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LR I much appreciate the dd that went into this post.
Glad you sent a note. I was us going to ask you for your take. Unfortunately, I agree with you lots. I think I need to go on the Alfasigma link on LinkedIn, a few guys I used to work with are on there as IPIX boosters. Leastways they were as of a few weeks ago. I'll get on for the hell of it and see if I can see what they think. I need some cheery news. I do wish Alfasigma gave reports on its ongoing studies but I have been unable to find much (any?) recent material from them re Brilacidin and IBD.
PJ, if I sold out now I'd get 10 thousand or more (these are not exact numbers as it is too depressing to actually work the exact numbers), lots of us would. I felt the same way if I would have cashed out at about $100,000 or so at the covid top. I didn't. In a month or two I will probably consider myself an even bigger idiot. I have no idea why I am staying. Ok, maybe the faint hope of an IBD chain of good things that could happen.
Smiley67, I do not even begin to attempt to question or challenge your decision process. Good luck. Uh, large pieces of my soft parts too, lie shredded on the floor.
"So I'm sorry for disputing what you said. I was wrong"
How nice of you. I just wish we had more substantial things to joust about, like ongoing tests, costs, results.
But I do appreciate your laying out the process and its rules in detail.
I meant the submission of the results of a competed PH3.
"And what happened next?"
Nothing happened next, we all know there was never a submission. Are you making some sort of point here, if so please let me in on it. This does not change my contention that FDA worked with the company to develop a protocol for the FDA PH3. As I said.
The materials are from the Library of Congress site. The materials appearing on the site could have been used by IPIX any way they wanted to. The materials I showed were from the cites I mentioned.
This from BioSpace See the second paragraph.
Cellceutix To Submit Special Protocol Assessment Request To FDA For Phase 3 Clinical Study Of Antibiotic Brilacidin For ABSSSI
Published: Feb 09, 2016
BEVERLY, MA--(Marketwired - February 09, 2016) - Cellceutix Corporation (CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that it will be submitting a Special Protocol Assessment (SPA) request for phase 3 clinical research of its novel single-dose antibiotic, Brilacidin, for the treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI) caused by Gram-positive bacteria. The Company anticipates submission of the SPA request to the U.S. Food and Drug Administration (FDA) within two weeks.
In July 2015, Cellceutix reported the outcome of a successful End-of-Phase 2 Meeting with the FDA, during which the agency provided input on the Company's proposed phase 3 program. This meeting was a significant milestone for Cellceutix and it triggered the start of phase 3 activities. An agreement was reached in conducting two randomized, well-controlled phase 3 non-inferiority studies, comparing Brilacidin to an approved ABSSSI regimen, with an interim analysis as part of the first study. In addition, and in part related to the novelty of Brilacidin as a completely new class of antibiotic, the FDA requested additional information before the start of the first phase 3 study. Cellceutix is pleased to announce that it has completed this research, compiled the requested information and is submitting it, along with the final protocol for the clinical studies, in the request for a SPA.
A Special Protocol Assessment is a written agreement between the FDA and a drug sponsor detailing the clinical trial design, endpoints and other clinical trial facets that can be used to support regulatory approval, thereby potentially reducing the risk of bringing a drug to market. In the SPA request, Cellceutix is including its choice of comparator for the phase 3 program, consisting of intravenous vancomycin with an option to switch to oral linezolid after three days of therapy. This is considered conventional therapy for ABSSSI and is the same comparator used in the phase 3 program for a recently approved ABSSSI drug.
"Submission of the SPA request is an important milestone in initiating the phase 3 studies of Brilacidin. Using this process helps to ensure harmony with the FDA on trial design and endpoints for this first-in-class antibiotic that we believe has the opportunity to deliver a meaningful impact to ABSSSI patients with a reduced likelihood of resistance developing compared to competitors," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "We want to enter this market as we believe with the right partner or distributor, a successful trial resulting in an FDA approved Brilacidin for ABSSSI, it could be a market leader and potentially generate hundreds of millions of dollars annually."
Alerts:
Sign-up for Cellceutix email alerts is available at http://cellceutix.com/email-alerts/#sthash.CRfqSmmY.dpbs
Cellceutix clinical trials on Clinicaltrials.gov:
https://clinicaltrials.gov/ct2/results?term=cellceutix&Search=Search
About Cellceutix:
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in multiple diseases. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the "Guardian Angel Gene" due to its crucial role in controlling cell mutations. Cellceutix is in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol is in a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com.
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The materials are from FDA sources, provided by the companies who have conducted the tests in accord with FDA procedures. You seem to categorize the data/info as somehow negative because it was originally produced by the companies. Who else would produce it?
Brilacidin had an IV treatment effect in one day, equivalent to 7 days on a Daptomycin IV. I'm neither shilling nor bashing Brilacidin for ABSSSI. There is some obvious treatment efficacy potential and more side effect occurrences than Daptomycin. An FDA PH3 could set the record straight. If FDA felt the Brilacidin side effects were too severe when balanced against its anti-biotic potentials, it would not have worked with IPIX regarding protocols for a PH3. IPIX stated it did not have the estimated 34 million to conduct the PH3.
NIH/National Library of Medicine
8600 Rockville Pike
Bethesda, MD 20894
NLM NIH HHS USA.gov
Take it for what it's worth. Unbiased federal source.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3854692/
Above footnote 13, I copied the last of the paragraph
Gotta run, will dig it out later.
Additionally, BP/hypertension using Brilacidin was much higher in the 3-day and singe dose regimen.
And you no doubt saw the NIH cite from Dec. 3, 2013. Nothing is clearly settled and would benefit by an FDA PH3
"The trial achieved its objectives of meeting efficacy in all evaluated doses of brilacidin (see Table 1). The safety profile of brilacidin was notable in that there was reporting of numbness and tingling in 65-87% of patients, but the event was insufficient to cause discontinuation. Excluding this numbness, the treatment-related events were 9.5%, 5.6%, and 7.4% for the low, medium and high-dose groups respectively, compared with 10.9% using daptomycin. Eight patients discontinued therapy due to treatment-related events, two due to hypertension [13]."
Table 1.
Clinical response of brilacidin (PMX-30063) and daptomycin in acute bacterial skin and skin structure infections: a Phase II study
Clinical response Low dose Medium dose High dose Daptomycin
N = 52 N = 54 N = 54 N = 55
Day 3 94.4% 90.7% 81.5% 90.6%
Day 7 87.0% 92.6% 83.3% 96.2%
Sustained response
Day 10 90.2% 91.8% 95.5% 97.9%
Day 28 95.7% 89.6% 95.6% 98.0%
And from your citation, the incidence of BP/Hypertension was more than double in the Daptomycin group (10%) than the Brilacidin group (3.8%).
Dr. Farrell, do you have a perspective on Sunspott's comments regarding SE issues with Brilacidin? If you do I (and no doubt lots of others too) would love to read them.
"One of the main takeaways for me was that a lot can happen in small drug development companies over a decade."
Point well taken.
Because of management decisions made in this period we may never know if Brilacidin or even Kevetrin can help some serious medical conditions and also produce shareholder profits.
The point was that Mako was short and their Rosen lawyers defended a short that played loosely with the facts. If you are a lawyer that makes income from defending shorts, are you a short? Why would I ever imply I thought Rosen lawyers or the corporate group itself shorted stock? But yet, in shorthand I have referred to them as shorts.
This from BioSpace. Please scroll down to the start of the fourth paragraph.:
Anonymous Short Trader Attacks Cellceutix Again
Published: Jan 19, 2017
Anonymous Short Trader Attacks Cellceutix Again January 19, 2017
By Mark Terry, BioSpace.com Breaking News Staff
On January 17, a short seller writing under the pseudonym Mako Research on Seeking Alpha, took a shot at Cellceutix under the title, “Cellceutix: Financing Partners Arrested For Alleged Ponzi Scheme, Company Faces Risk Of Death Spiral Liquidity Crunch.” Cellceutix strongly denied the claim and released a statement calling Mako a “non-credible criminal author.”
Cellceutix, based in Beverly, Mass., was founded in 2007. It focuses on developing therapies in dermatology, oncology, anti-inflammation and antibiotics.
This is not the first time Mako has gone after Cellceutix. On August 6, 2015, Mako wrote a piece on Seeking Alpha, a whopping 12,000 words long, attacking the worth of the drugs the company was developing, but also accusing it of being “nothing more than a shell corporation.” At that time, Cellceutix denied the charges and invited members of the media to visit the company and see for themselves. Don Seiffert, writing for the Boston Business Journal, took them up on the offer. And in his account, it seems that the company is legitimate, does do research, and has had drugs in clinical trials.
Mako clearly states that it shorts Cellceutix stock. Seeking Alpha, an investor website, has a policy on its website that it allows some of its contributing authors to use pseudonyms, but the publisher itself requires the authors’ full names. They must also reveal any stock positions they write about.
The Mako Research bio, such as it is, on the Seeking Alpha website, describes itself as “Professional investor and overall good guy,” followed by a lengthy disclaimer. The most recent post blasts Cellceutix, citing that “Key CTIX financing partners from Platinum Partners arrested for participation in alleged $1B+ ‘Ponzi scheme’” and concluding, “We revise our fair value estimate for CTIX to $0.00 and downgrade the stock to Strong Sell from Sell based on near-term bankruptcy and the ‘death spiral’ liquidity crunch underway.”
Cellceutix responded with a strongly worded statement, saying, “As with Mako’s prior article on Cellceutix, the non-credible criminal author makes countless unfounded, wild allegations about the Company. The purpose of the iniquitous writings of Mako is to scare shareholders and drive CTIX stock lower for the profit of the author and all organizations collaborating in the illegal and manipulative market activity often called, ‘short and distort.’”
It also cites a court case between Cellceutix and Mako. It’s apparently not the only lawsuit. A shareholder of Cellceutix sued the company in New York federal court after the 2015 article, as well a case filed by Mark Nordlicht, the founder of Platinum Partners, who sued Seeking Alpha for defamation. Both of those cases were dismissed in 2016.
At this time, the U.S. Securities and Exchange Commission (SEC) declined a request for a statement about the company by the Boston Business Journal.
Otherwise, on January 17, 2017, Cellceutix announced it had completed the second cohort of a Phase II open label Proof-of-Concept clinical trial to evaluate Brilacidin for mild-to-moderate ulcerative proctitis/ulcerative proctosigmoiditis, two types of inflammatory bowel disease.
“To date, the trial has exceeded our expectations on all fronts” said Arthur Bertolino, Cellceutix’ president and chief medical officer, in a statement. “The study needs to be successfully completed with the final data fully analyzed, but at this point we attribute the early favorable results to Brilacidin’s robust anti-inflammatory therapeutic profile. Given Brilacidin’s unique mechanism of action, the body is able to get back to doing what it’s usually already good at—fighting illness and infection.”
Cellceutix is currently trading for $1.13.
Insider Financial also took a crack at the story today, noting that after the 2015 story and resulting court cases, “Both cases were dismissed extremely quickly, and a raft of post-release due diligence proved that most of the claims outlined in the article were spurious at best, or outright false at worst.”
And this time, Mako is essentially regurgitating the same “facts,” only throwing in new allegations regarding Platinum Partners. Insider Financial notes that the company is developing three primary assets, has moved into several Phase II trials and a Phase III trial is pending. “Mako’s article claims that each of these assets has been proven ineffective and worthless by a third-party independent medical professional. In allowing them to move through the development process, however, the FDA is directly refuting the claims of said (anonymous) medical professional.”
This is from a Seeking Alpha post at the time. Additional substantial materials could take lots of dd. I'm not sure it's worth the effort. Whether they were actually short, or just acting to damage a little company and get bought off by a settlement does not really matter much from the perspective of the defendant. They are damaged and can choose to fight or pay up. CTIX fought and did not pay up, though it did not countersue.
Cellceutix Thwarts Frivolous Class Action Attempt; Has The Rosen Law Firm Been Exposed?
Jun. 10, 2016 10:13 AM ETInnovation Pharmaceuticals Inc. (IPIX)83 Comments
Summary
Cellceutix successfully defends a poorly conceived and potentially frivolous lawsuit.
The Judge, in a 39-page decision, refutes every legal argument presented by The Rosen Law Firm.
Decision made with prejudice; this matter is closed.
Has the decision exposed The Rosen Law Firm's modus operandi?
Cellceutix (CTIX) announced on June 8, 2016, that the U.S. District Court for the Southern District of New York has granted the motion to dismiss, with prejudice, the class action suit brought against them by plaintiff Greg Zagami and represented by The Rosen Law Firm. The 39-page written opinion by the court dismantles each and every argument presented by Rosen, citing supportive case precedent and further ordered that the claims presented have no merit, and as such, the case shall not be re-filed.
For Cellceutix, shareholders have hope that management will not allow this perceived attempt of lawsuit-based extortion to end peacefully. Rather, many feel that Cellceutix should aggressively pursue sanctions against Rosen, seek the return of all legal costs associated with the case and pressure the SEC, FBI and U.S. Postal Service to continue a vigorous investigation to determine if any communication between The Rosen Law firm, Mako Research and the lead plaintiff, Gary Zagami had occurred prior to the publishing of an article by Mako Research on August 6, 2015.
If leveraged properly, the decision by the court has the potential to limit the way the legal system can be used to exploit small companies who fall victim to providing an unnecessary defense against frivolous lawsuits. Many acquiesce to the path of least resistance and settle a case instead of undertaking a litany of costly and time-consuming legal filings, which incentivize a settlement rather than a defense. In its decision, though, the court cited extensive case precedent that admonished the "weak" claims that were made by The Rosen Law Firm. Because the court was meticulous in lining out its written decision, these well-versed precedents can be argued by the next victims faced with apparent frivolous accusations and far reaching claims of intentional deception.
In reviewing the past cases that The Rosen Law Firm has settled, it is apparent that they invoke the same method of attack on others as they used on Cellceutix. The firm relies heavily on sections 10b and 20(a) of the Securities Exchange Act alleging that a company has provided materially false and misleading financial information to shareholders.
Of the 60 cases presented on The Rosen Law Firm website under the "Recent Successes" tab, Rosen utilized Sections 10b and 20(a) of the 1934 Securities Exchange Act no less than 40 times and raked in settlements in excess of $179 million for the 60 cases listed on their website. Many of these cases were settled without trial and the preponderance of settlements were within the range of between one and two million dollars. Coincidentally, Greg Zagami, the plaintiff in the Cellceutix case also served as the lead plaintiff in another Rosen case filed against Natural Health Trends Corporation, a case that settled for $2.75 million, payable to class members after legal fees and expenses. Zagami and two other lead plaintiffs were awarded $200,000, plus interest.
Certainly, there can be no argument against some of those cases having factual validity. However, it is also fair to state that many of these companies, who were not guilty, lacked the resources to vigorously defend themselves in a costly legal battle. In the United States, the vast majority of civil actions are settled out of court and prior to trial. Estimates run as high as 90% of all civil lawsuits settled in this manner. Sadly, for small and emerging companies, a settlement of one million dollars to avoid a costly class action battle is a preferred alternative
For class action cases, an interesting study was prepared by Mayer Brown, LLP. In her study, she analyzed 148 class action cases and found some interesting results. Within her data set, she found that in the majority of cases, settlements provided little to no benefit to the plaintiff or the represented class. The predominant financial rewards went to the attorneys who represented the cases, often enriching themselves though legal fees and costs associated to the case.
Interestingly, not one of the 148 cases ended in a decision that favored the plaintiff case on an award of merit. Only 14% of the cases went beyond one year, with approximately 20 cases still pending after a four-year period, without resolution or a determination as to whether those cases had merit to continue as a class action case. Her study demonstrated that the consistent winners of any class action lawsuit are the attorneys, not the certified class. Although, as seen in Zagami vs. Natural Health Trends Corp., lead plaintiffs might have incentive as well.
It is statistics like those that have many people questioning the state of the legal system in the United States. The enormous costs and time necessary to defend against frivolous action is almost cost prohibitive to many small and emerging companies. Public companies, who often tap the capital markets for required operating funds become easy prey to unscrupulous legal firms who expose semantics in language as a legal cause.
They prey upon the inability of a company to make specific proclamations as to how much money they will earn, the exact amount of funds needed for future development and for their inability to factually predict the future of financial or clinical results. Sound absurd? Well, those are some of the precise arguments made by Rosen against Cellceutix. Thankfully, the dismissal order stopped the nonsense.
For Cellceutix, management can finally begin to focus exclusively on its clinical trials and the strategies necessary to perpetuate the studies. With the Rosen case now history, the company should have greater opportunity to engage a partner or to seek mainstream financing instead of relying on the funding agreement with Aspire Capital, which can be significantly dilutive to the outstanding share count.
There is some sentiment that Aspire is a "white knight" and is at the mercy of Cellceutix management due to their requirement to purchase shares of company stock at a time determined by Cellceutix. The reality of these stock purchase agreements is that they have historically caused a depression to the share price. Aspire has incentive to keep share prices low to mitigate potential risks, while conversely, a higher share price is at the benefit of Cellceutix. Ironically, although the two companies are working together, the two strategies do not align.
For those that see Aspire as a fair and balanced agreement, think for a moment as to whether Aspire would expose themselves to a situation whereby they could be required to purchase one million shares for $20.00 each. After all, that is what the agreement states. Cellceutix can sell stock to Aspire on a weighted average price for a stated number of trading days. Does any investor truly believe that Aspire would be so naive as to create such an unbalanced agreement? The exposure is simply too significant for Aspire to be backed against the wall and be susceptible to purchase stock due to market manipulation. They simply would not leave unmitigated exposure.
The Aspire agreement is appropriate to discuss because it was perhaps the only way the company could come to terms in securing future funding draws. Similar to Ocata Therapeutics though, Cellceutix, with this lawsuit behind them, can be in a position to seek traditional methods of financing, as Ocata did when it secured Silicon Valley Bank. The agreement with Silicon Valley replaced a strikingly similar deal that Ocata management had in place with Lincoln Park Capital Fund.
Now, with the case behind them and the exposure mitigated from future class action loss, Cellceutix should seek new financial partners or mainstream outlets that are willing to lend the company money on traditional and equitable terms, relying on the recent clinical trial updates as a foundation to support a traditional funding placement.
The class action case was an obvious overhang, with many shareholders citing it as the cause for the continued pressure on the stock. But, even with the dismissal, the stock failed to gain any substantial traction on the trading day when the news was released. Volume remained at average levels and except for an early morning spike of 9%, the news of the case dismissal failed to ignite the stock to regain its price levels prior to the Mako piece and subsequent lawsuit. As I stated just a few days ago in a prior article, this case was an overhang, but not to the extent that many investors might have thought.
And although many debate my call and need of a partnership for Cellceutix, the language in the dismissal opinion clearly reiterates that management's statements in its SEC filings indicate that the company will need substantial amounts of money to fund future operations. The company itself has provided ample warning to shareholders to expect significant dilution in the near future.
But, this does not have to be the case. They have strategic options.
First, Cellceutix should aggressively request the court to provide relief for any and all damages caused by the frivolous filing. This can be through sanctions against The Rosen Law Firm.
Second, management should aggressively seek partnerships to fend off the need to dilute the outstanding share count and lessen the need to tap the Aspire equity. The Prurisol results are ripe for a partnership and taking advantage of these results are an opportunity that management should seize upon.
Subsequent to the case dismissal, the potential of a partnership becomes more likely to consummate. Now that the door to injustice has been closed, management should confidently approach potential partners and offer them an opportunity to take advantage of a $13 billion psoriasis market, offering an oral compound that has favorable comparisons to the leading drug on the market, Otezla.
This dismissal is far bigger than the share price reaction has indicated. Markets sometimes invest ahead of news, sometimes they sell the news and sometimes they digest it before bidding a stock in either direction. This dismissal, however, cannot and should not be underestimated in its importance going forward. The courts recognized the reported data as accurate and found no evidence of misleading or inaccurate statements made by management. This is extremely important as the company moves forward in its clinical trials. To have each and every claim made by Rosen dismissed by the court is a resounding victory.
Realistically, an expectation could have been plausible that at least one of the plaintiff's claims had merit, but this was not the case. The plaintiff and its representation took what many believe to be an embarrassing hit and if Cellceutix continues the fight, this case is far from over.
Just as authors use method writing in their prose, I recognize a pattern that was exposed in the Rosen filing. The use of sections 10b and 20(a) allow for a wide latitude of speculation and innuendo. Because of this, many courts have allowed even frivolous cases to move beyond an appropriate dismissal action. However, with the judge taking precise aim at Rosen in this case and providing substantial precedent in the granting of a dismissal order, the weaknesses in the Rosen model may have been exposed. (Click the hyper link above referencing the "recent successes" on the Rosen site to view the patterns and similarities.)
Going forward, companies should eagerly exploit the precedent cited by the judge, employing the will to defend themselves rather than settling quickly to avoid litigation. Regardless of whether insurance companies brunt the cost of some of these financial losses, companies should stand up to the bully pulpit that many class action law firms have enjoyed without much sanction. Litigation reform should be at the forefront of future legislative sessions. However, with the strong lobby group presented by the legal profession, significant changes are unlikely.
If at the very least, reform was legislated that required the losing party to pay all legal costs of the prevailing party, many cases, such as the case brought against Cellceutix, would never have been filed. Of the 60 cases presented on the Rosen cite, potentially millions of dollars in settlements might have been avoided. But, until such reform is enacted, small and developmental stage companies like Cellceutix remain in the cross hairs of the law firms more intent on case settlement than they are about maintaining a level of decency and integrity within the field.
Judges must be willing to adjudicate significant sanctions upon those firms that continue to file cases, which are found to have little to no merit, admonishing firms that should have the legal expertise to refrain from such frivolous attempts at settlements. Until these sanctions are handed down by the courts, the fate of unnecessary litigation will tread onward.
I applaud the Cellceutix management team for taking an aggressive stand in this case, never wavering from its commitment to shareholders or from its commitment to the science and results of its trials. It is prime opportunity to regain momentum and drive the share price higher.
It became obvious that this decision alone will not drive the share price higher. The ball is now in management's court to determine what they need to do to provide shareholder value and demonstrate that the science and data they are proving in clinical trials is as strong as the court determined it to be.
Disclaimer: Not all lawyers are bad. Not all lawyers are good. Some are ethical and some are not. This article is my opinion and does not intend to place The Rosen Law Firm in any particular category. The judge in the District Court of New York provided the best opinion about the case brought against Cellceutix. Investors should rely on that opinion.
Editor's Note: This article discusses one or more securities that do not trade on a major U.S. exchange. Please be aware of the risks associated with these stocks.
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Disclosure: I am/we are long CTIX. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
"the person whose name you forgot and Rosen were never shown to be short:
Are you assuming this was all done as a public service, or to help CTIX shareholders?
"but I damn sure wouldn't bet another $3000 on it."
Uhh, sad but true. Me neither, and I was always up to double down a bit, but now it just seems kind of nuts. All is not lost, but having much confidence just seems nuts.
Are you saying that the military have done invitro research on Brilacidin? If so, where does info appear? I'm drawing a blank.
"I'm happy Leo at least tried and put 10 million in the bank. B for OM and irritable bowel disease is still intact"
I would have been happier if Leo had invested a few bucks more up front, to have injections as an treatment option allowing more people than those already sick to very sick to be treated. When I see the few millions ahead, I think mainly that Leo was puting some away for he and his colleague's own million plus annual take. But I agree that having some money ahead is much better than no money ahead.
"Mako tried to stop the madness years ago "
Mako, Rosen (their lawyers) and another whose name I forget were shorts with little regard for CTIX or its shareholders. Mako and company did not try to stop the madness, they were just out to rip off CTIX shareholders. Nothing more and nothing less, imo. They lied at the time, though Leo has turned most of their contentions to reality as time as passed. Yes, we now hold shares in a staffless shell that seems to exist (with some minor exceptions) as a pay/dilution vehicle for the CEO owner and a co owner. Decent courts could have helped CTIX, but little bios legally just don't count for much. Spending money to "get" justice would have been futile. But we've been over this ground often in the ensuing years. Please don't attach any ethical values to the past short attackers.
"https://www.amractionfund.com/our-investments
This group has been around a while. I wonder if they have contacted Leo, or vise versa?"
Logical question. With Leo, we'll never know the answer. In the past I might have asked him by email. But he stopped answering me, as he has for most others, though I am not even sure if he communicates with any bagholders.
Well Lemon, interesting responses. I appreciate your having spent the time and the thought on them. Problem is I can accept either my negative speculations, or your sometimes more positive ones. But we just can't be sure, as Leo always leaves us short of the types of info investors would like to have. He knows more than he shares with us for sure.
As I take two steps back, I wonder why Leo did not sell tens of millions or more shares at the .25 to .40 level, to raise some money to finish the tests we have both speculated about. On the other hand, if Leo did sell (actually was able to sell big numbers of shares without tanking the pps before it fell from the failed covid test), Leo may not have had enough shares remaining to completely disregard shareholders, as he appears to have always done. And, since he has his and his friend's gross paydays in tact, he has not acted, or at least imo that could be why he did not sell lots of shares (again, to the extent that he could have) to accrue some money to finish testing. Hard to take our little shell company seriously, but for the fact that lots of us have poured some serious money into it, or rather right into Leo's pockets.
Mack, I'd expect no less from you. And that is not a shot.
And going further, there is no practical way for the board participants to exert any control by voting our shares. As a group (even including those who no longer post here) we don't have enough shares. Last time I ran the numbers was a year or more ago. I guess I should spend the dd time if I am going to mention the issue of powerless shareholders, except for Leo and company that is.......
"The only thing Leo is going to drop is another deposit from shareholders into his bank account"
I keep getting this nagging thought that you are totally right, and that Leo has gotten honest advice from Degado, and the advice is that the OM route is not very productive, an IV for ABSSSI is a nonstarter, that the IBD route is not relevant, and that Kevetrin is too many days late and too many dollars short. Not quite sure I buy this story, but he and a friend keep diluting us out of the game, and nothing changes. A coming half a billion outstanding shares would not get shareholders much, even if something panned out for a 30-40 million sale (and really, how likely is this?). Does this negative narrative include Alfasigma too? I have no idea, but it is all that remains of my realistic hope, I'm afraid. Some mildly hopeful invitro bacterial and viral tests really are so far from products that they are not worth spending too much thoughts on. In other words maybe the attempts at deals with BP, BARDA, etc. have been tried, and nothing has come of it all. And Leo will never be straight with us as long as he can belly up to the paymaster. Sure he has lots of shares, but if he has written it all off, how would he be acting, maybe just like he is now?
PJ, I appreciate your great, positive attitude and the dd time you spend. But wouldn't ipix need a staff to follow up on some of the potential uses of Brilacidin that wide scoped in vitro research uncovers. We are, after all, a shell company with no real staff, no lab, no paid scientific advisors (at least that we are aware of), etc. Nada. That doesn't mean that all hope is gone, but a lot of it is, imo. My cards remain with the N. Italians and the Alfasigma test, at whichever level it is at.
Shoo, I was hoping I missed something big about Brilacidin for OM, or even something small. Or anything at all.
My frustration grows as time passes but no, or at least little useful info is presented to shareholders while the big salaries are continued. Silence has too often been a mask for the incompetent, the lazy, the greedy. Those content to get paid well and provide little in return.
"....but last night I envisioned such an action that would make me again applaud mgt greatly - "
What happened last night?
Since there are no US-based journal articles about Brilacidin for IBD related to Alfasigma, and non US testing is the only testing of Brilacidin that may be going on, it remains shrouded from us. Leo has to have some info, but following from his normal secrecy in most times and places we continue to get none. It would be a happier Easter with just a little new info.
Unfortunately, only Leo knows the whole story. The efficacy numbers were not stellar, and were in fact a bit confusing, but did reflect some potential. But, in a multibillion dollar market even some efficacy with no significant side effects is a good bet. Especially considering there is no real OM treatment other than topical palliatives. And recall, this is a topical not a systemic use of Brilacidin. Still, we can bet BP will have an effective and probably somewhat dangerous immunological drug out sooner rather than later. But where will the money come from for an FDA PH3 for Brilacidin for OM? The only road we have as I see it is a winding one relating to IBD. The longstanding questions re does BP just overlook Briladidn for this use because it has clouded efficacy, or because Leo is a less than ideal CEO/bargainer. Who knows, I sure don't. And the clock runs.
"The Company has also been notified by Alfasigma, its licensing partner, of their intent to initiate this year Phase 2 testing of Brilacidin in Ulcerative Proctitis/Proctosigmoiditis."
A few weeks ago I spent considerable time reviewing the status of the Alfasigma test in Italy. Nothing new, I'm afraid, or at least nothing new that I could find. PJ, if you have something new, please post it.
As I reread my response I see it seems to minimize the often severe pain and damage oral mucositis can cause, especially with the ulcers that can accompany it. That was not my intention. My point remains that as treatments for OM are most often palliative, nonsystemic, and topically applied, the reduction of treatment implied by your use of the term "first pass metabolism" is not quite relevant. Of course, absorption of palliative treatment in an ulcerated area can be enhanced, but has no significant effect on other areas, as the application of Brilaciding is not directed at systemic treatment. As I've said, even a modestly effective, non palliative OM treatment does not really exist, and would make life easier for many head and neck cancer patients, as well as many other chem/rad patients. For a variety of reasons that is not likely to be Brilacidin, though an FDA PH3 would none the less be welcome to patients and IPIX investors alike.
As an aside, I never felt the results were as unassailable as they are sometimes described. I do feel a PH3 is warranted to settle the matter, though I am not expectant of that occurring. If Leo ends up with investment dollars related to the IBD issues, that may be possible (though not necessarily likely).