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Start listening at 19:38.
Michael Frank on the Race to Fight Infectious Diseases | Revive Therapeutics (CSE:RVV)Sep 1, 2020
E-mail: mfrank@revivethera.com
At it's current Outstanding Shares count that would put the Company's MC around $69 billion.
Not realistic, imo. Sorry.
I don't know what their Authorized Shares count is. In the presentation it shows the Outstanding Shares count is 230,114,637.
Revive Therapeutics (RVVTF) Corporate Presentation October 2020
https://www.revivethera.com/wp-content/uploads/2020/10/RVV-Deck-v2-Oct2020.pdf
About the Phase 3 Clinical Trial
The Phase 3 confirmatory clinical trial titled, “A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients with Mild-Moderate COVID-19”, will enroll up to 1,000 patients that will be randomized 1:1:1 to receive Bucillamine 100 mg three times a day (“TID”), Bucillamine 200 mg TID or placebo TID for up to 14 days. The primary objective is to compare the frequency of hospitalization or death in patients with mild-moderate COVID-19 receiving Bucillamine therapy with those receiving placebo. The primary endpoint is the proportion of patients meeting a composite endpoint of hospitalization or death from the time of the first dose through Day 28 following randomization. Efficacy will be assessed by comparing clinical outcomes (death or hospitalization), disease severity using the 8-category NIAID COVID ordinal scale, supplemental oxygen use, and progression of COVID-19 between patients receiving standard-of-care plus Bucillamine (high dose and/or low dose) and patients receiving standard-of-care plus placebo. Safety will be assessed by reported pre-treatment adverse events and treatment-emergent adverse events (including serious adverse events and adverse events of special interest), laboratory values (hematology and serum chemistry), vital signs (heart rate, respiratory rate, and temperature), and peripheral oxygen saturation.
An interim analysis will be performed by an Independent Data and Safety Monitoring Board (“DSMB”) after 210 patients have been treated and followed up for 28 days after randomization. The better performing Bucillamine dose at the interim analysis will be selected and patients will then be randomized 2:1 to the selected Bucillamine dose or placebo. Additional interim analyses will be performed after 400, 600, and 800 patients have reached this same post-treatment timepoint. The independent DSMB will actively monitor interim data for the ongoing safety of patients and will recommend continuation, stopping or changes to the conduct of the study based on the interim analysis reports.
I emailed the Company 5 days ago specifically asking if they were still planning to expand the clinical trials to the Asia-Pacific countries and Canada. I haven't heard back, yet.
Thank you. I was able to find this one as well.
"Replying to @stock_cannabis and @Revive_RVV
I have been following them too. A few of my critical care anesthesiologist colleagues have told me it has some exciting potential."
10:57 AM · Oct 4, 2020
https://twitter.com/YoDoctorYo/status/1312784004970672134
Do you have a better link that shows Dr. Yo's actually reply about "I have been following them too"?
I have looked on both Dr. Yo's Twitter and The Cannabis Stock Twitter account and i can't find where Dr. Yo has made this reply.
Thanks.
The WH physician says Trump, as of this tweet, has been treated with the following:
— Remdesivir
— Regeneron REGN-COV2 antibody cocktail
— Zinc
— Vitamin D
— Pepcid
— Melatonin
— Aspirin
8:13 AM · Oct 3, 2020
The WH physician says Trump, as of this tweet, has been treated with the following:
— Steven Portnoy (@stevenportnoy) October 3, 2020
— Remdesivir
— Regeneron REGN-COV2 antibody cocktail
— Zinc
— Vitamin D
— Pepcid
— Melatonin
— Aspirin
This one is a gem, as well.
Berman - "We submitted the application late in the afternoon EDT, and incredibly we received our Pre-EUA Acknowledgement the morning of April 4, 2020, less than 24 hours later, and on the weekend. We were so stunned by the rapid acknowledgment that we waited almost two days to inquire whether the acknowledgment was what we have come to know as the “Pre-EUA.” We were assured that this letter from the FDA and the device serial number assigned are exactly what we had been hoping for.”
Someone refresh my memory. How many pre-orders of DECN’s Genviro Swift Kit Covid-19 blood test did their distributor, Universal Response LLC, claim to have received?
Was it about 1 million pre-orders? What ever became of that?
Is DECN's blood test even a ‘go’ anymore? (rhetorical question)
I've been going to the website daily for the past 4 weeks to check on any updates. Until today, the 'Recruitment Status' has always shown "Not yet recruiting".
It will be a different, additional study.
https://www.revivethera.com/2020/09/revive-therapeutics-announces-irb-approval-of-us-expanded-access-treatment-program-compassionate-use-for-bucillamine-in-covid-19/
Expanded Access Protocol (“EAP”) for compassionate use of Bucillamine.
"“The EAP serves as an option for patients that are not eligible for inclusion criteria in our Phase 3 clinical study in COVID-19 and the resulting data from the EAP will be valuable in supporting our clinical development of Bucillamine.”
"About the Expanded Access Study
The expanded access study is titled, “Multi-Center, Open-Label, Expanded Access Study of Bucillamine in Hospitalized Patients with Severe COVID-19 (EA-ARISE)”. Patients will receive Bucillamine 200 mg orally, 3 times a day (TID), for up to 14 days. The objective is to monitor the safety and efficacy of Bucillamine (600 mg/day) and any clinical symptoms when administered up to 14 days in hospitalized patients with severe COVID-19. Following completion of the treatment course, follow up safety assessments will be performed by a study nurse 14 and 42 days following the end of treatment."
For anyone that might be keeping score, i added 15,000 more shares today. Sitting at a total of 400,000.
Now, Revive Therapeutics (RVVTF) has my permission to announce the commencement of the Phase III trials. ;)
By the way, if you factor in all of the warrants being fully exercised then the OS will be close to 279,000,000.
It's from the company's August Corporate Presentation. It's shows as of August 28 the share price,(RVV) CSE ticker, of $.28 and the OS of 230,114,637.
15 of 17
https://secureservercdn.net/104.238.69.231/9v7.5b2.myftpupload.com/wp-content/uploads/2020/09/RVV-Deck-August-2020-ff.pdf
It would appear that Revive Therapeutics (RVVTF) is halted pending news. Does anyone want to wildly speculate as to why?
I'll start.(it's just for fun)
Perhaps RVVTF will announce an equity financing deal through a private placement or a grant? If so, maybe it was conditioned on the company first receiving FDA Phase 3 approval, IRB approval of the Phase 3 study, and IRB approval for compassionate use?
I'm already fully loaded but i added 15,000 more shares today. Expecting good things.
:thumbsup:
What ever happened to DECN's 13 million line of credit?
March 20, 2020
DECN to Finance 2Q 2020 Roll Out of its GenViro! Covid-19 “Rapid” Kits Using Non-Dilutive Debt Financing Totaling $13 Million Acquired in Near 0% Rate Environment
"The $13 million we seek, split by need, will carry us for the remainder of 2020."
https://apnews.com/ACCESSWIRE/026672c9f71fbb92a245aaaa08f269e4
I'm more curious to see Eli's side effects/safety profile data on their drug from their most recent study.
This is from June 2018. This is Eli's rheumatoid arthritis drug, sold under the brand name Olumiant.
FDA approves Olumiant for treatment of rheumatoid arthritis
"Olumiant is accompanied by a boxed warning about the risk of serious infections, malignancies, and thrombosis. Patients taking Olumiant also have experienced tuberculosis and opportunistic viral, fungal, and bacterial infections. These infections have led to hospitalization or death."
https://www.mdedge.com/rheumatology/article/167126/rheumatoid-arthritis/fda-approves-olumiant-treatment-rheumatoid
Revive Therapeutics' (RVVTF) Bucillamine is also an anti-inflammatory drug used to treat rheumatoid arthritis.
I view Eli Lilly’s news on it's drug as just more evidence that Bucillamine's repurposing for patients with mild to moderate COVID-19 symptoms could have great results.
The Company is looking to upgrade to the OTCQB, not the NASDAQ.
"Revive would also like to announce that it has commenced the process to have the Company’s common shares upgraded and quoted on the OTCQB® Market exchange in the United States. Commencement of trading through the facilities of the OTCQB® is subject to the fulfilment of the various regulatory requirements and completion of due diligence.
Moving to the OTCQB® in the United States will provide existing shareholders with an additional trading platform to the Canadian Securities Exchange in addition to introducing the Company to a broader range of retail and institutional investors that a U.S. listing provides"
https://revivethera.com/2020/08/revive-therapeutics-signs-mou-with-attwill-medical-solutions-for-phase-3-clinical-trial-for-bucillamine-in-covid-19-2/
September 10, 2020, 3:39 PM CDT
""The thing that's most perplexing to me as a physician is the extraordinary range and spectrum of disease severity," said Fauci. "About 80-plus percent of individuals have mild to moderate disease. About 15 to 20% have severe or critical disease. The case fatality rate varies greatly on age and underlying condition.""
https://www.yahoo.com/lifestyle/dr-fauci-just-said-youll-203948720.html
Off Topic:
09/08/2020
AstraZeneca Shares Plunge As COVID Vaccine Study Put On Hold Due To "Adverse Reaction"
https://www.zerohedge.com/medical/astrazeneca-shares-plunge-covid-vaccine-study-put-hold-due-adverse-reaction
Also:
09/08/2020
46-Year-Old Professor Collapses And Dies During Virtual Class After Succumbing To 'Long-Haul' COVID-19 Symptoms
"A history professor in Argentina who had been suffering from 'persistent coronavirus symptoms' for over a month collapsed and died while teaching a virtual lecture form her home."
https://www.zerohedge.com/medical/46-year-old-professor-collapses-and-dies-during-virtual-class-after-succumbing-long-haul
No general vaccination before mid-2021, according to WHO
September 4,2020
Geneva | The World Health Organization (WHO) said on Friday it would not expect a widespread vaccination against COVID-19 until mid-2021, as preparations for the distribution of a vaccine accelerate in the United States.
“As you know, a considerable number of applicants have now entered phase 3 of the trials. We know of at least 6 to 9 who have already come a long way in terms of research, ”WHO spokesperson Margaret Harris told a press briefing in Geneva.
“But in terms of a realistic schedule, we really don’t expect to see widespread vaccination until the middle of next year,” she added.
The spokesperson explained that sentence 3 of clinical trials – that is, the stage of massive testing on volunteers – is taking time, as scientists need to verify whether the vaccine is effective and safe.
Several pharmaceutical company executives for their part pledged Thursday to “cut corners” and to respect “safety” standards in the race for the vaccine against COVID-19, despite sometimes insistent calls to prefer it. the rapidity.
But “the good news is that manufacturers are already betting on which vaccine is likely to be, and are already thinking about how they can increase vaccine production once we know which one will be used.” Ms. Harris pointed out.
Competition rages on to develop a vaccine against COVID-19.
In the United States, the most bereaved country in the world, the Centers for Disease Prevention and Control (CDC) have “urgently” called on states to do what is necessary so that the distribution centers for a future vaccine can be ” fully operational by November 1, 2020 ”, just before the presidential election.
At the end of August, US President Donald Trump had also promised a vaccine “this year” against COVID-19.
In Geneva, Soumya Swaminathan, chief scientist at the WHO, told reporters this week that the organization has worked with experts from around the world, including the United States Medicines Agency (FDA) and the European Agency. drugs (EMA), to “propose criteria” for the safety and efficacy of future vaccines.
“We would like to see a vaccine with at least 50% efficacy, preferably better,” she said.
https://balthazarkorab.com/2020/09/04/covid19-no-general-vaccination-before-mid-2021-according-to-who/
The interview is now posted to Youtube.
Sep 1, 2020
Michael Frank on the Race to Fight Infectious Diseases | Revive Therapeutics
The other COVID stock (which i won't name) has a market cap of 1.3 billion with just a little over 2.5 billion outstanding shares.( That's a lot of shares, their PPS has a limited upside, imo)
Simply based on the other stock's market cap, i think initially a realistic target for RVVTF could be $4.50. And, i'm basing this target on a fully diluted outstanding shares.
RVVTF still has a tremendous upside from it's current PPS.
I'm not shitting but a $3,700 move (gain/loss) for every one cent move.
IMO, if the company was raising money they would do so through an Offering (Private Placement) like they've done before in the past. If so, they would need to disclose this. (Like they've done before)
Or, are suggesting that the company is raising money by selling shares on the open market, from time to time?
A wolf in whale's clothing.
From the article...
"Trump's decision to forge ahead is predicated by a study conducted by the Mayo Clinic and the National Institutes of Health which found that plasma treatments appeared to have a small but statistically significant impact on reducing mortality in hospitalized Covid-19 patients who received the infusions within three days of the onset of symptoms, compared with those who got plasma later.
Pouring cold water on Trump's major announcement, however, Statnews notes that the decision, which Trump’s press secretary heralded ahead of time as a “major therapeutic breakthrough," likely falls far short of that description, "and could generate intense controversy inside the administration and the broader scientific community."
Trump To Announce Covid Plasma Treatment Authorization At 5:30pm Press Conference
https://www.zerohedge.com/political/trump-jabs-fda-rejecting-hcq-claims-deep-state-or-whoever-delaying-vaccine-trials
Aug 15, 2020, 1:33 PM
"In a significant turn of events in COVID-19 testing, the U.S. Food and Drug Administration granted an emergency authorization for the public to begin employing a saliva-based test expected to significantly increase the availability, turnaround time and affordability of combating the coronavirus epidemic in the United States.
Developed by Yale University and jointly funded by the NBA and NBA Players Association, the testing method was granted approval by the FDA on Saturday.
The test — coined SalivaDirect — was developed to throttle up the screening process for a wide swath of Americans. The FDA approval marks a significant turn for testing in the U.S., creating the opportunity to make regular testing more readily available.
The retail pricing and companies that will carry the testing into the public domain are yet to be determined. The developers have revealed that testing could be done for as little as $4, although retail pricing is expected to be higher than that due to the cost of production, marketing, supply lines and retail outlet markups.
Fast test promised to be game-changer for sports
The test is expected to be a boon for the general public and professional sports as well. The testing of players and team employees would become an affordable and consistent occurrence, and it could help fans keep themselves safe before and after event attendance. Multiple NFL general managers told Yahoo Sports in early June that medical advisers told them a fast and affordable saliva test would be a game-changer for the league’s fall season.
“There we go,” one NFL general manager said on Saturday afternoon, reacting to the news. “I hope that ends up being the route the league goes!”
The peer review process has yet to take place on the SalivaDirect findings, but the data produced by Yale showed nearly identical results between groups of NBA players and staffers who were given both nasal swab testing and saliva testing. With the funding and backing of the NBA and the players union, that testing took place as the league began to ramp up preparations to finish its season in its Orlando bubble.
Fulfills country’s need for rapid, cheap, widespread testing
While other saliva tests for COVID-19 have been developed — and also received FDA approval — there have been complications with costs from $75 to $150 per test at the retail level. Turnaround times have also been as long as 48 hours. Those are two significant hurdles that the Yale research was hoping to dramatically change, aiming to make the test more affordable and the resting results more rapid. The driving theory behind that reach is that if more Americans can be tested faster and more affordably, the ability to respond to positive tests, while limiting exposure to others, will be dramatically increased.
The Yale test is also aimed at making the processing of tests more widespread in laboratories that meet the standards of an approval process developed by the university. Essentially, if any testing labs can show that they have the equipment to process the results safely, quickly and accurately, they can be considered for approval. That could rapidly expand the network of labs processing results, which could speed up turnaround times and also keep costs at a lower level.
While some professional sports teams are already using the pricier saliva testing methods and the NFL and NFL Players Association approved aggressive nasal swabbing protocols, all sports leagues that hope to host fans would be aided by faster testing methods in the population. Additionally, a fast saliva test could create the opportunity financially and structurally for the NFL and other leagues to have every employee orbiting their operations tested on a regular basis.
https://www.yahoo.com/sports/the-nba-and-yale-just-landed-the-covid-testing-breakthrough-the-nfl-and-everyone-else-in-the-us-has-been-hoping-for-183335566.html
What is stated...
"Error Repair
The company will endeavor to repair any and all errors that new sets of eyes find in this document after posting, whether these errors are in spelling, grammatical, punctuation related or numeric. We are not perfect and we remind others that the people who point our errors out to us, along with their public comments, are not perfect either."
4 of 24
"Further, the company plans to file a third EUA application for its GenViro! saliva based method, but this time will hold off on the application until the testing trials are complete and file the application along with the data."
https://backend.otcmarkets.com/otcapi/company/financial-report/254965/content
IMO, this application will never be filed because they will never complete any trials.
Speaking of the Russian vaccine.
Russia’s approval of a COVID-19 vaccine is less than meets the press release
"In a startling and confusing move, Russia claimed today it had approved the world’s first COVID-19 vaccine, as the nation’s Ministry of Health issued what’s called a registration certificate for a vaccine candidate that has been tested in just 76 people. The certificate allows the vaccine, developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Moscow, to be given to “a small number of citizens from vulnerable groups,” including medical staff and the elderly, a Ministry of Health spokesperson tells ScienceInsider. But the certificate stipulates that the vaccine cannot be used widely until 1 January 2021, presumably after larger clinical trials have been completed."
Click the link for the rest of the article.
https://www.sciencemag.org/news/2020/08/russia-s-approval-covid-19-vaccine-less-meets-press-release
IMHO, funding news for the trials.
TORONTO, June 09, 2020 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce that the Company met with Health Canada in a Pre-Clinical Trial Application (“Pre-CTA”) meeting to evaluate the potential of a clinical study of Bucillamine in the treatment of patients with mild-moderate COVID-19 due to the SARS-CoV-2 infection in Canada.
The Pre-CTA meeting provided an opportunity for Revive to discuss Bucillamine’s scientific rationale of its potential use in the treatment of COVID-19 infections, Chemistry, Manufacturing and Controls, non-clinical and clinical safety information, and clinical trial design. Health Canada provided valuable guidance on the proposed clinical study design and information required for the submission of a complete CTA package. The aim of the Company is to file its Investigational New Drug (“IND”) package to the U.S. Food and Drug Administration (“FDA”) for the proposed Phase 3 confirmatory clinical trial (“Phase 3 study”) this month and the Company also now intends to follow up with the submission of the complete CTA package for Health Canada around this Phase 3 study as part of the same multinational clinical strategy.
“We were pleased with our discussions with Health Canada at the pre-CTA meeting which provided us with valuable guidance on the clinical study design and information that is required for the submission of the complete CTA package,” said Michael Frank, Revive’s Chief Executive Officer. “We are focused on advancing Bucillamine as a potential treatment for COVID-19, and the submission of our FDA IND application for our Phase 3 clinical study will form the foundation for our multinational clinical plans including Canada."