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$NMXS News: Net Medical Begins Covid Testing on Behalf of New Mexico Department of Health
Leaning on two decades of experience connecting providers with the patients who need them, Net Medical's business is unique and growing.
ALBUQUERQUE, NM / ACCESSWIRE / February 7, 2022 / Net Medical Xpress Solutions (OTC PINK:NMXS) announced today it has begun Covid testing under an agreement with the State of New Mexico Department of Health.
Under the terms of the agreement, NMXS is:
Providing both rapid antigen and PCR tests at a variety of sites. Providing a licensed physician for Covid testing. Providing CLIA (Clinical Laboratory Improvement Amendments) certified laboratory facilities to process and analyze test specimens. Staffing and equipping a project management hub, laboratory, and mobile testing units with a capacity of 700 persons to be tested per day. Providing fully equipped mobile testing teams with a minimum of two persons per team for the region. Providing a copy of certified results from our CLIA certification to each person tested. Net Medical Chief Medical Officer (CMO) Dr. Neeraj Dubey, MD said, "We are delighted to be providing COVID testing services for the state of New Mexico. Our mobile testing vans are operating successfully in Albuquerque and Taos. This is an important activity for our company and, ultimately, for our shareholders as it is already contributing to increases in revenue and cash flow."
Net Medical is providing COVID-19 testing at Wilson Stadium in Albuquerque in cooperation with Albuquerque Public Schools and Sagebrush Inn and Suites in Taos as well as other locations.
For more information, call 505-255-1999. X 320. Visit www.netmedical.com. Email ir@netmedical.com
Net Medical partners with state departments of health, healthcare facilities, hospitals and clinics to provide extensive and unique customized solutions for the rapidly expanding multi-billion dollar telemedicine and testing industries. Understanding the complex and evolving needs of serving rural, regional, and high-risk populations, Net Medical has a long legacy of working with healthcare organizations to quickly create solutions that meet their immediate needs:
Providing access to care, keeping patients within hospital walls Providing complete care, anywhere - without the patient's need to travel Sustaining and growing revenue to continue viability in serving their communities About Net Medical Labs, Inc.
Net Medical's proprietary suite of services include Telemed platform, electronic medical records interoperability, state-of-the-art conferencing and communications, a call center, unique hardware implementations, and advanced research and development capabilities. No other telemedicine company offers the same extensive and integrated menu of telemedicine and laboratory services as Net Medical, allowing each healthcare organization the ability to custom-create an integrated solution that works for them.
$NMXS is providing vital testing for Covid-19 in New Mexico which is very much needed at this time. This company is making a significant contribution to combating the ongoing pandemic and saving lives.
From the company website:
Net Medical's unique suite of products and services addresses the unparalleled circumstances our global population faces due to the COVID-19 pandemic.?On-site Testing for your employees or event attendees provides an extra layer of safety at your location. Learn more about our mobile lab. Click here: https://www.welcome.netmedical.com/mobile-lab
Achiko CEO says Indonesian-launched COVID-19 Rapid Test "dramatically more accurate" than others.
In an interview with multi-media news platform Proactive, Achiko CEO Steven Goh shares the exciting progress of the Company's DNA aptamer-based COVID-19 rapid test AptameX™ in Indonesia and the plans to bring the test kit to other parts of Asia, the Middle East and northern Africa (MENA), and Europe.
COMMUSCISM was at 0% in the USA ww1, ww2, now we are at 50 %, the next plandemic in 10-12 years will destroy our country, if we dont act now to root them out.
$RLFTF $NRXP “Aviptadil has been granted compassionate care authorization in the United States and Israel and has been granted Emergency Use Authorization in Georgia, Ukraine, and the Caucasus region, as well as India.” INDIA Flag of India GEORGIA Flag of Georgia UKRAINE Flag of Ukraine EUA approved
ENZOLYTICS (ENZC) Close to a cure for Covid, Aids, and everything else. Uses Artificial Intelligence for its Monoclonal technology to learn how to defeat viruses by exposing then attacking the weak spot of the virus. Has a White Paper with Intel and may be partnering with Pharma distributor Lonza. They are working at Texas A&M university and a few other places.
ENZOLYTICS (ENZC) Close to a cure for Covid, Aids, and everything else. Uses Artificial Intelligence for its Monoclonal technology to learn how to defeat viruses by exposing then attacking the weak spot of the virus. Has a White Paper with Intel and may be partnering with Pharma distributor Lonza. They are working at Texas A&M university and a few other places.
$IBIO iBio, Inc.“Studies of convalescent sera from patients that have recovered from SARS-CoV-2 infection have shown that the combination of N-directed and S-directed immunity is important,” said Martin Brenner, DVM. Ph.D., iBio’s CSO. “Accordingly, we believe the N protein strategy of IBIO-202 may be complementary with existing S-directed vaccines, conferring additional protective effects that more closely mimic the natural immune responses of patients that have cleared the virus.”
$IBIO iBio, Inc."Data on commercially available COVID-19 vaccines - all of which target the spike protein (“S protein”) - suggests that neutralizing titers are effective, but likely to wane over time. In addition, the robustness of T-cell priming and cellular immunity achieved by S protein-directed vaccines may not be sufficient to create a durable immune response, especially in the context of emerging variant strains of the virus. In contrast, the N protein gene is more conserved and stable than the spike, with 90% amino acid homology and fewer mutations over time. Notably, the SARS-CoV-2 N protein shares substantial sequence conservation with the nucleocapsid of other coronaviruses."
$MJNA First to Address the United Nations About CBD In November of 2017, Medical Marijuana, Inc. subsidiary HempMeds® Mexico became the first company to address the United Nations and the World Health Organization (W.H.O.) about cannabidiol (CBD). HempMeds® Mexico President Raul Elizalde was invited to Geneva to speak at the W.H.O Meeting of the Expert Committee on Drug Scheduling, where he urged the committee to recognize CBD as non-psychoactive and to classify it as a nutritional supplement.
$IBIO iBio on May 6 disclosed the development of IBIO-202. “In light of the successful global roll-out of COVID-19 vaccines targeting the S protein and the emergence of variant strains of the disease, we decided to focus our efforts on the continued development of IBIO-202 as a differentiated vaccine candidate,” stated Tom Isett, iBio’s chairman and CEO. https://www.genengnews.com/covid-19-candidates/ibio-ibio-202/
$IBIO “Immunization with more conserved sequences, such as the N protein, is expected to generate T-cells that could clear spike protein variant viruses in addition to the original virus,” said Martin Brenner, DVM. Ph.D., iBio’s CSO. “The N protein strategy of IBIO-202 is complementary to existing first-generation, S protein-directed vaccines and may be suitable as a more universal coronavirus vaccine.”
$IBIO Using its plant-based FastPharming® System, iBio has successfully expressed N protein antigens and has initiated both intramuscular and intranasal preclinical studies to identify favorable antigen-adjuvant combinations. Results are expected in early Q1 FY2022. iBio recently filed four provisional patent applications with the U.S. Patent and Trademark Office in support of the IBIO-202 program.
$IBIO The Company recently reported on development of IBIO-202, a subunit vaccine candidate that targets the nucleocapsid protein (“N protein”) of SARS-CoV-2. N proteins of many coronaviruses are highly immunogenic and are expressed abundantly during infection. In addition, the N protein is more highly conserved than the S protein, and therefore new viral variants may be less likely to escape vaccine protection.
"In light of the successful global roll-out of COVID-19 vaccines targeting the S protein and the emergence of variant strains of the disease, we decided to focus our efforts on the continued development of IBIO-202 as a differentiated vaccine candidate,” commented Mr. Isett. “The COVID-19 vaccine space remains highly competitive, with multiple approved vaccines in use in many countries. Nevertheless, various unmet needs remain, including: vaccines that provide broader protection against variants; the potential requirement for annual vaccine boosters; vaccines that do not require significant cold chain management; vaccines with alternative routes of administration; pan-coronavirus vaccines; and wider vaccine availability in developing countries," said Mr. Isett.
LHDX just IPO'ed yesterday and they have their EUA from the FDA. They make at home covid test kits.
With the implementation of the Defense Production Act, this company should benefit, especially since the government is seeking 6 at-home covid test suppliers.
"Manning said the federal government is also using the DPA to increase the supply of at-home, rapid COVID-19 tests by bringing on six new suppliers that’ll be able to deliver 61 million tests by the end of the summer."
CYDY Covid play-courtsey of youssef: CytoDyn has one of the sexiest stories on the street. Friday, after the bell the company announced the initiation of sales in the Philippines. For years the shorts have been clamoring about no revenue and it looks like CytoDyn’s CEO finally took away their favorite piece of candy. This was only one part of the news, the other part was the shocking announcement that 100,000 doses of the drug was to be reserved for the Philippines and their partner Chiral Pharma Corp. The Manilla Times picked up on the story. There are currently only 250,000 doses ready to be shipped out of Samsung South Korea. This news puts the United States FDA in a pressure situation to approve the drug. In a webinar last week some of the country’s top doctors and regulators in the Philippines were educated on the Compassionate Special Permit (CSP) for leronlimab. CytoDyn also hinted that this was a stepping stone to an EUA and ultimately an approval in the philippines. The idea is that these compassionate use patients would fit the CD12 enrollment criteria for the extension trial and help get more data on the drug. The CEO Nader Pourhassen said
$SBFM: Sunshine Biopharma Receives Fourth Tranche From Previously Announced $2,000,000 + Financing for Coronavirus Treatment
MONTREAL, QC / ACCESSWIRE / January 14, 2021 / 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 has received the fourth tranche of funding under the recently announced committed minimum financing of $2,000,000 with RB Capital Partners Inc. This brings the total to $1,050,000 that the Company has received to date under this financing. The proceeds will be used for the ongoing development of the Company's Coronavirus Treatment on a priority basis and the clinical development of Adva-27a, the Company's flagship anticancer compound targeted for pancreatic cancer.
Sunshine Biopharma Inc. CFO, Camille Sebaaly stated, "As a company, we continue to forge forward in our development of a COVID treatment and our anticancer compounds. This investment capital has been integral to our progress in each of these sectors."
Brett Rosen and Deborah Braun of RB Capital Partners Inc. stated, "We are very impressed with the Sunshine leadership team and their commitment to developing critical life-saving medical treatments. Our investment money has been met with ongoing milestones and we are pleased to be considered a long-term funding partner of the Company. We are looking forward to a potential up-list to the Nasdaq in the future."
About Sunshine Biopharma's Coronavirus Treatment Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) is the causative agent of the ongoing COVID-19 pandemic that has claimed the lives of over 1.9 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 several molecules which were designed by computer-aided modeling to inhibit the Coronavirus proteases, thus shutting down the ability of the virus to multiply. Sunshine Biopharma has since completed the synthesis of four such molecules and identified a lead compound, SBFM-PL4. In collaboration with the University of Georgia, College of Pharmacy, the Company is currently advancing the development of SBFM-PL4 through the in vitro testing stage to be followed by mice studies before entering clinical trials on COVID-19 patients.
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 Contact: Camille Sebaaly, CFO Sunshine Biopharma Inc. Direct Line: 514-814-0464 camille.sebaaly@sunshinebiopharma.com http://www.sunshinebiopharma.com
What’s everyone thoughts on APT. I’ve been watching them for a few months now and they are a PPE Manufacturer. They will be reporting next month and based on previous reporting they have done well. Also with potential new mask mandates and spiking cases could they be a good play?
$RLFTF (related) We are pleased to announce the inclusion of ZYESAMI™ (RLF-100™: aviptadil) in the I-SPY COVID-19 Trial which will allow us to gather data on the use of inhaled aviptadil for Critical #COVID19.
We are pleased to announce the inclusion of ZYESAMI™ (RLF-100™: aviptadil) in the I-SPY COVID-19 Trial which will allow us to gather data on the use of inhaled aviptadil for Critical #COVID19.
GATEKEEPER REPORTS $20.3M REVENUE, $3.5M NET INCOME, $0.04 EPS IN RECORD BREAKING FISCAL 2020
61% CAGR revenue growth in two years
Abbotsford, BC – December 10, 2020 – Gatekeeper Systems Inc. (‘Gatekeeper’ or the ‘Company’) (TSX-V: GSI) (OTC: GKPRF) (FSE: 1GK) a video and data solutions provider for public transportation and smart cities, reports audited financial results for fiscal year ended August 31, 2020.
Fourth Quarter and Year-End Highlights
Revenue for the year ended August 31, 2020 was $20,316,576, the highest fiscal year revenue in the Company’s history and an increase of 48% when compared to $13,726,313 for the same period in the previous year;
Revenue for the fourth quarter was $7,732,074 ($30,928,000 annualized), the highest fourth-quarter revenue in the Company’s history and an increase of 58% when compared to $4,879,510 in the same period in the previous year;
Gross profit for the year ended August 31, 2020 was $8,348,810, the highest gross profit in the Company’s history and an increase of 37% when compared to $6,104,128 for the same period in the previous year;
Net income for the year ended August 31, 2020 was $3,535,007, the highest net income in the Company’s history and an increase of 1337% when compared to net loss of $285,827 for the same period in the previous year, and representing 17.4% of revenue;
Working capital as at August 31, 2020 was $8,325,049. The Company had immaterial long term debt and approximately 89.4 million shares outstanding;
Introduced Platform-as-a-Service (PaaS) business model as an enabling transformation to a video and data solutions provider for intelligent transit and Smart Cities; Announced several customer contracts for video analytics software solutions; Launched Intelligent Temperature Sensing Systems (ITSS) for passenger health monitoring on school buses and transit buses; Completed design and delivery of NTSB compliant digital video recorders in a $6.3 million contract for the sixth largest transit authority in the US; Commenced annually recurring contract to provide video services for the sixth largest transit authority in the US valued at approximately $12 million over 5 years and was deemed essential business during the COVID-19 pandemic; and
Entered a non-dilutive revolving credit facility with TD Bank for up to $3 million.
Management Commentary
Doug Dyment, President and CEO commented: “I’m extremely pleased with the fantastic results that our team delivered during a fiscal year which was overshadowed by a global pandemic and economic uncertainty. We adjusted our operations quickly and efficiently to protect our employees, allowing our business to operate as an essential service. We continued to develop our new AI-based platform for Smart Cities and developed new solutions to improve passenger safety and transit efficiency as cities reopen following COVID-19 lockdowns."
"Our new passenger health monitoring panel became part of our PaaS platform and its facial recognition feature paves the road for future applications like contact tracing, passenger counting or payment verification, and strengthens our transformation to a video and data solutions provider for Smart Cities.”
Several new initiatives were established during the 2020 fiscal year which the Company expects will contribute strongly to future growth. They include:
Platform-as-a-Service (“PaaS”) Business Model – during the year, Gatekeeper introduced the PaaS business model as an enabling transformation to a video and data solutions provider for intelligent transit and Smart Cities. Over the past seven years the Company has installed over 28,000 intelligent mobile data collectors and 97,000 video devices on school buses, transit buses and trains for over 3,500 public transportation customers.
These intelligent devices form the foundation of the Company’s PaaS business model by collecting vehicle data such as video, audio, GPS, time, door open/close and serve as the “black box” to aid in transit accident investigations. The PaaS units are WiFi enabled, mobile connected, or mobile enabled, allowing public transport assets to become part of an intelligent transportation solution in a Smart City ecosystem. The PaaS platform also serves as the AI-based intelligence platform for future applications such as thermal camera sensors, passenger counting, contact tracing, intelligent routing, license plate capture, video evidence and more.
Artificial Intelligence and Video Analytics Software – during the year, Gatekeeper continued development of video-based artificial intelligence offerings. AI offers the potential to evolve conventional video into machine-vision intelligence to automatically record, alarm, enforce, or take action without human interaction in applications such as abnormal driver behavior, abnormal passenger behavior, passenger counting, or license plate capture and ticketing of vehicles illegally driving in the bus lane or passing streetcars or school buses while passengers are loading or unloading.
Many customers choose Gatekeeper because of its video analytics software which allows easy zooming, facial blurring and enables quick and easy assembly of video evidence needed to deal with problems such as bullying, grazing or verbal abuse on school buses.
Passenger Health Check Initiative – during the year, Gatekeeper launched Intelligent Temperature Sensing System (ITSS) as its first health check offering. ITSS is a contactless infrared body temperature sensor system that incorporates a smart panel, thermal imaging, and artificial intelligence to measure body temperature within 20 milliseconds. The panel is equipped with facial recognition capabilities to improve accuracy and allows authorities to prepare future applications such as intelligent passenger routing, contact tracing, passenger counting, or payment verification.
The Company believes passenger health monitoring in public transportation is an emerging growth trend that will continue even after the COVID-19 pandemic subsides. An estimated 25 million schoolchildren and 18 million transit passengers board buses daily in the US alone, mostly at locations that are not stations which necessitates on-bus installations for passenger health screening devices. The Company is integrating ITSS into its PaaS platform business model as a new additional data layer.
NTSB Compliant Digital Video Recorders – during the year, Gatekeeper completed the design and supply of digital video recorders (DVRs) and crash hardened memory modules (CHMMs) that record and protect operating evidence in rail transit applications. The DVRs and CHMMs have continuous-recording capabilities that can be used to verify crew actions and train operating conditions, which greatly aids accident investigations in the same way black boxes are used in the airline industry.
They are compliant with the recommendation made by the National Transportation Safety Board (NTSB), which calls upon the Federal Transit Administration to install crash-resistant inward and outward-facing cameras and continuous recorders in all rail transit vehicles. The Company completed its first installation, equipping the trains of the sixth largest transit authority in the US through a $6.3 million contract.
Annually Recurring Video Services – during the year, Gatekeeper was awarded a contract to provide annually recurring vehicle video system maintenance services to Southeastern Pennsylvania Transit Authority (SEPTA), the sixth largest transit authority in the US. The contract is valued at approximately $2.36 million per year and SEPTA has approved an initial three-year service term plus two one-year extension options for a total potential contract value of up to $11.8 million over five years. SEPTA is actively using video evidence as protection against fraudulent claims and has installed more than 27,000 video cameras on vehicles and in stations. Gatekeeper was deemed an essential business during the COVID-19 emergency order which temporarily prohibited operations of non-essential businesses in Pennsylvania.
Selected Financial Information
The following sets out selected financial information from the Company’s four most recently completed financial years and are derived from the Company’s consolidated financial statements. Users of this information should read the following in conjunction with those statements thereto.
Full details of the financial reports and operating results for the year ended August 31, 2020 are described in the Company’s consolidated financial statements with accompanying notes and related Management’s Discussion and Analysis, available on SEDAR at www.sedar.com.
About Gatekeeper Systems Inc.
Gatekeeper is a leading provider of intelligent video and data solutions designed to provide a safer transportation environment for children, passengers, and public safety personnel on multiple transportation modes. The Company uses AI, video analytics, thermal cameras, and mobile data collectors to inter-connect public transit assets as part of intelligent transportation systems in a Smart City ecosystem. The Company’s Platform-as-a-Service (PaaS) business model is an enabling transformation to a video and data solutions provider for intelligent transit and Smart Cities.
GATEKEEPER OFFERS RAPID TEMPERATURE CHECKS FOR SPORTS VENUES, SIGNS VANCOUVER GOLF TOUR IN RECURRING REVENUE MODEL
Abbotsford, BC December 14, 2020 Gatekeeper Systems Inc.
(‘Gatekeeper’ or the ‘Company’) (TSX-V: GSI) (OTC: GKPRF) (FSE: 1GK) a video and data solutions provider for public transportation and smart cities, will deploy its Intelligent Temperature Sensing Systems (ITSS) in a solution designed for rapid testing at sports venues. The Company has signed the Vancouver Golf Tour (“VGT”) as its first sports venue customer, in a recurring revenue business model.
“For the past 14 years, VGT has been providing thousands of golfers in our region with an opportunity to compete in professionally-staged tournaments,” stated VGT Commissioner Fraser Mulholland. “We have always prided ourselves on the professional nature of our events and providing a year-long tournament platform for our local players to put their skills to the test in a PGA Tour-like environment”.
“One of the cornerstones of the Vancouver Golf Tour from day one has been to ensure our player’s safety. With the onset of the COVID-19 pandemic, VGT was quick to adopt an extensive list of COVID-19 safety protocols at our events so our players could continue to aspire to greatness, safely through our tour."
"With the introduction of Gatekeeper’s ITTS solution at our events for 2021, VGT is adding yet another layer of safety for our players and our operations team so we can continue to provide players in our region with the professional tournament experience they need to move onto the next level,” added Mulholland.
Doug Dyment, President and CEO of Gatekeeper commented: “For the past few months all of our employees have been conducting ITSS temperature checks before entering our manufacturing facility, and we have learned how ITSS can be effectively utilized in multiple market applications for both fixed and portable locations, especially where automated rapid temperature testing is required – such as sports venues. We are pleased to be working with the VGT as our first customer in this new application.”
ITSS is a contactless infrared body temperature sensor system that incorporates a smart panel, thermal imaging, and artificial intelligence to measure body temperature within 20 milliseconds. The panel is equipped with facial recognition capabilities to improve accuracy and allows customers to accommodate future applications such as automated contact tracing and membership verification.
The Company believes that public health monitoring is an emerging growth trend that will continue even after the COVID-19 pandemic subsides. It recently commenced a national marketing campaign designed to reach over 50,000 influencers and decision-makers to raise awareness of how ITSS can help organizations with health monitoring and contact tracing.
About Vancouver Golf Tour
The Vancouver Golf Tour (VGT) was developed in 2006 for BC’s local Professionals and Amateurs (Handicap of 0-18) – giving them the opportunity for a high level of competition in a PGA Tour environment without the heavy expenses of travel. VGT’s goal has always been to provide local players the opportunity to learn how to win while at the same time building their confidence to play on Worldwide Major Tours. For more info, visit www.vancouvergolftour.com.
About Gatekeeper Systems Inc.
Gatekeeper is a leading provider of intelligent video and data solutions designed to provide a safer transportation environment for children, passengers, and public safety personnel on multiple transportation modes. The Company uses AI, video analytics, thermal cameras, and mobile data collectors to inter-connect public transit assets as part of intelligent transportation systems in a Smart City ecosystem. The Company’s Platform-as-a-Service (PaaS) business model is an enabling transformation to a video and data solutions provider for intelligent transit and Smart Cities.
I have a sleeper to share; and it's only a matter of time before it blows up. It has a low float and they recently got their EUA from the FDA; they got their CE mark in October, and they were peer reviewed in the Science Journal.
RNLX
RNLX, in partnership with Kantaro Biosciences has the first and only digital readout Covid tests for antibodies. Their test goes beyond a simple "positive", "negative" result but gives accurate numbers. Read more for yourself. Good luck.
$RLFTF (related) copy by frenchman yhoobrd - Many of us here have been lambasting the FDA for their delay tactics- word is starting to spread:
“FDA regulators are wasting precious time in greenlighting a COVID vaccine as more than 2,000 Americans are dying each day and the pandemic continues to starve American society.
Pfizer submitted data detailing the safety and effectiveness of its vaccine on Nov. 22. But rather than immediately convening experts, the FDA scheduled a review meeting on Dec. 10, almost three weeks later. As Pfizer’s application sits on the shelf at the FDA awaiting authorization, about 27,000 Americans will have died. So what is the FDA doing for three weeks?
As a Johns Hopkins scientist who has conducted more than 100 clinical studies and reviewed thousands more from the scientific community at large, I can assure you that the agency’s review can be done within 24 to 48 hours without cutting any corners. They just need to work harder.
Contrary to popular belief, the FDA process is not hands-on—it does not interview vaccine trial patients or look under a microscope at the immune cells. It’s doing a statistical analysis and looking at data. For the vaccine trial, the data set is small and straightforward. If my research team, normally tasked with analyzing data on millions of patients, was asked to review the smaller Pfizer vaccine study of 43,000 patients, it would take about one hour.
The FDA also reviews manufacturing data from Pfizer on how they made the drug. But not only can that data be reviewed in a few hours, it should have been done months ago when it was available. While the FDA was waiting for Pfizer’s long-term vaccine results to come in, the agency should have anticipated this step and done it early.
The final step of the FDA review is to look at the outcomes of the study volunteers, including rates and severity of infection and side effects in the vaccine and placebo groups. Again, there is no plausible reason why this basic analysis cannot be done in 24 hours. The FDA and external scientists have a simple task: confirm or reject the review already conducted by the trial’s independent data safety monitoring board before FDA submission.
Let me be clear: The agency should not cut any corners in its review process, just cut out the sitting-around time. FDA insiders say the agency and its approximately 17,000 employees were dark for the four-day Thanksgiving holiday, including those working on the vaccine approval. It’s time the FDA adopts a sense of urgency. We’ve had Operation Warp Speed in developing vaccines but Operation Turtle Speed in reviewing the results...”
m @Bridge for future reference I would just have someone focus on the most efficacious of the two which is RLF-100, right? I don’t known if leronlimab is putting out numbers that are overall better than Aviptadil.
Bridge I tweeted to Dr. Makary, responding to an earlier tweet of his. I know it’s probably useless, and after all what could he do? But I find myself sending out a tweet every few days to someone who may be able to raise these concerns. Maybe better than just watching this nightmarish delay, which makes so little sense.
Read your article re FDA vaccine delay. Same with COVID TREATMENTS like #Leronlimab and #Aviptadil - In trials since April/May - MOA against COVID is known - Qualify for EUA: are SAFE and without doubt “may be” effective - FDA is taking so long while so many die - Can you help?
m Dr. Marty should have focused on RLF-100 and it’s slow progress because it has a known safety profile whereas vaccines are not as well known. Pushing out RLF-100 in the 10’s of millions this December would have done more than the vaccines will. I could be wrong but would love to learn why.
Bridge Thanks for posting. What an indictment! And that’s just the vaccines. We all knew it didn’t make sense that viable treatments like RLF-100 and leronlimab are still sitting on the shelf.
What the hell is going on? I don’t think it can be corruption like big pharma money. No half-way normal person would allow tens of thousands of deaths for money. It must be some combination of things like human complacency and stupidity. It’s hard to witness this nightmare.
crymeariver They should focus on saving dying people instead of vaccinating healthy people.
frenchman @BigGator There doesn’t seem to be a sense of urgency - the question is why?
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