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TPOOX.tecovirimat the only drug approved for smallpox seems to be the only other antiviral being studied for monkeypox besides Brilacidin.
The FDA is looking at very few options for treating the current viral epidemic of monkey pox as welll as other viral disorders.
https://clinicaltrials.gov/ct2/results?cond=monkeypox&term=&cntry=&state=&city=&dist=
https://www.niaid.nih.gov/diseases-conditions/monkeypox-treatment
Good luck,
Farrell
Sintana's deal for the Namibian assets could be very lucrative if drilling confirms its oil and gas potential.
For 5.7 million dollars Sintana obtained 49% of Inter oil:
Interoil assets
" (i) a 15% carried interest in PEL 87; (ii) a 10% carried interest in each of PELs 82 and 83; and (iii) a 20% carried interest in PEL 90."
" In addition, the completion of the Acquisition is contingent upon the grant of a 90% interest in onshore Block 1918B to an indirect subsidiary of Inter Oil, of which the Company will acquire an indirect 30% interest." { The contingent event described has been completed}
"Three of the four offshore PELs to be acquired are located directly outboard of (i) the Kudu Gas Field, which was the first offshore discovery in Namibia; (ii) Venus-1, a highly anticipated exploration well immediately south of PEL 90, which is proposed to be drilled by French supermajor Total in the fourth quarter of 2021, and (iii) Graff-1, a highly anticipated exploration well immediately south of PEL 83, which is to be drilled by Shell. In addition, Block 1918B is located in close proximity to the prospective block currently being evaluated by Reconnaissance Energy Africa Ltd."
https://www.yahoo.com/now/sintana-announces-execution-definitive-agreement-170900488.html
In addition Interoil's president will assume a board seat on Sintana's BOD
" In connection with the closing of the acquisition, Knowledge Katti has been appointed to the board of directors of Sintana. "
https://www.marketscreener.com/quote/stock/SINTANA-ENERGY-INC-49478488/news/Sintana-Energy-Inc-acquired-49-stake-in-Inter-Oil-Ltd-from-Grisham-Assets-Corp-for-5-7-million-39709855/
Good luck,
Farrell
Correction Brilacidin for OM dose was 45mg/15cc tid
Farrell
Is the ulcerated oral mucosa that different from an ulcerated sigmoid colon?
The oral mucosa does have less surface area than the sigmoid colon ;so based on surface area brilacidin's absorption should be higher through the colon.
The dosage is in the ulcerative colitis study was 200mg while in the oral mucositis study it was only 3mmg per 5cc.So the absorption should be higher in the UC study
In addition the UC patients were given Brilacidin as a retention enema as opposed to the swish and spit BOM study. The time of contact to the mucosa would be much higher in the UC study.
Yet the UC study showed almost no systemic absorption, nanograms.
Just a reminder 1 billion nanograms are in a gram
" Brilacidin was generally well-tolerated and patients maintained stable normal vital signs during treatment..
Measurements of drug concentrations in plasma continued to show limited systemic absorption of Brilacidin, with all values registering less than 100 ng/mL for all six patients in Cohort A and averaging approximately 200 ng/mL maximum concentrations... "
https://www.globenewswire.com/news-release/2017/03/08/933305/0/en/Cellceutix-Releases-Preliminary-Efficacy-and-Safety-Data-in-Interim-Analysis-of-First-Two-Cohorts-in-Phase-2-Trial-of-Brilacidin-for-the-Induction-of-Remission-of-Mild-to-Moderate-.html
When a company is doing its due diligence to partner with IPIX , do you think they will look at actual numbers ?
Indeed !
GLTA,Farrell
Of course, you could be right, but its more likely any associated morbidity is due to the chemotherapy , radiation, cancer, poor nutrition, dehydration, electrolyte imbalances and other complications of the cancer and its treatment ...as well as the the oral mucositis.
Besides, we all know Brilacidin is not absorbed systemically.
Try again
GLTA,
Farrell
It has been widely reported that the Soviet Union has developed the ability to dispense Marburg virus from missiles.
Another reason to develop Brilacidin as an antiviral.
https://www.globalsecurity.org/wmd/intro/bio-marburg.htm
In the 1980s, the Soviet Union experimented with the Marburg virus in aerosol form on monkeys and determined that infection required only a few virions. Ken Alibek (formerly Kanatjan Alikbekov) who secretly immigrated to the United States in 1992 revealed information about Soviet experimentation with the Marburg virus. The former First Deputy Director of Biopreparat, the Soviet biological weapons program, Dr. Alibek reported that Soviet scientists were researching whether Marburg could be loaded into a warhead or a MIRV delivery system.
GLTA Farrell
Interesting review of the economics of the Jaca well
https://ihsmarkit.com/research-analysis/can-jaca-turn-sao-tome-and-principe-into-new-oil-producer-with.html
GLTA,Farrell
It is unlikely the Russians will end oil supplies to Europe. I agree with JP Morgan a more likely scenario is for the Russians to reduce production globally. No one has the excess capacity to counter Russian oil cuts of several million barrels...not even OPEC.
Meanwhile the US restricts the release of drilling leases.
https://www.bloomberg.com/news/articles/2022-07-01/jpmorgan-sees-stratospheric-380-oil-on-worst-case-russian-cut
GLTA Farrell
Thanks for copying and posting the purchase of IPIX preferred stock and warrants by Kips Bay.
As you pointed out it was a good deal for Kips Bay with little incentive to hold them any longer than the restrictions listed in the terms of the sale.
The questions now are when did Kips Bay convert the preferred to commons shares and when did they sell the common shares and warrants.
Unless you know the above you can not know if the increase Kips Bay holding is a purchase or conversion of preferred shares. While I have not been able to determine the time of conversion of the preferred or the sale of the commons shares and warrants Kips Bay reporting does give clues.
Kips bay reported owning 4.97% [21.2 million} IPIX common shares 0n 5/3/21.
https://sec.report/Document/0001213900-21-024168/
On 7/5/2022 Kips Bay reported owning 9.9% [45 million} of IPIX common shares.
https://sec.report/Document/0001213900-22-037187/
Investopedia confirms common and preferred shares are included in ownership calculations.
It appears there is more evidence for a 23 million share stock purchase by Kips Bay rather than a conversion of preferred shares.
Good luck,Farrell
Innovation Pharmaceuticals Inc. Common Stock (QB)
$0.0485 0.01 (52.03%)
Bid/Ask
0.043 / 0.0485
Volume
1,084,222
Up 52% I am looking forward to more good news.
GLTA,Farrell
Impact Oil & Gas prepares to sell stake in Namibian offshore block
LONDON, June 6 (Reuters) - Impact Oil & Gas is considering selling its 20% stake in a large block in deep water off the coast of Namibia where TotalEnergies (TTEF.PA) made a significant oil discovery this year, four industry sources told Reuters.
Impact, which is privately owned and focused on exploration in Africa, has hired investment bank Jefferies to prepare a sale process for its stake in Block 2913B, which is estimated to be worth $500 million to $1 billion, the sources said.
https://www.reuters.com/markets/europe/impact-oil-gas-prepares-sell-stake-namibian-offshore-block-sources-2022-06-06/
GLTA, Farrell
Squalus, IPIX's partner, is planning to have the new system evaluated by the FDA 510k path.
IMO the system is likely to use a laser already approved for human treatment, since the PR did not mention a new laser.
In addition laser treatments have been performed for a number of years for all the indications indicated in the PR, epilepsy and tumors of the brain, lung,prostate,breast and liver.
The Squalus laser system may be viewed by the FDA primarily as an imaging and software change to better direct the laser treatment and as such may require a much shorter path to the 510k approval.
Investors will have to wait until these points are clarified by the FDA and Squalus.
https://www.fda.gov/media/99785/download
The quote below does not apply to the Squalus system since it is applying for the 510k designation. It is placed here to show software changes are held to a different level of scrutiny.
"Many software functions are not medical devices (meaning such software functions do not meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)), and FDA does not regulate them as devices."
https://www.fda.gov/media/80958/download
Good luck, Farrell
A better way to link article:
https://www.sciencedirect.com/science/article/abs/pii/S0960894X20308386?via%3Dihub
Click box at top...View Open Manuscript
GLTA, Farrell
A drug library [? HDP antifungals discovered by Polymedix} was screened for antifungal activity. in this 2017 report. One of these drugs,C4. was studied for effects against Canidia albicans. and was found to have "potent" anti fungal effects
Note disclosure at end of article:
"Dr. Scott owns stock in Cellceutix, Inc., which owns the patent on compound C4."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5489528/
GLTA,
Fareell
Dr Scott's publication of antifungal research seems to be an extension of the Polymedics HDP development program,
"We have developed a series of non-peptide analogs of the host defense proteins (HDP mimics,
smHDPs) as antimicrobial agents that have distinct advantages over peptides for pharmaceutical use
[16, 17]. The overarching goal of our approach is to recapitulate the biological and structural properties
of HDPs into oligomeric backbones without trying to duplicate the dimensional structures of the
peptides but rather by creating small structurally constrained cationic compounds. These smHDPs have
better pharmacokinetic and tissue distribution properties than peptidic HDPs due to their smaller size
and improved stability; and are less expensive to prepare with the selection of appropriate building
blocks. Furthermore, synthetic chemistry, expanded beyond amino acids, provides considerably more
chemical space to fine-tune structures for enhanced antimicrobial activities and minimized toxicity."
Note reference #16 and 17
JMO,
Farrell
https://pdf.sciencedirectassets.com/271398/1-s2.0-S0960894X20X00254/1-s2.0-S0960894X20308386/am.pdf?X-Amz-Security-Token=IQoJb3JpZ2luX2VjEGkaCXVzLWVhc3QtMSJIMEYCIQC1iZtNywpl%252FQXVFfkGhOHr8wc%252Bsbq%252BedTQfgdsaVI21wIhALTNuyCSKA0ShgjxIb55S3nq9pdrVr%252BVkp7cXaTvAcy%252FKtIECGIQBBoMMDU5MDAzNTQ2ODY1IgwJF%252FKKusKtL%252FN%252BcakqrwRQa3smHiGckr5qIPzBVYYwZmNUuHmG4D23MW4Gvn1luWcDPww81ugv4eABN0g3XMsqrIOC5v7qiXN33s54Hj2HVZTGk5bEImaEupIsQDe9meNFuNwIjww%252FlH7AmdmAxvIdjJMqZgcpUggVTKb7LvK6CVcxc9QMo%252FKmq0Mxi3Dfpnoi1DPnZPCZvwiumf1%252B6MkoBIByXMvpa7OI74%252F7CHsRaQpWu%252BYs5pYQaZR%252Br6LYzR3b85BZ3Efs70L1ZIoGpXZYUb9OsLTlie2qmNmuNjJlp5wIdfsLafdBqbpEr7%252FIfBkTYsqdyyYvDIXSvWO2Jp6FqP4BnoxQg%252B9CcGpcri2ldGDnqNzJ7peAlD93EQPLTUHA4REl455BRpW%252FsEz%252FoYZmVFLw%252FDsTvg6gLjDILUGZFq20UtY7MO32EDvpZQkZ6Fxh6wBOiruLYhE9sQqyB6vPM6FNBu%252F3giacyf5tykXIJGI08qNdRkXUfRVon5YYn%252BRGxVj3oyA8ZC%252F%252FSPQCdFih79hNRz%252B0Uh%252BUVFQwllsbwhO7tmAdGnHfswcdQQReqsKW3Q4lBukxe%252FS9%252FWcWkkHQ2MRZHufGJ%252F1mVwvHCMj6D3M%252Fzpc9nhfJ79BVY%252BjByO0zrHnL9ku80ApKJ2V1ygovl83Cnd2%252FmNccpBBLBeqjMNu8HHmKT9fFtSeP3sQlQFvEpqtQby4NGMGXiSvawS%252BeSwI6Qf6X7efcOcXYQD27ZG0c16uBi6DBHn0vpId9MMDX45QGOqgBgcVZb7vdaJC7chP5sLBhqLwUCqD7sBNX4fdL%252FYvYjsh33GgvBCPNJlA%252BtpDVG5BeYuN6ssdfKPdH2lbkx7Q4oiloyncR%252BOPwSwn7F9O7qImFY5q8dix%252Bmwpk%252BtDvcX74Dsd%252Fjb76xNsRgZ%252FqdwMZyuHvnasHuU4KAMeK5w6yYtlzyaSg7ymK90QUSLlA1oaym0HWzJRipOEeWDpZvafSoJ3b21CurNKa&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Date=20220602T175927Z&X-Amz-SignedHeaders=host&X-Amz-Expires=300&X-Amz-Credential=ASIAQ3PHCVTYWRRMRMEN%252F20220602%252Fus-east-1%252Fs3%252Faws4_request&X-Amz-Signature=922490a70f254a920cd37c57d4e544ca643d9a66fec5df042127a5057f07f70
AOIFF owns 6% through Impact oil.
"AOI) (Africa Oil Corp. ("AOI", "Africa Oil" or "the Company") is pleased to note the press release by TotalEnergies, the operator of Block 2913B, offshore Namibia. Africa Oil has an indirect interest in this block through a 30.9% shareholding in its investee company Impact Oil & Gas Limited ("Impact") with a 20% working interest in the block."
https://www.yahoo.com/now/africa-oil-announces-major-light-083000464.html
GLTA,
Farrell
Plus ERHC may claim its 15% of 2 EEZ blocks ...
"ERHC will decide whether to take up the option to acquire up to a 15% paid working interest in each of two additional blocks of the EEZ when called upon to exercise the option by the Government of STP in accordance with the agreements which provide for the rights and option."
Farrell
Big buys into close. Last trade at .044
Unusual activity as last trades of week.
News pending ??? Or more jerking around???
Time will tell.
GLTA Farrell
Today in Upstream: Africa Oil eyes wildcat on red-hot Orange basin block in South Africa
Deepwater Block 3B/4B could host 3 bn barrels of oil and 1.5 Tcf of gas in just three prospects.
GLTA,Farrell
You are ignoring the fact
every covid antiviral was studied on the hospitalized moderate to severe patients first. Do your homework.
Glta, Farrell
I believe the government, FDA,and NIH are now and have been desperate for an antiviral effective against Covid . The biggest need is for hospitalized patients with severe pulmonary failure. The death rate with mechanically ventilated Covid patients is between 80% to 90%.
At the time IPIX had their meeting with the FDA the Covid infection, hospitalization and death rate were escalating.
It would be in any drug company's financial interest to begin their Covid drug studies on patients with the highest chance for
success, patients with mild disease, but in this setting that was not possible for Brilacidin or any covid therapeutic.
I have no direct information on IPIX's meeting with FDA, but I do understand the tremendous political and humanitarian pressure to help the covid patients who were the sickest with the highest death rate. I also know virtually every antiviral drug's initial clinical trial was on the moderate to severely ill hospitalized covid patients.It is clear to me the only possible option the FDA gave IPIX was to study Brilacidin on the moderate to severe hospitalized covid patient
Even though the Covid infection rate is now falling, the death rate has remained surprisingly high. The NIH,FDA and the government are still desperate to find better treatments for Covid. The government seems interested in studying therapeutics in its fully funded ACTIV trials. Now the Biden administration is funding a 3 billion dollar program for Covid and antiviral treatments.
https://www.niaid.nih.gov/news-events/biden-administration-invest-3-billion-american-rescue-plan-part-covid-19-antiviral
https://www.nih.gov/research-training/medical-research-initiatives/activ/covid-19-therapeutics-prioritized-testing-clinical-trial
I believe the latest PR will lead to Brilacidin being funded for another covid trial as outlined by Mr Ehrlich:
"Given the need for development of new small molecule antivirals and immunomodulators, the Company is planning to submit Brilacidin for possible inclusion in government-sponsored COVID-19 trial platforms, e.g., the NIH ACTIV program. Platform trials, which typically enroll hundreds of patients per treatment arm, can more accurately evaluate the treatment potential of COVID-19 drug candidates. Pursing a biomarker-driven approach, increasing Brilacidin dosing and treatment duration, targeting different patient populations, testing Brilacidin in combination with drugs exhibiting different mechanisms of action (e.g., remdesivir, given strong synergistic in vitro data)—all are possible elements of any future Brilacidin COVID-19 trial design. Compassionate use of Brilacidin also is anticipated to continue, which could further inform Brilacidin’s treatment effects in COVID-19. For more details on the Company’s Compassionate Use policy, please visit:
https://www.ipharminc.com/expanded-access-and-compassionate-use
The Company also plans to seek additional clinical development support from the NIH Antiviral Program for Pandemics (APP). Brilacidin for prophylactic use, including assessing Brilacidin in pre-clinical animal models, is of particular interest due to Brilacidin’s blocking and neutralizing antiviral properties and industry investment in developing intranasal-targeted, direct-acting antivirals. Preliminary Brilacidin formulation work for inhaled delivery has been conducted, with the NIH APP a potential avenue to expand on this work, along with exploring the subcutaneous administration of Brilacidin, which has greater than 70 percent bioavailability via this route of administration."
GLTA,Farrell... all in my opinion
Its hard to respond to a post so poorly written.
If you could review your post and clearly state what your point is, I will make an appropriate response.
GLTA Farrell
It is all in the PR for those who care to read it:
https://www.ipharminc.com/press-release/2022/3/7/innovation-pharmaceuticals-reports-additional-findings-based-on-review-of-brilacidin-phase-2-covid-19-trial-results-and-compassionate-use-cases
“These results, along with observations on the compassionate use of Brilacidin in COVID-19 related to dosing, as well as data being generated from ongoing scientific collaborations, are informing paths forward for our Brilacidin antiviral program. We believe Brilacidin has merit to help address COVID-19 and can play a role in preparing for future pandemics, given Brilacidin’s unique immunomodulatory and antiviral properties. Progress in the Brilacidin antiviral program largely will be dependent upon obtaining government funding for additional clinical development and leveraging external research relationships. "
Glta,
Farrell
JMO I am very optimistic IPIX will receive government funding.
As per the PR, Mr Ehrlich is working to accomplish that goal.
Glta, Farrell
If Remdesivir can have disappointing results in its clinical trial and still be the Covid drug of choice for Covid for many months, why should IPIX not further study Brilacidin for other indications?
After all all the antivirals, convalescent serum, monoclonal antibodies and other drugs studied as antivirals for moderate to severe Covid in hospitalized patients failed their trials. Many of those drugs were shown to be effective in other indications such as prophylaxis in high risk patients and mild Covid.
I am encouraged IPIX is studying Brilacidin inhalers and subcutaneous injections for use as other treatment modalities.
IMO Brilacidin should be studied for use in the subgroups where efficacy has been suggested in the statistical review of the phase 2 study.
If Brilacidin may prevent a certain percentage of the hospitalized Covid patients from progressing, it would be criminal not to fully study it.
GLTA, Farrell
Thanks for posting. Of course Anthrax is not a virus, but a bacteria ,bacillus anthracis, which has the potential to be a bioweapon.
https://www.cdc.gov/anthrax/bioterrorism/threat.html
It is easy to see why the Department of defense would be interested in aa potent antiviral and antibiotic such as Brilacidin.
Good luck to all,
Farrell
You have to admit it is a much better way to handle the trial data than the Remdesivir trial where the FDA and Gilead changed end points in mid trial
Plus Remdesivir has been used to treat millions with covid.
https://www.statnews.com/2020/05/05/were-researchers-wrong-to-move-the-goalposts-on-remdesivir-in-the-end-it-may-not-have-mattered/
Good luck, Farrell
My take is the results are good enough for future government funding of an additional stage 2-3 NIH trials. The results suggest Brilacidin at higher doses and longer duration may provide additional benefit,both as an antiviral and anti inflammatory.
In addition Brilacidn for prophylaxis and in less ill patients befire hospitalization may prove beneficial.
Compare Brilacidin's results to the therapeutics studied in the ACTIV trials and I think most will agree Brilacidin deserves similar study.
https://www.nih.gov/research-training/medical-research-initiatives/activ/covid-19-therapeutics-prioritized-testing-clinical-trials
GLTA Farrell
Thanks for posting the reminder about the ADE concern.
GLTA,Farrell
Generally the US health statistics are less reliable because all 50 states collect data and report it in different ways. Most of the data comes from county health departments which vary greatly in reliability. It is even worse for covid because the outbreaks are regional and spread over weeks which distorts the reporting.
The article I posted reflects the confusion in making public health decisions from US data. It also shows the difficulty in making personal health decisions based on the very incomplete data and inconsistent advice given by the CDC.
A good example is the recent CDC advice which allows healthcare workers who have contracted covid to return to work immediately in a crisis situation at their health care institution.
Unfortunately health care staffing is frequently at a crisis level which means the nurse doctor or staff person taking care of you or your family could have active,contagious Covid.
https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html
The best covid statistics in my experience are from Israel and the United Kingdom.
GLTA, Farrell
Mysteries of Covid vaccinations: Why are so many Americans still dying of Covid
https://nymag.com/intelligencer/2022/02/why-are-so-many-americans-still-dying-of-covid.html?utm_source=pocket-newtab
"Why are so many Americans still dying of COVID? The seven-day average is now 2,500 a day, higher than at any point in the last two years outside last January — before vaccines, at the height of the most devastating phase of the pandemic. Yesterday, the total reported dead was 3,600."
A good review of confusing vaccine statistics is presented. The review does present various possibilities of why so many are dying in spite of increasing numbers of Americans being vaccinated,but no real answer yet.
Just my opinion: While no doubt exists being vaccinated does reduce the rate of hospitalizations and death; the vaccines do not work well enough even in the face of a less pathologic covid variant,Omicron, to reduce a frighteningly high death rate.
Just don't tell me therapeutics are not needed.
GLTA Farrell
"Only effective ones who haven't failed an FDA trial."
But, that's the problem isn't it.
All of the antivirals for hospitalized Covid patients with moderate to severe covid have failed.
OK, except for Remedesivir which was shown to shorten hospital length of stay. And, it achieved its primary end point ...after the primary end point was changed in the middle of the trial.
How did the makers of Remdesivir, Regeneron's anti covid antiviral, Molnupiravir,ritonavir respond to failing their initial trial against covid?
Did the other companies stop their studies. No they changed to study their drugs at earlier states of covid infection...for viral prophylaxis and mild infection.
You are right that anyone dying from Covid-19 is a tragedy. Covid patients need better treatments.
GLTA,Farrell
NIH combo trials?...
During the Ebola outbreaks, HIV epidemic and hepatitis c when vaccines and single antivirals either did not work, worked poorly, or were not practical studies were shifted to combination trials of antivirals.
Examples of combination antivirals :
1.Zmapp a combination of 3 monoclonal antibodies for Ebola,
2.Triple antivirals for AIDS
3.Hepatitis c where sofosbuvir and ribavirin may be used in combination
The combination antivirals produced life saving treatments for deadly diseases.
The combinations often are changed and optimized with time as new drugs are developed.
Why has the NIH and FDA been slow to promote more combination antivirals against Covid?
That is a good question.
I can not think of a good reason why combination antiviral studies for Covid have not been a priority.
GLTA, Farrell
While vaccination lowers the risk of death and hospitalization, it may not lower the risk of catching Covid and it does not eliminate the risk of dying from Covid, even in the triple vaccinated.
Therapeutics are still needed.
Israel a country where Covid vaccination is almost universal. Below are reports from January 2022.
"The Health Ministry updated its coronavirus figures on Friday, revealing that nearly 70,000 Israelis tested positive for COVID-19 the day before, with the number of patients in serious condition climbing to 638.
Total active cases rose to 427,023 and 1,758 Israelis were hospitalized in all, with 123 of them on ventilators.
At least 9,867 medical staff were sidelined after contracting COVID themselves, including 1,379 doctors and 2,916 nurses, the ministry said."
https://www.timesofisrael.com/israel-sees-70000-new-covid-cases-with-638-hospitalized-in-serious-condition/
"On Wednesday, the Israeli government reported that a record 11,978 new infections were registered the day before. That beats the previous high of 11,345 infections in a single day set Sept. 2 during the Delta variant wave."
"Israel also is on the cusp of making available drugs that could help people in at-risk groups avoid severe infections."
"There is no control of the Omicron wave,” Sharon Alroy-Preis, the Israeli Health Ministry’s top public health official, said on Israel’s Channel 13 this week."
"The Health Ministry updated its coronavirus figures on Friday, revealing that nearly 70,000 Israelis tested positive for COVID-19 the day before, with the number of patients in serious condition climbing to 638.
Total active cases rose to 427,023 and 1,758 Israelis were hospitalized in all, with 123 of them on ventilators.
At least 9,867 medical staff were sidelined after contracting COVID themselves, including 1,379 doctors and 2,916 nurses, the ministry said."
https://www.latimes.com/world-nation/story/2022-01-05/israel-all-time-high-covid-infections-fourth-vaccine
Since the vaccines do not eliminate deaths or hospitalization, what will we do for the next variant which may be more deadly than Omicron. Are we going to give a 4th vaccine like the Israelis? Will it make sense to give the 5th, 6th or 7th vaccine booster?
IMO this is the time to develop therapeutics.
GLTA, Farrell
King, this is the 8K from 9/2021. By my reading it says ERHC has 100% interest in EEZ blocl 4 and the other party has withdrawn its claim.
Can you repost your evidence?
GLTA,
Farrell
"An arbitration holding in London, England, under the auspices of the International Chamber of Commerce, between a foreign multinational and ERHC Energy Inc. (together the “Parties”) has been concluded by the withdrawal of further claims and the entry of a final award (“Final Award”) by the sole arbitrator.
2.
The arbitration concerned an assignment agreement (“Agreement”) and a deed of assignment (“Deed”) entered into on October 17, 2017, between the Parties.
3.
The sole arbitrator had on August 15, 2018, rendered a partial award (“Partial Award”) which held that as of the date of the Agreement and Deed, ERHC Energy Inc. is and was the legal and beneficial owner of a 100% working interest in Block 4 of the Exclusive Economic Zone, offshore Sao Tome and Principe. The Partial Award also upheld the foreign multinational’s rights and interests by virtue of the Agreement and Deed as valid and enforceable.
4.
The Partial Award was upheld by, and constituted into, the judgment of the High Court of Justice of England and Wales on January 4, 2019.
5.
The Final Award, which has just been delivered in 2021, upheld the withdrawal of all other claims in the matter, made orders as to the sharing of costs between the Parties and ends the matter with finality. "
End of phase 2 meeting from ProPharma Group:
IMO application to an ACTIV trial would require a end of phase 2 meeting with the FDA.
End of Phase 2 (EOP2) Meetings
What is the Purpose of the End of Phase 2 Meeting with the FDA
Following your Phase 2 clinical trials, you will need to review and obtain agreement from the FDA on your study designs for Phase 3. This is the purpose of the End of Phase 2 (EOP2) Meeting with FDA, in which you’ll need to effectively present your Phase 3 and submission strategy and ensure that you are aligned with the FDA prior to the start of Phase 3.
During this meeting, FDA will determine whether it’s safe to proceed to Phase 3. They will evaluate your Phase 3 plans and protocols along with your existing studies to assess effectiveness, and they’ll note if any additional information is necessary to support the marketing application. The End of Phase 2 Meeting is a critical milestone in your development program, so it’s important to prepare in order to make sure you leave with plenty of helpful feedback.
Who is Eligible for an End of Phase 2 Meeting?
The EOP2 Meeting with the FDA is typically for Investigational New Drugs (INDs) which involve new molecular entities or major new uses of marketed drugs. However, a Sponsor of any IND may request an EOP2 Meeting with FDA in preparation for Phase 3.
When Should the End of Phase 2 Meeting occur?
As the name implies, the EOP2 Meeting should occur at the end of Phase 2 clinical trials. Furthermore, the meeting should occur before serious resource commitments are made towards Phase 3. However, the EOP2 Meeting should not delay the transition from Phase 2 to Phase 3, which is why planning and preparation are critical.
Preparation for End of Phase 2 Meeting
To move you to the next clinical trial phase, ProPharma Group will diligently work with you to prepare for the EOP2 Meeting. With your input, our experts will:
Develop the EOP2 briefing package to be sent to FDA in advance of the meeting
Request the EOP2 Meeting
Determine meeting objectives and agenda and script the participants
Conduct a meeting rehearsal at our offices in Washington, DC
Attend the meeting with you and summarize results in formal notes
Conduct a debriefing session to discuss the accomplishment of meeting objectives and finalize meeting minutes to be sent to the FDA
https://www.propharmagroup.com/regulatory-affairs/end-of-phase-2-eop2-meetings/
https://www.lawinsider.com/dictionary/end-of-phase-2-meeting
GLTA,
Farrell
At this point the final review of the phase 2 study of Brilacidin for Covid has not been announced.
IPIX has stated entering the fully funded NIH ACTIV trials as a goal for Brilacidin.
As you know the next step for IPIX is planning its end of Phase 2 meeting with the FDA. IPIX has stated it will also review analysis of the compassionate use data which has not been released in addition to the final analysis of the Phase 2 data.
"The Innovation team is working with biostatistics partners to explore the data—conducting deeper analysis of different subgroups by patient demographics and baseline characteristics, domestic versus overseas COVID-19 standards of care, and more—to potentially identify meaningful patterns and positive trends. Analysis of the compassionate use of Brilacidin in the U.S. in critically-ill COVID-19 patients who had exhausted all other therapeutic options also is planned. Changes to biomarkers and positive clinical changes were observed, with some compassionate use patients administered Brilacidin more frequently and over a longer duration than patients in the Phase 2 Brilacidin COVID-19 trial. Collectively, these actions will help inform next steps for Brilacidin against COVID-19 in the coming year"
Law insider defines the end of phase 2 FDA meeting as follows:
"End of Phase 2 Meeting means a meeting with FDA, the purpose of which is to determine the safety of initiating a first Phase III Clinical Study, to evaluate the Phase III Clinical Study plan and protocols and the adequacy of current studies and plans to assess pediatric safety and effectiveness, and to identify any additional information necessary to support a Drug Approval Application for the uses under investigation, as further defined in 21 C.F.R. 312.47(b)(1), as amended from time to time..."
The phase 2 interim safety data was satisfactory in the Phase 2 study for Brilacidin for Covid which allowed the dosing to be increased to 5 days.
The answers to your questions are all here:
http://www.ipharminc.com/press-release/2021/12/7/innovation-pharmaceuticals-analyzing-full-dataset-for-its-brilacidin-covid-19-clinical-trial-company-evaluating-new-pipeline-opportunities-for-2022
http://www.ipharminc.com/press-release/2021/11/18/innovation-pharmaceuticals-provides-brilacidin-program-update
http://www.ipharminc.com/new-blog/2022/1/25/shareholder-alert-upcoming-update-on-brilacidin-in-covid-19
GLTA,Farrell
Here the list of all the medications in the Activ trials to date.
https://www.nih.gov/activ/nih-funded-activ/activ-associated-clinical-trial.
As you can see it includes repurposed drugs like Aspirin and Ivermectin as well as the latest monoclonal antibodies. Most of the drugs are anti-inflammatories. A few are antivirals.
When you review the list, it is not impressive.It is surprising how few drugs are left to be tested against Covid. These drugs are a last ditch effort by the NIH to find any drug with any degree of efficacy against Covid.
Let me know if you find one with where government sponsored in vitro testing against Covid produced a selectivity index of 426.
I believe IPIX, as it has stated publicly, is actively pursuing inclusion in the ACTIV trials. I believe it is important to pursue the Activ testing of Brilacidin against Covid by itself and in combination with different drugs at different stages of Covid. Of course the NIH will make the decision
GLTA,
Farrell
11/12/2021 PR
"Complete analysis of trial results already has begun, with the aim to potentially identify positive trends in the data that could support Brilacidin for inclusion in larger COVID-19 platform trials, such as the U.K.’s CTAP program and the NIH’s ACTIV program. The purpose of these programs is to prioritize development of promising COVID-19 therapeutics."
12/7/2021 PR
"The Company is pleased to report that as of last week it had received all unblinded data/data outputs from the recently completed Phase 2 clinical trial of Brilacidin for treatment of moderate-to-severe COVID-19 in hospitalized patients. The Innovation team is working with biostatistics partners to explore the data—conducting deeper analysis of different subgroups by patient demographics and baseline characteristics, domestic versus overseas COVID-19 standards of care, and more—to potentially identify meaningful patterns and positive trends. Analysis of the compassionate use of Brilacidin in the U.S. in critically-ill COVID-19 patients who had exhausted all other therapeutic options also is planned. Changes to biomarkers and positive clinical changes were observed, with some compassionate use patients administered Brilacidin more frequently and over a longer duration than patients in the Phase 2 Brilacidin COVID-19 trial. Collectively, these actions will help inform next steps for Brilacidin against COVID-19 in the coming year, while Brilacidin’s broad-spectrum antiviral properties continue to be researched through NIH and other scientific collaborations."
1/25/2022
"Upcoming Update on Brilacidin in COVID-19"
"Collaborative work with NIH and other researchers on Brilacidin’s broad-spectrum antiviral properties is ongoing and generating promising data, with future updates planned."
A common thread it the 2 PR's and the share holders letter are Brilacidin and the NIH
Could the promise of an update on Brilacidin in Covid 19 be in regards to the inclusion of Brilacidin in the NIH's fully funded ACTIV trial for Covid19 therapeutics?
You have to decide for yourself.
If Brilacidin is to be included in the fully funded ACTIV therapeutics trial IPIX's share price is much too low.
Stay tuned.
JMO
GLTA,
Farrell
Thanks for reposting the link to the abstract.
Farrell