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EUA for Royaldee
Thx Emily! Surprised no media abt EUA expected Feb for Rayaldee - FDA fast-tracked trial already and has proved to vitD levels to 50ng w/in 48 hours, faster than any alternative w/ safety equiv to placebo? https://t.co/vXB1OMgF1O Esp aft https://t.co/AV2pPtbAE6 @CristinaDragani
— Sian Capital (@sian_capital) January 8, 2021
Day two of COVID-19 testing for Bills fans
https://www.wivb.com/sports/buffalo-bills/day-two-of-covid-19-testing-for-bills-fans/
BioReference's Ryan Kellogg highlights day one of testing at Bills Stadium https://www.radio.com/wben/podcasts/wben-extras-20618/bioreferences-ryan-kellogg-highlights-day-one-of-testing-at-bills-stadium-353970167
They will surely provide updates on Orladeyo sales next week!
Breaking out!!!!
My theory is that the holders of the convertible notes are going to push the PPS over $5.48 this quarter to get an early conversion. They cannot wait for the next quarter. OPK will soon have the cash to pay the notes off by cash!
What happened to the PMA submission for 4K score?
OPKO Plans to Refile 4Kscore De Novo Submission as PreMarket Approval Application (PMA): The Company plans to refile its 4Kscore® test submission as a PMA application based on FDA feedback to the Company’s de novo request for this test, which has now been withdrawn. The FDA did not request any additional clinical data or any additional clinical trials in connection with a PMA submission. The Company currently anticipates submitting the PMA application in August 2019.
What is clear however is that optimisation of defensive immunity is now more important, as this is expected to protect us against all mutations of Covid-19. The need for correction of vitamin D deficiency is greater than ever.
A breakout to $5 level is coming!!
High dose vitamin D improves total serum antioxidant capacity and ICU outcome in critically ill patients - a randomized, double-blind clinical trial
https://www.sciencedirect.com/science/article/pii/S1876382020314529
The shorts game became how to cover rather than when to cover. Not all of the shorts are hedged.
The MAG people are waiting on that. LOL
LOL. My wife just told me someone did research on how stocks performed once their CEOs died. Most of them went UP!!!
Vitamin D as a preventative measure
Early on in the UK pandemic it was clear that Black African & Asian NHS Doctors were highly susceptible to Covid-19. This was evident from tragic news reports of front-line doctors dying of Covid-19 that all seemed to be Asian. In the first month of lockdown 25 front-line doctors died of which 24 were of Black African or Asian ethnicity. You might be wondering why you are not still hearing of the awful slaughter continuing. Well, the British Association of Physicians of Indian Origin wrote out to their members on 29 April advising them to take Vitamin D.
https://www.bapio.co.uk/vitamin-d-recommendations-for-bme-staff/
They also organised the distribution of vials of fast-acting Vitamin D (Calcifediol) to medics. The drop-off in deaths is nothing short of miraculous.
https://www.stockopedia.com/content/why-arent-front-line-asian-doctors-still-dying-of-covid-19-bioventix-bvxp-the-prospect-of-routine-vitamin-d-testing-734994/
With Soma PDUFA date insight, the game is changed now!
Does anyone know the date when the ceiling for REG CF will be raised?
shares are locking up!
That really sucks
Very likely mRNA vaccine will do nothing to the new variant strains, spike proteins N501Y and P681H
Amazon no longer in health care business https://www.cnbc.com/2021/01/04/haven-the-amazon-berkshire-jpmorgan-venture-to-disrupt-healthcare-is-disbanding-after-3-years.html
We are well funded by Covid testing until PDUFA in October!
Lots of good things happening with OPK. I believe Frost has his plan, just not the one Sian shuffled to him.
Back to back PR. The margin for the PCR tests should be increasing by time
LOL 2021
OPKO Health's BioReference Laboratories Reports Results of the Largest COVID-19 Public School Testing Program Nationwide
Download as PDFJanuary 04, 2021
Nearly 210,000 New York City students, teachers, principals and staff were tested by BioReference with a positivity rate of 0.47%
ELMWOOD PARK, N.J., Jan. 4, 2021 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ: OPK), today announced the results of COVID-19 molecular PCR tests for public schools throughout New York City's boroughs, with a positivity rate of 0.47 percent.
BioReference Laboratories, Inc., an OPKO Health Company. (PRNewsfoto/BioReference Laboratories, Inc)
BioReference announced the COVID-19 PCR test results for NYC's public schools, with a positivity rate of 0.47.
"These results indicate that an active surveillance system can be successfully developed and implemented in a highly complex environment such as the nations' largest public school system," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "Testing is one component of the multiple mitigation steps developed by New York City, which include real time results reporting to the city situation room, closure protocols, social distancing, masks and ventilation improvements. These measures taken by the city and the teachers' union resulted in a very low COVID-19 rate of infection within the school system for those individuals tested by BioReference. We are proud to be one of the partners that helped in this effort to have children return to school and continue to learn in a safe environment."
On September 2, BioReference began working with New York City to COVID-19 PCR test principals, teachers and staff in preparation for a safer back-to-school environment. Prior to the start of the 2020-2021 school year, BioReference tested 8,913 individuals, with an average turnaround time of less than 24 hours.
Subsequently, BioReference and New York City expanded the school testing program to include students on October 9. Sixty-four teams visited almost 200 schools per day, having tested 209,790 individuals in more than 1,200 schools with an average turnaround time of less than 38 hours. Among the total individuals tested, 975 (0.47%) were positive for COVID-19.
COVID-19 positivity rates by borough were; Manhattan: 0.37%, Brooklyn: 0.45%, Queens: 0.38%, Staten Island: 0.52% and Bronx: 0.71%. Interestingly, the rate for students and teachers, principals and staff were similar and very low (less than 1%).
About BioReference Laboratories, Inc.
BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions, and medical groups. BioReference developed and offers test services that yield high quality and accurate results, including a molecular test for helping with COVID-19 diagnosis and a serology test to help indicate possible COVID-19 exposure. The company is in network with the five largest health plans in the United States, operates a network of 11 laboratory locations, and is backed by a medical staff of more than 120 M.D., Ph.D. and other professional level clinicians and scientists. With a leading position in the areas of genetics, women's health, maternal fetal medicine, oncology, and urology, BioReference and its specialty laboratories, GenPath and GeneDx, are advancing the course of modern medicine. For more information, visit www.bioreference.com.
Easy double digits once we approach Oct 2020. $275m milestone and instant profit sharing.
They probably will PR it with Rayaldee CKD 5 trial news
It is Pfizer who filed the BLA. They probably know everyone in FDA
Finally
Novel SARS-CoV-2 variant in UK estimated to be 56% more transmissible than other strains. Children may also be more susceptible to this new strain.
https://cmmid.github.io/topics/covid19/reports/uk-novel-variant/2020_12_23_Transmissibility_and_severity_of_VOC_202012_01_in_England.pdf
Testing not going away soon https://twitter.com/bbc5live/status/1345006866829463552?s=19
Buffalo Bills and OPKO Health's BioReference Laboratories Initiate the First Large Scale, Mandatory COVID-19 Fan Testing Program
Download as PDFDecember 31, 2020
The Bills leverage testing capabilities from NFL testing provider, BioReference, to initiate fan testing program
ORCHARD PARK, N.Y., Dec. 31, 2020 /PRNewswire/ -- Buffalo Bills, 2020 AFC East Division Champions, and BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), today announced they will be performing fan testing for the AFC Divisional Wild Card playoff game at Bills Stadium in Orchard Park.
BioReference Laboratories, Inc., an OPKO Health Company. (PRNewsfoto/BioReference Laboratories, Inc)
Through New York State, the Bills have been granted permission to host fans at their home Wild Card game that will be played on Jan. 9 or 10. All fans will be required to obtain a negative COVID-19 PCR laboratory-based test result within 72 hours of the game through the NFL's testing partner, BioReference, in order to attend the game. Fans that purchase a ticket will be given a BioReference URL to select a testing time at Bills Stadium, two or three days prior to game day.
"BioReference has been helping our players, coaches and staff stay safe all season," said Kim Pegula, Bills Owner and President. "We have no doubt they will help create a safe environment for our long awaited home playoff game. We are pleased to expand our partnership to bring fans back into the stadium."
"The Bills, New York State and BioReference are committed to providing a safe environment so that fans can enjoy the playoff game," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "BioReference has led the way in providing customized large scale COVID-19 screening programs to organizations and municipalities across the country. Fan testing is the next natural step in helping Americans attend and enjoy live sporting and entertainment events."
"Bills fans have waited decades in order to attend a home playoff game and we have worked to build an innovative pilot program to make that happen safely," Governor Cuomo said. "All season long, the Bills' stellar play has captured a certain energy and charisma that is undoubtedly infectious, but we all need to be smart. We're in control of our destiny and how we act is going to determine what comes next. So while this is a time for excitement and celebration, it's critical that everyone follow the guidelines and practice the safe behaviors we know work. If everyone does their part, I believe this pilot will be successful. Go Bills!"
About BioReference Laboratories, Inc.
BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions, and medical groups. BioReference developed and offers test services that yield high quality and accurate results, including a molecular test for helping with COVID-19 diagnosis and a serology test to help indicate possible COVID-19 exposure. The company is in network with the five largest health plans in the United States, operates a network of 11 laboratory locations, and is backed by a medical staff of more than 120 M.D., Ph.D. and other professional level clinicians and scientists. With a leading position in the areas of genetics, women's health, maternal fetal medicine, oncology, and urology, BioReference and its specialty laboratories, GenPath and GeneDx, are advancing the course of modern medicine. For more information, visit www.bioreference.com.
About OPKO Health
OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding BioReference's testing, the availability of testing and the role and value of the information provided and its impact on decisions, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.