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I know. I was just pointing out the flaw in his basic argument that Brilacidin had more AEs than Daptomycin. I figured that would be easier to understand for any investors who may be new to this board and IPIX.
Lemoncat said,
In the ABSSSI trial, Brilacidin may have had twice the number of AEs but Brilacidin also had three times the number of patients. There were 4 equally powered arms in that trial; 3 for varying doses of Brilacidin and 1 for the standard Daptomycin dosing protocol. So given these facts, Brilacidin actually had a better AE profile than Daptomycin.
Sunspotter said,
Interesting…
Thank you. Actually when I read the first article, I wondered why that combination would not be found in nature, and the article did not answer that question to my satisfaction. Though I am admittedly not qualified to be the “arbiter” of the content of either article, the rebuttal certainly sounds logical.
Thank you.
My brother and his wife each took the Covid Test at home and the test results were positive. They had nausea, vomiting, diarrhea, fatigue, and fever. When his O2 stats dropped below 90%, (August 20) he and she went to the hospital and both were given IV fluids in the ER but his O2 stats were back in the mid-90s and they were sent home. August 22nd he was back in the ER (different hospital) where they did a Covid test and it was negative. He stayed in the ER until he got a room on the 23rd and was sent home on the 25th. He passed out in his bathroom the morning of the 26th and they called for an ambulance. This time he was taken to a third different hospital because all the others were full and not accepting new patients. This time he tested positive for Covid again. After 40 hours in the ER on oxygen and IV fluids, he was admitted to a room. He is still there on oxygen but doing pretty well. He can talk on the phone and thinks he would be fine to go home if he could still be on oxygen.
So he tested positive at home, negative at one hospital, and then positive at another hospital. I also question the accuracy of the testing.
MinnieM said,
So you don’t think that some desperate foreign government will take some shortcuts, expedite an EUA, and make a quick purchase; thus beating the US to the punch?
CallMeCrazy said,
Exactly! The mild Covid cases, and possibly even the everyday flu or cold, might be best treated by a Brilacidin inhaler. I am looking forward to those Phase 2 results!
Redwing said,
I think that to accuse IPIX employees of scientific fraud (and other unethical conduct) without any evidence is an offensive thing to do.
Sunspotter said,
Upon further review, I agree. The “deliberate misrepresentation”, must be coming from the Gilead employees who conducted that SI lab work. I’m glad that the SI lab work for Brilacidin was done by one of the independent Regional Biocontainment Labs.
Sunspotter said,
We know that Brilacidin’s SI was determined by an independent Regional Biocontainment Lab (RBL). Was that SI for Remdesivir arrived at by research professionals independent of Gilead? It appears to me that many of the authors of that study were employees of Gilead.
Minnesinger said,
I very much hope that you are right. I think my first stock purchase of IPIX was in 2012. I have been posting on this board since 2013. I am still here because I believe in the company and our drugs. But I have seen too many things with the FDA that did not make sense, so I am concerned. Will the FDA (this time) make the correct, science-based decisions, in a timely manner, that are in the best interest of American citizens? Or will they make decisions that are in the best interests of their primary funding partners in Big Pharma? Or will they just allow the process to bog down in bureaucracy while our fellow citizens continue to die?
If our Phase 2 is successful, I think IPIX will be fine regardless. There are too many countries out there whose citizens are suffering and desperately need a way to respond to this pandemic. Good luck to all longs!
CallMeCrazy said,
That sounds reasonable. Unfortunately, I have no confidence that the FDA process for EUA will be reasonable. If they use an advisory committee to evaluate the EUA application, then there will probably well credentialed individuals on there who get major grants from competing Big Pharma (BP) companies. Amazingly, in the past, the FDA has not considered that a conflict of interest. But with all the current and future BP revenue at risk for other treatments and vaccines, they certainly have a reason to try to slow the approval of the EUA.
I would not be surprised if one or more foreign countries were the first to approve an EUA for Brilacidin. This might result in the US being at the back of the line for Brilacidin.
And there is no reason for how slow this process has been. Two independent Machine Learning studies had identified Brilacidin as one of the most promising inhibitors of SARS-CoV-2, the virus responsible for COVID-19, based on Brilacidin’s molecular properties. Besides that, the April 1, 2020 PR revealed that “ Brilacidin testing at a US Regional Biocontainment Laboratory resulted in a dose dependent reduction of Covid in viral teeters.” The “powers that be” certainly had multiple heads-up moments in that April - June timeframe in 2020.
Any legitimate evaluation of Brilacidin by people in authority following the release of those lab results back in June of 2020 should have resulted in an all hands on deck type response. Instead here we are 14 months later just wrapping up a Phase 2 human trial. Nearly 4,000,000 people have died since last June while people in authority twiddled their thumbs.
May 19, 2020 PR - …Brilacidin, in an in vitro experiment using VERO cells, reduced the viral titer (load) of SARS-CoV-2 by 75 percent after only 1 hour…
May 26, 2020 PR - In a human cell line, Brilacidin, in comparison to vehicle control, exhibited an inhibitory effect on SARS-CoV-2 in a dose-dependent manner—an average 29 percent inhibition at 0.1ug/ml (the lowest concentration) to an 85 percent inhibition at 100ug/ml (the highest concentration).
June 17, 2020 PR - Brilacidin exhibited a statistically significant (p<0.0001) and potent inhibitory effect on SARS-CoV-2, the novel coronavirus responsible for COVID-19, in a human lung epithelial cell line—reducing viral load by 95 percent and by 97 percent, compared to control, at two therapeutic concentrations tested. Based on a CC50 value—the concentration of drug at which 50 percent of cells maintain viability—Brilacidin was also shown to be non-cytotoxic in the lung cell line.
CallMeCrazy said,
LOL! Finally got my first shot (Moderna) Thursday. This Delta variant is making it pretty obvious that it’s just a matter of time before I catch it.
I’ve been seeing too much suffering going on around me. And the suffering seems to be worse for family, friends, and acquaintances that are not vaccinated.
Loanranger said,
Good point!
Williams’s said,
But he also said…
DonnieBaseball also said,
You said yourself that there are 2 “other useful standard(s)for success”; “a sale or licensing agreement.” So you agree that the poster was wrong in saying that there is only one measure of success for a Phase 2. That makes his assertion that all Phase 2’s failed also WRONG even by your standards. Because one of those Phase 2’s (B for UP) resulted in a “licensing agreement.”
I do disagree with both of you as to your very limited definition of what constitutes a successful trial. Every human trial, whether Phase1, 2, or 3, must first be judged based on the results. For Brilacidin, they have all been successes. The indications have not been monetized YET, but that does not mean the trials were a failure.
Loanranger said,
It also wouldn’t be very hard with EUA’s from multiple countries that resulted in a few million doses sold for even as low as $500 per dose.
Hugon said,
I very seriously thank you for that post. My background is in business not biology. But how can the patient have Covid but it not be present in the “olfactory bulb”? I would have thought that it would be hard to breath in the virus and then have it bypass that organ. How can that be?
From Pipi’s post,
I did read your post in its entirety and what I know about exosomes came from your very interesting post. I can see from that post where exosomes could relate to Covid19, but my question was how exosomes relate to Brilacidin? What was your point? You made a seemingly excellent post that was apparently for two separate subjects; 1) Brilacidin, and 2) exosomes. I don’t think it’s too much to ask that you also explain the relevance of one to the other. But whatever…
PreciousLife said,
And how do exosomes relate to Brilacidin? I’m missing something…
But if (or should I say when) the share price reaches $2 per share within the next 12 months, it looks like the Company would at that time most likely be able to meet the listing requirements based on the Market Value of Listed Securities Standard under Rule 5505(b)(2).
Loanranger said,
Who’s “P”?
Pipi said,
That’s what I thought when I first saw the trial description. It’s like they really don’t care how many people die waiting for the bureaucracy. Your comments about proceeding at the 30 day mark makes sense. I think the 60 day requirement is ridiculous and unnecessary. People are dying every day while the bureaucracy twiddles its thumbs.
Attilathehunt said,
Could you post or PM a link to the obituary?
Do you know the cause of death?
Rest In Peace Annette. You will be missed.
Thanks for letting us know Cassius.
I was joking of course about us rigging up a nebulizer with OM sachets. But I do think a Brilacidin Phase 1/2 for a nebulizer could be quick and cheap. Combine safety testing with a viral teeter comparison before and after. They did a quick and cheap Phase 1/2 for Ulcerative Proctitis and that worked out well for us.
Justfactsman said,
Perhaps we could use the sachets that went to make the oral rinse to make our own nebulizers. Add the sachet of Brilacidin to some distilled water in a mister and squirt the mist in your nostril as you breath in. Why not? Now where can I get some Brilacidin sachets?
Petemantx said,
No.
1. I think there is good chance that Brilacidin will generate significantly more than $4B.
2. Even at sales of only $4B, a fairly conservative price/sales ratio of 12 would deliver a share price of over $100 per share.
So no, if this Phase 2 Covid trial is successful, I do not think that $10 per share is even close to a fair valuation.
Lemoncat said,
sunspotter said,
The ScienceNews.org article you cite said,
It sounds like Anatabine could do the job.
Knuts said, “ ‘Furthermore, they found that infected gut cells mounted a pro-inflammatory response to the virus by pumping up levels of the transcription factor NFkB and the cytokine TNF.’ Does the last sentence sound like MYMD-1 could do the job!”
Something doesn’t sound right. It was reported that Brilacidin combined with Remdesivir was better than either one by itself. Could someone have made a mistake when putting together the publication?
OldenGrumpini said,
Assuming that Brilacidin performs well in the current trial, IMO millions of people worldwide “will have died needlessly.”
Petemantx said,
I agree and I think it would be a Phase 2 with a very straightforward protocol. If someone is seriously ill enough to present at a doctor’s office or the emergency room and tests positive for Covid-19; that person would be enrolled 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.
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?
If the CTA requires a company to “donate” an equity (or ownership) position to participate, I’d have to know the details before I'd support that.
CallMeCrazy said,
Something doesn’t smell right...
Barron asked,
This is good information. Thank you for this and your other efforts to add real value to these message boards!