP volatility is being driven by a few large short holders.”
Botash said,
That said its clear that the SP volatility is being driven by a few large shareholders.
Agreed. Even $5M per year of revenue would radically change things for this company. Our current status as a non-revenue producing biotech has made us an easy target for nefarious manipulators.
Lemoncat said,
IPIX with even $50M revenue per year is a hugely different company than what we are dealing with right now.
From that link - Interesting...
2021-02-11 13G -Kips Bay Select LP...................20,978,229 - 5.37%
2020-07-15 13G/A -Leviston Resources Llc.........15,960,000 - 4.90%
2019-01-22 13G/A -Aruda Wayne O.......................6,266,824 - 3.66%
2014-09-04 13G -ARUDA, INC................................8,000,000 - 7.40%
Please let us know your experience with the Pick Vitamin “Anatabloc”. Also I’m trying to compile a list of those of us still using Anatabine so perhaps we can communicate if something is found that would be of interest. The email address is Anatabloc at mail.com . If you would like to be on that list, please send me an email.
Good question. Do we have CPA on the board that can answer this question?
Lemoncat said, [
i]How do we have an Accumulated Shareholder's deficit of $101M but only $23M in NOL carry forward.
I think that it’s absurd that you find the premise absurd. I myself think the premise is unlikely. However, given the nefarious reputation of the CCP, I don’t think it’s impossible and therefore certainly not “absurd”. But then absurdity is just another opinion...
Minnesinger said,
I found the suggestion to which I responded absurd and presented two equally absurd consequences to underscore the absurdity of the premise.
“B” obviously.... The Chinese Communist Party (CCP) is known for stealing IP across a wide variety of industries. Even the big companies have trouble doing anything about it.
Minnesinger said,
B) China has stolen the formula and is manufacturing our IP without compensation, knowing our penny-ante pharma lacks the resources for recourse.
China is heavily represented on that list. Wouldn’t it be something if it turns out that China’s success in dealing with Covid has been because they have been using Brilacidin to treat Covid for almost a year now? Huummmm.....
Truth...that’s both scary and infuriating.
MinnieM said,
Birth defects a concern? Not to worry. A law has been passed that lets drugmakers off the hook. But, what about the families experiencing birth defects and cancer by playing this game of Russian Roulette? Who cares about them? defects a concern? Not to worry. A law has been passed that lets drugmakers off the hook. But, what about the families experiencing birth defects and cancer by playing this game of Russian Roulette? Who cares about them?
So to clarify the impact your numbers have on the premise posed by Lemoncat; when using the same cell lines, while Brilacidin had only ~half the toxicity, it also had almost five times the anti-viral capability. So comparatively speaking, and contrary to Lemoncat’s supposition, Brilacidin’s high SI in relation to Remdesivir is due primarily to it’s much higher anti-viral capacity.
RuleRationale said,
Brilacidin:
426 (CC50 = 241 µM/IC50 = 0.565 µM), Calu-3 Cells [1]
Rem:
38 (CC50 = 50 µM/IC50 = 1.3 µM), Calu-3 Cells [2]
Thank you sir!
Almost makes me wish I had not changed my mind about becoming a lawyer...
Barron4664 said,
A class action lawsuit alleging violation of the fifth amendment right to due process might be an avenue for traders of GME and other stocks that these so called SROs allegedly required robinhood and others to ban the buying of might work. At the same time FINRA and DTCC might be sued in the court of federal claims for a takings.
I had to try three times. I think the key to my success was I finally refreshed the CAPTCHA. I have learned to copy my posts for such venues before trying to submit it because this is not the first time I have had to make multiple attempts to post a comment to an article. Good luck and thanks for the effort. BTW - I enjoy your posts here as well.
@ “James” and “An Old Chemist” - Thank you both for chiming in with me in the comment section of the article linked below.
https://blogs.sciencemag.org/pipeline/archives/2021/03/04/molnupiravir-last-of-the-small-molecule-coronavirus-hopes#comment-339969
Why? There was a 24% reduction in all-cause mortality and those results are quite a bit better than the current SOC.
HereToday said,
...the share price will definitely take a beat down Monday...
I think your observations are spot on!
About the EUA... The USA is not the only game in town. There are 195 countries in the world. If our Covid Phase 2 indicates that Brilacidin is significantly more effective than the current SOC, I would be very surprised if at least one of those 195 countries did not go ahead and approve their version of an Emergency Use Authorization (EAU) for Brilacidin. In that case, if I were Leo, I would give that country a heavily discounted first mover price on the purchase of Brilacidin. Then the FDA could try to explain to the American public why our loved ones have to die rather receive the best life saving medication available. At that point, somebody at the FDA would have to explain it to President Biden and then a couple of televised congressional sub-committees meetings. Anyway... I’m willing to wait for the results of the trial. No need to panic and give away the store.
Lemoncat said,
The risk here is extreme without partnership. Even if we don't outright fail, not receiving EUA would be a devastating blow. We would then have to fund phase 3 and lose at least another nine months. If we do fail...well you can look back at where we were in Jan 2020.
$5? No. Absolutely not. I believe that Brilacidin could be almost the Holy Grail of drugs. I believe that it could well prove to be efficacious against many if not most viruses and bacteria; as well as many other diseases and conditions such as Ulcerative Colitus and Proctitis. And then there are still the options for an inhaler, topical applications, coatings for surgical implants, and possibly other coatings for sterile environments.
I intend to ride this train and see just how far it can take me. All aboard!
Lemoncat said,
I would gladly take a $5 buyout prior to results and would probably take it after the results if we don't get EUA.
Actually, the motivation could be “the almighty dollar”. If the naked short position is as big as some have speculated, then these criminals could be trying to keep from losing billions of dollars when the price of IPIX shares finally explode. But if that Phase 2 proves that Brilacidin works against Covid, they will no longer be able to control it.
DrPaddleboarder said,
This is being done for criminal intent not the almighty dollar.
They could make ten times the money by letting it run but are deliberately holding the price down for chump change.
Their actions are being done to hurt the company, nothing more.
Strangleholding a potential exciting CV therapeutic is something to be proud of...Amazing
Well said LK! As to the Dud’s reference to the New England Jounal of Medicine (NEJM) as compared to the journal Viruses, I checked up on the most current year available (2019) SJR for both. When you limit your search criteria to journals with citable docs on virology, the journal Viruses is ranked 15 out of 71. The NEJM is not even listed. Anybody interested can click on the link below.
https://www.scimagojr.com/journalrank.php?category=2406&type=j&min=0&min_type=cd
LilKahuna said,
Yeah! Who are these chumps?
At the top of the paper:
National Center for Biodefense and Infectious Diseases, George Mason University, Manassas, VA 20110, USA
Public Health Research Institute, Rutgers, New Jersey Medical School, The State University of New Jersey, Newark, NJ 07103, USA
Um, who is the “New England School of Medicine”?
Thanks and well done. You brought a smile to my face.
My wife and several other educators in her school got the 2nd Moderna vaccine on the same day last week. All had to leave work early the next day. The symptoms were varied: Some had fevers up to 102 but my wife did not have a fever; other side effects experienced by some or all, included headaches, nausea, chills, fatigue, and sore arms. After taking off early the day after, my wife went back to work the next day but had a very sore arm for 5 or 6 days.
Gohel said,
...please be aware that the second Moderna shot is associated with an arm reaction. Your arm may swell and hurt after second Moderna shot.
That’s good DD. Thanks for posting it.
20% is ridiculously low unless that percentage increases substantially as total sales increase. If Brilacidin works against Covid, the governments of the world are going to write very large checks THIS YEAR. A big upfront payment is not worth much when the gross is going to dwarf the upfront payment in the short term. And giving 80% of the revenue to a “partner” who did NOTHING to get us to this point is an insult. Again, if Brilacidin works, we do NOT need a BP “partner”. We already contract the production and the finished product can be direct shipped to the appropriate address. All that remains is to deposit the checks (or just confirm that the proper funding was wired into our account).
After the Covid crisis has passed, I could see Leo signing with a BP to develop Brilacidin for innumerable uses (bacterial, virus, parasitic, IBD, biofilm, and perhaps even medical device coatings or other surface coatings that incorporate Brilacidin). But hopefully Leo is smart enough to negotiate a sliding scale of royalties that gets us to 50% after gross sales reach a billion or so.
Falcon said,
The royalty would probably be at least 20% of revenues but hopefully more like 30 to 40%.
This really puts the spotlight on the never-ending purveyors of FUD here on iHub.
Steelyeye said,
Wow, not only has Mr. Ehrlich been keeping his word about Trial timelines give this evening's Russia info, but with the recent NT filing, I feel we're going to see some fireworks the next two trading days.
Thank you sir!
And once more you come through with the truth, the whole truth, the FUD busting truth! One question, who is the “OG” that is repeatedly referenced in that thread?
Farrell90 said,
"Assuming similar distribution and accumulation ratios of remdesivir and Nuc-TP in the lung between humans and monkeys, an optimistic estimation of Nuc-TP in the human lung tissues is 2 to 3-fold higher at a steady state than that observed in the monkey lung tissues [1]. This suggests that an IV dose of 200 mg remdesivir in a human may only achieve a suboptimal concentration of active form of Nuc-TP of <?2–5 µM in the human lung tissues (TableIII). Given that the intracellular volume (0.54 l) is 46% of the total volume of the lung (1.17 l) [17], the intracellular concentration of Nuc-TP in the human lung may be only at 4–10 µM (TableIII), which may be below the estimated intracellular IC50 and IC90 of Nuc-TP. Unfortunately, systemic adverse effects such as hepatotoxicity preclude escalation of the remdesivir dose to more than 200 mg/day."
The following article demonstrates these findings in great detail.
https://link.springer.com/article/10.1208/s12248-020-00459-8
GLTA Farrell
So you’re worried about “the timeliness factor”? Well if you're adamant that IPIX can NOT contract production as fast as Gilead or Merck...fine...you believe what you want.
Lemoncat said,
It's the timeliness factor not whether it can be done eventually or not. If you're adamant that IPIX can do it as fast as Gilead or Merck...fine...you believe what you want.
So no government in this world will want a CURE if it’s not marketed by BP? That would be sad indeed if the CURE could not be had because all governments refused to buy it from a company that was too small to “pay to play”. And if even one government did write a check to that little company, what are the chances that the rest of those governments would be able to satisfactorily explain to their citizens why they also didn’t buy that CURE?
Also, for the record, it is ludicrous to say that it would not be possible for little IPIX to contract enough production to meet the worldwide demand. That assertion is literally ridiculous.
Lemoncat said,
I'm still waiting for an example of the government writing a billion dollar check to a company other than those four big pharma entities. Forget about number of employees.
And how many employees a company has, has nothing to do with it. It’s the product and the ability to get it produced. We have those covered already.
Lemoncat said,
All (of those billions) to big pharma companies or small companies who have partnered with a larger company. Astra-Zeneca, Pfiezer, Moderna, Gilead. Who am I missing? Give me an example of a company with <5 employees.
Excuse me... 10Q
Really? I don’t think so. I will break up my response so that there will be no doubt as to the veracity of my remarks.
Lemoncat said,
This is willful ignorance of how this process works. I can all but guarantee you that Brilacidin for COVID will not reach the market without a big pharma partner.
The government could hand us $100M dollars tomorrow to scale up and it would likely take us years to produce the volumes needed by the world in 2021.