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$TSN.CN Tracesafe useful tool vs COVID 19
Hey everybody, as we venture through these murky waters, we need solutions to mitigate this problem. Let me know what you think of these wearable bracelets that are big in Asia.
Big deaths in nursing homes. Expect many to adopt tracing methods. Some elder homes are having visitings traced so as to mitigate covid or other infection spreads. Expect luxury nursing homes to move quicker and government run ones not far behind
[url][/url][tag]https://www.theglobeandmail.com/canada/article-new-data-show-canada-ranks-among-worlds-worst-for-ltc-deaths/[/tag]
$SBFM is working hard towards delivering vital Anti-Coronavirus pharmaceuticals which are needed right now more than ever.
Sunshine Biopharma Believes That an Effective Coronavirus Treatment Continues to Be Necessary
MONTREAL, QC / ACCESSWIRE / November 24, 2020 / Sunshine Biopharma Inc. (OTC PINK:SBFM), a pharmaceutical company focused on the research, development and commercialization of oncology and antiviral drugs today announced that it is pushing ahead with its Anti-Coronavirus drug development program. While the recent announcements about effective vaccines on the horizon is a cause for celebration, Sunshine Biopharma believes that a treatment for Coronavirus infections continues to be essential for any robust healthcare system. This is particularly important in view of the fact that gaps and lapses will likely occur during vaccine implementation and people may fall ill and require treatment. In addition, a treatment that can be taken orally at home, much like an antibiotic, would be an ideal complement for vaccination.
https://www.accesswire.com/users/newswire/images/618111/sunshine.png
"SARS-CoV-2, the causative agent of COVID-19, is the third in a line of Betacoronaviruses that have caused serious human health threats in the past. The first two were SARS-CoV that appeared in 2002 and MERS-CoV in 2015," said Dr. Steve N. Slilaty, CEO of Sunshine Biopharma. "There is nothing that says that another Betacoronavirus with a potential for causing yet another serious threat to human health won't appear in the future. It is critical for us to have a treatment for today and as part of our preparedness for the future," he added.
About Sunshine Biopharma's Coronavirus Treatment
Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) is the causative agent of COVID-19, the current ongoing pandemic that has claimed the lives of over 1.3 million people worldwide since it first appeared in December 2019. There are currently no drugs that can effectively arrest replication of the virus in people who have contracted the illness. On May 22, 2020, Sunshine Biopharma filed a provisional patent application for a library of molecules which were designed to inhibit the Coronavirus proteases, thus shutting down the ability of the virus to multiply and cause illness. Sunshine Biopharma has since screened the library and identified a lead Anti-Coronavirus compound (SBFM-PL4). The Company is currently conducting a series of in vitro tests to evaluate its specific inhibitory activity of SBFM-PL4 against the SARS-CoV-2 papain-like protease (PLpro), one of two Coronavirus encoded proteases essential for viral replication. Following the initial in vitro studies, SBFM-PL4 will be moved forward to the cell culture testing stage and assessment in Coronavirus infected mice before entering human clinical trials.
About Sunshine Biopharma
In addition, to working on the development of a treatment for COVID-19, Sunshine Biopharma is engaged in the development Adva-27a, a unique anticancer compound. Tests conducted to date have demonstrated the effectiveness of Adva-27a at destroying Multidrug Resistant Cancer Cells, including Pancreatic Cancer cells, Small-Cell Lung Cancer cells, Breast Cancer cells, and Uterine Sarcoma cells. Clinical trials for Pancreatic Cancer indication are planned to be conducted at McGill University's Jewish General Hospital in Montreal, Canada. Sunshine Biopharma is owner of all patents and intellectual property pertaining to Adva-27a.
Safe Harbor Forward-Looking Statements
This press release may contain forward looking statements which are based on current expectations, forecasts, and assumptions that involve risks as well as uncertainties that could cause actual outcomes and results to differ materially from those anticipated or expected, including statements related to the amount and timing of expected revenues statements related to our financial performance, expected income, distributions, and future growth for upcoming quarterly and annual periods. These risks and uncertainties are further defined in filings and reports by the Company with the U.S. Securities and Exchange Commission (SEC). Actual results and the timing of certain events could differ materially from those projected in or contemplated by the forward-looking statements due to a number of factors detailed from time to time in our filings with the SEC. Among other matters, the Company may not be able to sustain growth or achieve profitability based upon many factors including but not limited to general stock market conditions. Reference is hereby made to cautionary statements set forth in the Company's most recent SEC filings. We have incurred and will continue to incur significant expenses in our expansion of our existing as well as new service lines noting there is no assurance that we will generate enough revenues to offset those costs in both the near and long term. Additional service offerings may expose us to additional legal and regulatory costs and unknown exposure(s) based upon the various geopolitical locations we will be providing services in, the impact of which cannot be predicted at this time.
For Additional Information:
Sunshine Biopharma, Inc.
Camille Sebaaly, CFO
Direct Line: 514-814-0464
camille.sebaaly@sunshinebiopharma.com
http://www.sunshinebiopharma.com
SOURCE: Sunshine Biopharma Inc.
View source version on accesswire.com:
https://www.accesswire.com/618111/Sunshine-Biopharma-Believes-That-an-Effective-Coronavirus-Treatment-Continues-to-Be-Necessary
https://www.google.com/amp/s/seekingalpha.com/amp/news/3637359-mymetics-secures-swiss-grant-to-advance-virosome-based-covidminus-19-vaccine
https://www.biospace.com/article/releases/mymetics-corporation-update
Innosuisse unterstützt ein weiteres Innovationsprojekt im Kampf gegen #Covid19. Unterstützt werden Forschungsarbeiten zu einem virosomalen Impfstoff, der direkt im Bereich der Nasenschleimhaut aufgebracht werden soll. https://t.co/eACm4cPN0G
— Innosuisse (@Innosuisse) November 18, 2020
nice. i'll check that out as well.
Will do watch the pop RVVTF is about to have double bottom last week. Phase 3 Bucillamine CV-19 drug data read out soon extreme low side effects and easy to scale.
$RVVTF
i like $CYDY.. also looking at private company that has impressive developments.. they have a presentation (raising money for approved phase 3 trials) later today..
COVID-19 & Current Economic Crisis
Mon, Nov 16, 2020 2:00 PM - 3:00 PM (PST)
Please join my meeting from your computer, tablet or smartphone.
https://www.gotomeet.me/patrickimeson/covid-19--current-economic-crisis-87
Nice Doji put in this week looks like a double bottom put in lots of catalysts this gets emergency approval for CV-19 with interim results from a Phase 3 next month only a handful of companies in Phase 3 for a therapeutic for CV-19 Looking for a new 52 week high.
$RVVTF
Maybe. Good spec play.
Phase 3 FDA Covid Trial one of a few drugs in Phase 3
Study Description
Brief Summary:
This is a Phase 3, multi-center, randomized, double blind, placebo controlled, clinical study of bucillamine (2 dosage levels) in patients with mild-moderate COVID-19. Patients will be randomized 1:1:1 to receive bucillamine 100 mg 3 times a day (TID), bucillamine 200 mg TID or placebo TID for up to 14 days. After the first interim analysis when a single dose is selected, patients will then be randomized 2:1 to the selected bucillamine dose or placebo The study will be overseen by an independent Data and Safety Monitoring Board (DSMB). Up to 10 centers in the United States will conduct this study. Up to 1000 patients will be enrolled in this study. Patients will participate in the study approximately 45 days.
https://www.clinicaltrials.gov/ct2/show/NCT04504734?term=Bucillamine&cond=Covid19&draw=2&rank=1
CYDY 1.5 Billion Market cap Phase 2 CV-19 went from .26 to $10.00
RLFTF 1 Billion Market cap Phase 3 CV-19 Drug
RVVTF 40 Million market cap .18 cents Phase 3 CV-19 interim results by end of Dec 2020 low side affects for Bucillamine and cheap to manufacture at scale.
$RVVTF
Vaxil (VXLLF) Enters Into a Cooperative Research and Development Agreement With U.S. Army Medical Research Institute of Infectious Diseases ("USAMRIID")
VAXIL BIO LTD. ("Vaxil" or the "Company") (TSX VENTURE: VXL), an innovative immunotherapy biotech company specializing in cancer and infectious diseases, is pleased to announce that on October 26, 2020, it has entered into a cooperative research and development agreement (CRADA) with USAMRIID under which USAMRIID will test CorVax(TM) for its ability to specifically prevent COVID-19 in mice.
Vaxil recently reported that its CorVax(TM) successfully generated an immune response in the experiment carried out at the Allergy and Clinical Immunology Unit at the Medical Research, Infrastructure, and Health Services Fund of the Tel Aviv Sourasky Medical Center in Israel by Dr. David Hagin. As a result, the Company is progressing to the next study to test whether this immune response is specific enough to COVID-19 to provide protection against the virus in a mouse model.
As scientists and companies race to find vaccines to prevent COVID-19 infection, some platforms are focused on mRNA, others on viral vectors, viruses and various subunits. Vaxil is, to the best of the Company's knowledge, the only company working with signal peptides, which offer unique advantages of efficacy in stimulating a broad immune response while achieving a suitable safety profile. Vaxil's signal peptide platform has proven safety in a phase 1/2a study in oncology.
"The initial immunogenicity data sound intriguing," said Dr. Joseph W. Golden, a principal investigator in USAMRIID's virology division. "We look forward to evaluating this vaccine formulation for its potential to protect against SARS-CoV-2 in our mouse models."
The work to be performed by USAMRIID will be financed out of the Company's existing working capital, according to David Goren, Vaxil's Chairman and Chief Executive Officer. The team hopes to secure additional funding for future studies.
"We are pleased to have USAMRIID assess our potential COVID-19 vaccine," said Goren. "The work in the US will support and strengthen the experiments we have already done in Israel in our in-vivo study. Together, the combined research will help the Company plan and execute more efficient pre-clinical and clinical programs."
The Company is not making any express or implied claims that it has completed developing or will be successful in developing a COVID-19 (or SARS-CoV-2) vaccine at this time.
That is a tough call, like both of them. Check this out:
https://stocksregister.com/2020/10/30/astrotech-corporation-astc-is-sitting-on-a-potential-gold-mine/
"In predicting price targets of as low as $25 and as high as $25, analysts are in agreement on assigning the stock over the next 12 months average price target of $25."
Home > Boards > Canadian > Alternative Energy > Kontrol Energy Corp. (CNSX:KNR) (OTC:KNRLF)
SINT and ASTC are going to be good plays going forward in my opinion.
https://ih.advfn.com/stock-market/NASDAQ/astrotech-ASTC/stock-news/83497892/astrotech-subsidiary-and-cleveland-clinic-partner
https://sintx.com/
$SNANF possible approval tomorrow. Worst case this week. It seems HC has gotten all of their questions answered. Stock price likely to triple with approval and announcement of orders.
The company has hinted at tens of millions tests already ordered waiting for approval. 60M shares outstanding.
IFRX $5.05 COVID-19 ticket out of bottom area.... On watch for possible COVID PR....
$RLFTF (Covid-19) NeuroRx and Relief announce topline efficacy data from patients treated with RLF-100™ (aviptadil) under the U.S. FDA Expanded Access Protocol authorization for respiratory failure related to
https://relieftherapeutics.com/neurorx-and-relief-announce-topline-efficacy-data-from-patients-treated-with-rlf-100-aviptadil-under-the-u-s-fda-expanded-access-protocol-authorization-for-respiratory-failure-related-to/
TVOG - COVID play, 8K Released. Love this news that just came out.
Looks like a product that has a high demand and isn’t saturated. I’m going to order a few bottles and try it!
https://finance.yahoo.com/news/turner-venture-group-announces-completed-221000896.html
https://www.clinicaloncology.com/COVID-19/Article/10-20/How-Important-Are-T-cells-to-the-COVID-19-Immune-Response-/60839
22 million shares cash for 2 years insiders & tutes own 50% No debt
Partnership with Merck NIH for cancer & Infectious diseases MC Anderson Cancer Center & Farmacore (Brazil) Vaccine by end of 2021 in Brazil
http://www.pdsbiotech.com
https://www.pdsbiotech.com/images/pdf/presentation/2020/PDS_Biotech_Corporate_Presentation_-_OCTOBER_2020.pdf
PDS Biotechnology (PDSB) Virtual Road Show with CEO Frank Bedu-Addo, Ph.D. October 8th
$RLFTF Stanford University: Inhaled Aviptadil for the Treatment of Moderate and Severe COVID-19
Clinical Trial NCT04360096
Website
https://racetoacure.stanford.edu/clinical-trials/486
DD by tiggerifficm4
$RLFTF Good DD by Gemstone (post)
I highly recommend that everyone watch Dr. Javitt’s interview with Dr. Yo for themselves. I carefully listened to the interview, and heard several positive statements. In my opinion, Dr. Javitt’s disposition was the same as in his previous interview with Dr. Yo.
1) Dr. Javitt stated that in order to obtain an FDA EUA, the requirement is that the drug is safe and “MAY” be effective. He further explained that they ALREADY have evidence to meet these requirements for the FDA EUA, and referenced the clinical data available from the 21 patients treated with RLF-100 under the expanded access program. Thus, the data expected at the end of October from the ongoing clinical trial is NOT needed for FDA EUA, but will be used to meet the full FDA drug approval standard of “safe and effective”.
2) Israel has granted compassionate care protocol across the country for RLF-100.
3) The company has a cooperative agreement with NIH, where NIH is testing RLF-100 against the flu and other viruses (that kill people by attacking the lungs). If effective, there will be a broader use for the drug.
4) Doctors in Germany have used VIP in an inhaled form on a limited number of patients, and those patients are all back home.
5) Dr. Javitt reiterated the following information:
One of the most interesting things they’ve seen is that patients who have survived critical COVID-19 after being on ventilators, had twice the amount of VIP in their bloodstream than similar patients who died.
Dr. Javitt stated that VIP is how the lung recovers from all kinds of injuries. On an evolutionary basis, he views VIP as a perfect molecule.
SARS-CoV-2 binds to the ACE2 receptor on alveolar type 2 cells. The alveolar type 2 cells are critical to the function of the lungs. When the virus goes inside the alveolar type 2 cells, it shuts down the production of surfactant in the lungs. The surfactant keeps the lung coated and allows oxygen to pass across the lung. When you no longer produce surfactant, you cannot oxygenate your blood and that is the beginning of COVID-19 complications. If they can preserve the alveolar type 2 cells early in the disease, there is a chance they can make a significant impact on COVID-19.
Dr. Javitt interview
SNANF: looking like the last chance to get in SNANF before Health Canada approves their test for manufacture and sale in Canada. FDA and SFDA will soon follow. Then comes orders and NASDAQ listing. Lots of good things going to happen very quickly for Sona Nanotech. May be $100 per share by the end of the month.
$EPAZ News: Epazz, Inc. (OTC Pink: EPAZ) Increase in Covid-19 Sales will be seen on Q3 Financials https://ih.advfn.com/p.php?pid=nmona&article=83324425
RVVTF Is A Cheap CIVID-19 PlayInsider Financial
https://insiderfinancial.com/rvvtf-is-a-cheap-covid-19-play/180441/
$EPAZ News: Epazz, Inc. (OTC Pink: EPAZ) - Signs more Healthcare and Government Contracts- Covid-19 Solution https://ih.advfn.com/p.php?pid=nmona&article=83279537
$RLFTF NEWS - GENEVA, Switzerland and RADNOR, Pa. , Sept. 21, 2020 /PRNewswire/ -- RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) ("Relief" or the "Company") and NeuroRx, Inc.
- today announced the completion of their partnership agreement for the commercialization of RLF-100™(Aviptadil) worldwide.
The two organizations have agreed to share all profits from sales of RLF-100 for all indications related to COVID-19 and potentially other respiratory indications on a global basis.
They have agreed that NeuroRx will lead commercialization in the United States , Canada , and Israel , while Relief will lead commercialization in Europe and the rest of the world.
Profits from sales will be allocated to Relief and NeuroRx on a 50/50 basis in the U.S. , Canada and Israel , 85/15 (in favor of Relief) in Europe , and 80/20 (in favor of Relief) in all other territories.
The two companies have now taken steps to increase manufacturing of the aviptadil drug substance and are in the final stages of contracting with a fill/finish manufacturer, along with a national distribution partner. By January 2021 , Relief and NeuroRx expect to have manufacturing, distribution and logistics capacity in place to deliver sufficient drug quantities to treat 150,000 patients per month with RLF-100.
The companies continue to anticipate reporting top-line data from the ongoing randomized, double-blinded, placebo-controlled trial of intravenously-administered RLF-100 before the end of 2020.
The trial of inhalation-administered RLF-100 is slated to begin enrollment within the coming weeks.
As part of their agreement, Relief and NeuroRx intend to pursue the issuance of trademarks on RLF-100. NeuroRx shall prosecute such trademarks in the U.S. , Canada and Israel , while Relief shall prosecute trademarks in all other territories.
Raghuram (Ram) Selvaraju , Chairman of the Board of Relief , said: "We are pleased to reach this agreement with NeuroRx , a partner we believe is best suited to ensure rapid clinical development as well as timely and expedient interaction with regulatory authorities in what is likely to be the most important market for the drug, the United States .
We are looking forward to collaboratively and productively working together in order to maximize the value of the overall franchise for our shareholders and get this potentially life-saving drug to patients as swiftly as possible."
Jonathan C. Javitt , Chief Executive Officer of NeuroRx , added: "As the global pandemic continues to devastate families and communities, our small team is encouraged by the early promise we have seen in Sami Said's scientific legacy and we are working around the clock to bring this drug to patients."
Check out this video from Achiko:
IFRX $4.8 +10% InflaRx Announces Initiation of Phase III Part of Phase II/III Clinical Trial with IFX-1 in Severe COVID-19 Induced Pneumonia
First site initiated for enrollment in the Netherlands Regulatory approval granted to start trial in Germany Additional sites to be added in the US, EU and other regions Encouraging Phase II data accepted for publication in The Lancet Rheumatology JENA, Germany, Sept. 14, 2020 (GLOBE...
In case you are interested IFRX - InflaRx Announces Initiation of Phase III Part of Phase II/III Clinical Trial with IFX-1 in Severe COVID-19 Induced Pneumonia
Lexaria to battle COVID-19 with new patent.
$RLFTF Javitt Transcribed... CEO Roundtable with Dr. Javitt on Sept 10, 2020
by Uncle Gee Gee
-----------------------
I've transcribed the video and found many little nuggets of detail worth reading through.
For your weekend enjoyment...
CEO Roundtable with Dr. Javitt on Sept 10, 2020
15:55 Write - Jonathan, how does a clinical stage small molecule company that’s develop CNS-oriented therapeutics get involved in treating respiratory failure in Covid-19? I just want to understand how that happens.
16:20 Javitt - Well you know it’s like one of those extraordinary accidents, but some people say chance favors the prepared mind. And believe it or not vasoactive intestinal peptide, which is the active ingredient we’re working with, is a neuro endocrine peptide. And we were originally thinking about this in the CNS context. Then one of our investors came along and said well we have this company over in Switzerland that’s been thinking about this from a Covid-19 perspective. And sure enough it turns out that when Professor Sammy Said, who spent his whole life developing this peptide, really understood what it did, even though it was first identified in the intestine, which is why it has this funny name, 70% of the VIP in the body is in the lung, and it seems to have one critical function in the lung, which is to protect the Type II Alveolar Cells. Most people never heard of the Type II Alveolar Cell. In fact when I was in medical school, I don’t even think we knew that there were Type I and Type II cells. But this rare cell (there’s only about 5% of all the cells that line the lung), is the cell that is critical where the flow of oxygen’s coming in to the blood stream. And it makes the surfactant that lines the lung. Without the surfactant, the lung can’t transmit oxygen. And this funny virus, this virus that humanity’s never really encountered before SARS came along, attacks that one cell. It’s almost like hitting a needle in a haystack. And it attacks that one cell because that one cell happens to have ACE II receptors on its surface. So those funny spikes you see on the virus, they bind right to that receptor just like a key fitting a lock and the cell says come on inside, and as soon as the virus is inside the cell, it starts to make millions of copies of itself, it starts to let inflammatory cytokines loose all over the body, it ruptures the cell and it shuts down surfactant production, so all of a sudden, people who don’t even look that sick, have no oxygen in the blood. They can’t walk from their bed to the bathroom without falling down on the floor.
And… what we learned, what we expected is this would be a potent anti-cytokine. We thought we’d do a great job at blocking cytokines, and a great job at increasing surfactant production. And then lo and behold, a group of people we never heard of, at the Oswaldo Cruz Institute in Rio de Janeiro, reached out to us and said, you know that molecule you’re working with… here’s the data that shows that it blocks the replication of the SARS virus in human lung cells. So it was (inaudible 19:13) for us. It was, now we see why we’re seeing extraordinarily rapid recovery in the clinic. When we went into the clinic with this drug, and we literally went from paper files (because nobody has used this drug in humans for 10 years), from paper files to freshly formulated drug, with a fresh FDA certificate of analysis in human beings, in 10 weeks. When we went into the clinic, we expected to see an anti-inflammatory effect. We expected to see some of the same effects that Dr. Said saw in 2005 when he used this drug against Acute Respiratory Distress Syndrome, caused by sepsis, where seven out of eight people walked out of the ICU alive, when you would expect at least five of them to have died. What we didn’t expect to see, was chest x-rays clearing in 3 and 4 days. We didn’t expect to see that some of the early results we reported, where uh, you know out of the first 21 patients we treated outside our clinical trial, they were too sick to get into our clinical trial, 11 of those people have done very well, and 19 out of those 21 people have survived 28 days, which is the cutoff that NIH generally uses, 28-day survival is a critical endpoint. So we’ve been very surprised by the magnitude of response we’ve seen in the open label studies, and now we’re about a month away from the first unblinded look at the Phase III randomized control data. So, you know, we’re wondering, are we seeing the world’s biggest placebo effect, or are we really on to something.
21:15 Write - Rob Write asked a question regarding the company’s core competency and whether there was any internal struggle about pivoting on their strategy.
21:45 Javitt - I think the thing that is core to our company we’re just not afraid of anything. And we’re especially not afraid to go to FDA and say please help us break the rules. I mean there was 10 weeks from paper files to drug in the clinic in patients. Well that’s never going to happen through traditional GMP manufacturing, through standing up a fill and finish manufacturer. Those people take 6 months just to get their machines tuned up. So we went to FDA and said: You’ve got this list of 50 formulating pharmacies that you say passed your inspection. These 50 tiny little pharmacies that you say are safe, you didn’t shut them down, you actually certified them as formulating pharmacies, how about we make this drug in one of those formulating pharmacies?
We’re literally making this drug by hand in order to be able to get it into a Phase III trial overnight. And FDA was willing to help us break those rules, or at least willing to waive those rules, and recognize that if we’re facing the worst public health crisis in the last 100 years, we’ve got to be willing to do things in new ways, otherwise, we’re just dinosaurs looking at that asteroid coming closer and closer.
23:09 Write - I’m curious Jonathan about the formulating pharmacies idea. That’s kind of uh just an interesting approach, and I imagine your also trying to figure out how to do the scale up as you’re doing it now and it well in advance so things can continue to progress. Can you tell us a little bit about where the idea came about?
23:24 Javitt – Oh we’re hahaha we’re not going to try that one twice. So we’ve actually just signed a contract with one of those fill and finish manufacturers that we’re hoping to announce very shortly, uh and they’re actually the largest manufacturer of sterile inhaled drug in the world. Although our clinical trials with intravenous drug, we’ve already announced the trail that we intend to start quite shortly with an inhaled version of this drug, for people not with critical Covid-19, not the people who were on ventilators that we’re treating right now, but people with earlier stage disease in the hopes of keeping them from going on ventilators.
So we’ve started out the very non-traditional way, and we’re morphing as quickly as we possibly can to sort of rock-solid traditional scalability.
31:10 Write - Rob Write asks the panel about how to remain agile in an environment where FDA is getting political pressure to accelerate development, while also getting pressure from executives to base approvals on science, not political manipulation.
31:43 Javitt - Well I haven’t seen any evidence that FDA is being less stringent with people, they’re certainly not being less stringent with us. What they’re doing is being a lot quicker at being stringent. So, meeting requests that used to take 60 and 90 days, all of a sudden take, 60 and 90 hours to be answered. And when you send them a question, they’re turning around the answer in 48 hours. In 30 years of knowing the FDA, I’ve never seen anything like this. I’ve gotten emails from FDA scientists that they wrote and sent at two in the morning. So, it’s one thing to relax the standards, and it’s another to step up and apply those standards as quickly as you possibly can for the benefit of humanity.
32:42 Write - Rob Write continues the conversation about the FDA working long hard hours, despite typical hiring gaps.
33:23 Javitt - Well part of what’s changed things, and we really have Scott Gottlieb to thank for this, is the 21st Century Cures Act that was passed I guess it’s now, three and a half years ago, and then we have Scott come in as commissioner, being the first commissioner to really implement that act, and congress finally gave the commissioner of the FDA the tools that were needed to attract the best and the brightest, which included some real salaries. All of a sudden, FDA is able to pay salaries that certainly are not at the top of industry scale, they’re not paying anybody millions of dollars, but they’re able to pay somebody enough of a salary to leave a major pharmaceutical company, and take a job as a regulatory scientist to proving drugs, and without that, the agency can’t work.
36:57 Javitt - If you’ve got a, just a couple minutes, I’d love to go back to something Brian said earlier, when he said, you know, we’re focusing on the patients with most severe disease. And it’s certainly true that that’s where we started, uh because those are the patients who are dying by the hundreds and thousands, but, there really is a platform play that I think needs to be thought about by more people than just us. The whole story of this virus is its ability to enter very specific cells in the (upper thellia???). It only enters those weird cells that have ACE II surface receptors, and that’s mostly a couple of cells in the nasal zone, because that’s where the virus seems to get going, and then it goes down to the lung and it enters these Alveolar Type II Cells. And if you can stop that process, then the SARS Cov 2 virus is either asymptomatic or nothing more than a mild cold. And people are talking about, grand platforms and systemic approaches and all of that, but in fact, this virus is doing us so much harm, because its figured out how to hit a needle in a haystack, and the more we can focus on that needle, the more we can focus on how does the virus gets into that cell and how do we stop it in that cell. It may be that we never have a vaccine. I hope we do, but so far, as long as I’ve lived, we’ve never had a vaccine that’s able to stop an RNA virus. And yet similarly with pneumonia, we invented penicillin in the 1920’s, and it was 65 or 70 years before we had a vaccine against Pneumococcus, but we did a great job of keeping people from dying of pneumonia over those 70 years, just because we were able to interdict the process. So I truly hope we wind up with vaccines. I truly hope we wind up with sort of mobile immunologic approaches to this virus, but in fact there’s some very focused things we could be doing that we’re not doing to deal with this particular family of viruses and their determination to eradicate the human race.
50:16 Write - Rob Write asks for final parting thoughts.
50:20 Javitt - I think the most important thing is not to be afraid to break the rules. Yet the pharmaceutical industry is very tradition-bound. People know they’re supposed to do things a certain way, and that’s good, because by and large its kept the American pharmaceutical industry from having some of the crises that other pharmaceutical industries around the world haven’t had, but this is a time where we have to break the rules. I once watched a major pharmaceutical company lose $2 billion of revenue that their shareholders would have enjoyed having, because the person, and it was only one person, responsible for making clinical trial supplies, couldn’t figure out how to make clinical trials supplies for an existing drug, about a 15 year old drug, within 24 months in order to satisfy the FDA’s request for a pediatric trial that would have given them a 6 month patent extension, because you know, making boxes of clinical trial supplies for 150 people was just too much work. If we don’t break the rules, and if we don’t break the rules consciously every day, we’re going to lose many more people to this pandemic than we need to.
$RLFTF Here's the pre-print for the 19/21
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3665228
And the pre-print for the 6/6
https://www.preprints.org/manuscript/202008.0640/v1
And the Clinical Trials...
List: https://clinicaltrials.gov/ct2/results?term=Aviptadil&draw=2&rank=1#rowId0
• Clinical Trial NCT04311697 – The initial clinical trial underway to test intravenously administered drug. Approximately 86 out of 122 patients have been recruited as of Aug 12, and the company’s data committee will begin reviewing the cases once they reach 102 patients. From there, they will present findings to the FDA. Speculation: Review could begin this week of 8/24; however, official publication of results could take several more weeks, but likely before October, due to Javitt’s comments about being able to ramp up production by October.
• Clinical Trial NCT04453839 – The FDA-approved Expanded Access program for treating patients who are too sick for clinical trials.
• Expanded Access results were released in a “pre-print” document, showing 19 of 21 patients have survived. These are the sickest of the sick (ICU, ventilators, ECMO patients). The pre-print is under peer review & expected to be officially released in the coming weeks.
• Clinical Trial NCT04360096 – A study of 288 patients to test an inhaler-version of RLF-100, intended to ultimately be used for in-home treatments. Estimated completion of trial is November 30th. According to Dr. Javitt: “We expect that half the people we enroll in our inhaled study are going to be people who are outpatients.”
• Clinical Trial NCT04536350 – A study of 80 patients in Switzerland to test an inhaler-version of RLF-100 as a preventative treatment.
- Uncle Gee DD (copy)
DELL, INTC, ZM / Covid-19
https://emerginggrowth.com/dell-dell-and-intel-intc-backing-iabras-virolens-20-second-covid-19-test/
$QBIO Q BioMed featured in this Biopharma Update on the Novel Coronavirus: https://www.biospace.com/article/biopharma-update-on-the-novel-coronavirus-august-26/?TrackID=16
Q BioMEd, with its technology partner Mannin Research, announced a GMP production contract had been initiated for MAN-19, a clinical grade therapeutic to treat complications caused by COVID-19. The Phase I trial is expected to begin enrolling patients in February 2021.
SNANF. Likely in the next two weeks or less. FDA approval. Best Antigen test on the market once approved. Will be able to test asymptotic patients for more effective screening. During trials 33 out 33 asymptomatic patients properly identified. Lateral flow test similar to a pregnancy test will probably be the first test you can use at home.
SNANF, likely the last week to get in before FDA approval. Expecting at least 2-3 bagger on approval. Likely 5-10 bagger with sales announcement. Also waiting for Health Canada approval and Saudi FDA approval. All likely this month.
Hey...I started a new board about what it's like to have Corona Virus. If you have/had, or know someone who has/had CoronaVirus, please share your experiences:
https://investorshub.advfn.com/I-have-had-CoronaVirus-38361/
z
Cardiol Therap (CBD) Patent Applic Patients with COVID-19
https://www.cardiolrx.com/cardiol-therapeutics-files-international-patent-application-covering-the-use-of-cannabidiol-cbd-to-improve-the-outcome-of-patients-with-covid-19/
$HALB 0.007
Here we go!!!!!
https://www.accesswire.com/604004/Halberd-Selects-Arizona-State-University-ASU-to-Develop-Its-Patented-COVID-19-TreatmentsHalberd Selects Arizona State University (ASU) to Develop Its Patented COVID-19 Treatment(s)
Monday, August 31, 2020 8:00 AM
JACKSON CENTER, PA / ACCESSWIRE / August 31, 2020 / Halberd Corporation (OTC PINK:HALB) today announced the signing of a development agreement with Arizona State University (ASU) to conduct sponsored research to develop Halberd's Covid-19 treatments. The work will focus on developing antibodies in support of Halberd's two issued patents and three Covid-19 related provisional patent applications for extracorporeal removal of the virus' antigens from a patient's blood. It will also focus on neutralizing the effects of antigens and development of a potential therapeutic medication.
William A. Hartman, Chairman, President and CEO of Halberd Corporation stated, "ASU has demonstrated its expertise in biomedical research, including in the coronavirus arena through its recent development of the first Covid-19 saliva-based diagnostic test."
Good Day. What is next big Covid Play? In your Opinion
WAKEFIELD, MA – August 24, 2020 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, reports today receiving additional data from a U.S. Regional Biocontainment Laboratory (RBL) based on ongoing in vitro testing supporting Brilacidin as a potential treatment for SARS-CoV-2, the novel coronavirus responsible for COVID-19.
“The latest Brilacidin in vitro efficacy results against SARS-CoV-2 are outstanding,” noted Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “Selectivity Index is arguably the most important measure to compare the antiviral efficacy between experimental drugs and this new data suggests Brilacidin is in an elite group of anti-coronavirus candidates. For a point of reference, a SI greater than 100 is considered exceptional. Unlike thousands of other compounds and drugs under consideration as COVID-19 treatments, Brilacidin is demonstrating remarkably consistent and potent anti-SARS-CoV-2 activity in RBL testing, suggesting Brilacidin has tremendous potential as a COVID-19 treatment. We are actively planning to get Brilacidin into human testing as fast as possible, following necessary approvals and set-up procedures.”
In a new experiment at the RBL in a human lung epithelial cell line, Brilacidin, when directly incubated with the live (or wild type) virus, was shown to inhibit the virus by 50 percent (the IC50 value) at a mid-nanomolar concentration, while remaining non-cytotoxic to cells at high micromolar concentrations—establishing a SI for Brilacidin greater than 300 in this lung cell line. Additionally, this new testing in the human lung cell line showed Brilacidin’s IC90 value to be in the low micromolar range.
Based on public information (https://ghddi-ailab.github.io/Targeting2019-nCoV/preclinical/), a vast majority of other drugs being evaluated as COVID-19 treatments, including repurposed drugs, have SIs that are much lower than that achieved by Brilacidin. Moreover, according to a recent screening of 5,632 compounds (https://www.researchsquare.com/article/rs-23951/v1), including 3,488 compounds that have undergone clinical stage testing across 600 indications, only 19 compounds were identified as having an IC50 in the nanomolar (<1µM) range, as Brilacidin achieved, when tested against SARS-CoV-2.
Brilacidin has now exhibited robust in vitro anti-SARS-CoV-2 efficacy at low concentrations, well below already established clinically-achievable concentrations based on pharmacokinetics observed in the Company’s Phase 2b clinical trial of Brilacidin in Acute Bacterial Skin and Skin Structure Infections.
In other news, the Company is preparing to expedite planned clinical testing of Brilacidin for COVID-19, including identification of clinical trial sites. Interactions with the Food and Drug Administration, through its Coronavirus Treatment Acceleration Program, are anticipated to begin early September, along with the selection of a Contract Research Organization to implement the Brilacidin for COVID-19 clinical trial. Lastly, the manufacturing of Brilacidin intravenous (IV) drug product is expected to produce an amount in excess of what is estimated to be required for the Company’s planned Phase 2 clinical trial, allowing for extra IV drug product to support potential additional COVID-19 clinical testing.
Global COVID-19 Cases and Mortality
Pretty impressive on $RLFTF .........
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$RLFTF Uncle Gee Gee (CopyDD)
Summary of known facts about RLFTF: Aviptadil RLF-100 VIP
• Aviptadil is a repurposed erectile dysfunction drug, proven to be safe since 1970’s.
• Aviptadil blocks Covid from attaching to host cells in the lungs, prevents the cytokine storm, and reduces inflammation. This is a targeted trifecta for treating Covid.
• An inhaler version of Aviptadil will undergo clinical trials, with the intent to ultimately be used for in-home treatment of Covid cases. This study is expected to complete around Nov 31, with results being published sometime afterwards.
• Aviptadil is inexpensive and easy to manufacture.
• Aviptadil shows promise for other lung applications beyond Covid, which also needs to be studied and tested.
Stock/Company
• Relief Therapeutics holds the patent on Aviptadil. It is a small company in Switzerland, traded over the counter (OTC).
• NeuroRX is a private US-based partner with leadership that is well-connected at the highest levels of government and big pharma. They are guiding Relief Therapeutics through the FDA approval process.
• Company has $3M cash, but will need approx. another $20M to complete all 3 trials, including inhaler version.
• Unconfirmed: Most of the outstanding shares are owned by insiders.
• Chairman Raghuram (Ram) Selvaraju says there is no real need to raise capital via additional shares at this point, due to liquidity option provided by GEM.
• Speculation: Company may have recently raised enough additional capital to complete trials through Princeton Angels.
Manufacturing and Distribution
• Robert Bestoff, Chief of Operations, spent his career at Lilly & Pfizer. At Pfizer, he was head of entire neuro science and pain division and was responsible for $10b of drugs.
• Manufacturing program put together by Rich Siegel, former head of Johnson & Johnson’s drug portfolio.
• 2 Partnership arrangements are expected to be announced soon.
• “We are about to announce a partnership with the largest supplier of inhaled sterile drugs in the United States.” NeuroRX CEO Dr. Javitt
• “We are about to announce a partnership with a very large well-known public company that can get any drug to any hospital overnight” NeuroRX CEO Dr. Javitt
• “By October, we should be manufacturing enough drug for 100,000 people each month.” NeuroRX CEO Dr. Javitt
Clinical Trials
• Clinical Trial NCT04311697 – The initial clinical trial underway to test intravenously administered drug. Approximately 86 out of 122 patients have been recruited as of Aug 12, and the company’s data committee will begin reviewing the cases once they reach 102 patients. From there, they will present findings to the FDA. Speculation: Review could begin this week of 8/24; however, official publication of results could take several more weeks, but likely before October, due to Javitt’s comments about being able to ramp up production by October.
• Clinical Trial NCT04453839 – The FDA-approved Expanded Access program for treating patients who are too sick for clinical trials.
• Expanded Access results were released in a “pre-print” document, showing 19 of 21 patients have survived. These are the sickest of the sick (ICU, ventilators, ECMO patients). The pre-print is under peer review & expected to be officially released in the coming weeks.
• Clinical Trial NCT04360096 – A study of 288 patients to test an inhaler-version of RLF-100, intended to ultimately be used for in-home treatments. Estimated completion of trial is November 30th. According to Dr. Javitt: “We expect that half the people we enroll in our inhaled study are going to be people who are outpatients.”
#DDAmanda Chart (CLASSIC Insider Play) on: $RLFTF :
You can find these before they run:
What the Fact (Factor) Column is:
The Factor is a proprietary indicator used for scanning in #DDAmanda.
It's defined as Today's $Traded divided by the average daily $Traded (20 day avg).
SO, if a stock has say a 10 Factor that day, it means she traded 10 Times the $ she normally trades.
That's significant, and many times indicates that a run in the stock is coming.
$RLFTF Really good presentation .. Great 20 min. on Aviptadil and the 21 Patients.
Aviptadil (RLF-100) For COVID-19: 21 Patients With Severe Refractory COVID Showing Improvements!
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