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Perhaps the slide is due to a matter of presentation.
RLFTF"s frontman has a medical "pedigree".
The trials are being done in conjunction with NeuroRx, whose principal's bio is below, what an impressive background.
Chief Executive Officer Jonathan C. Javitt, M.D., M.P.H.
Dr. Javitt has played leadership roles in seven successful healthcare IT and biopharma startups with public exits. He has additionally led drug-development engagements for Merck, Allergan, Pharmacia, Novartis, and Pfizer. He was appointed to healthcare leadership roles under Presidents Reagan, George H.W. Bush, Clinton, and George W. Bush. In the latter role he was commissioned to lead the White House policy for universal adoption of Health IT and establishment of the Office of the National Coordinator. He is a graduate of Princeton University, Cornell University Medical College, Harvard School of Public Health, the Wills Eye Hospital, and Johns Hopkins Medical School . Dr. Javitt has published more than 200 scientific works in the areas of health outcomes and pharmacoeconomics that have been cited by more than 16,000 people.
And have you listened to him -
https://www.youtube.com/watch?v=lgmpS2N8124
Meanwhile BPSR has -
EXECUTIVE LEADERSHIP
Albert Mitrani
CEO & Co-Founder
Board Member
Dr. Maria Ines Mitrani, M.D., PhD
CSO & Co-Founder
Board Member
George Shapiro, M.D., FACC
Chief Medical Officer
Board Member
Ian T. Bothwell
Chief Financial Officer
Board Member
SCIENCE & REGULATORY ADVISORY BOARD
Michael A. Bellio, Ph.D.
Vice President, Manufacturing & Processing
Ivan Santos
Research & Development Scientist
Julian Milberg
Process Engineer
Zanub Abdullah
Cell Processing Specialist
MEDICAL ADVISORY BOARD
Allen J. Meglin, M.D.
Medical Director, Board Member
Bryan Kelly, M.D.
Medical Advisor
Carolyn DeLucia, M.D.
Medical Advisor
Paul Thompson, M.D.
Medical Advisor
Marianne LaBarbera, M.D.
Medical Advisor
Paul Francis Campion, M.D.
Medical Advisor
Sonita Sadio, M.D.
Medical Advisor
Henry C. Sobo, M.D.
Medical Advisor
Rolf Wallin, M.D.
Medical Advisor
Dr. Robert Madda, M.D.
Medical Advisor
Raymond Ishman, M.D.
Medical Advisor
William K. Kapp III, M.D., M.S., FAAOS
Medical Advisor
Stephanie M. Singer, D.O.
Medical Advisor
Dr. Julian Gershon, D.O.
Medical Advisor
Rebecca Murray, F.N.P.
Medical Advisor
Juan Chavez, M.D.
Medical Advisor
Fernando Pinto, M.D.
Medical Advisor
Michale J. Barber, M.D.
Medical Advisor
Alvaro J. Ocampo, M.D. MPH
Medical Advisor
David C. Socol, M.D.
Medical Advisor
John R. Baird, M.D.
Medical Advisor
Ken Sharlin, M.D., M.P.H., IFMCP
Medical Advisor
Randolph Whipps, M.D., F. A.C.C.
Medical Advisor
Riley J. Williams III, M.D.
Medical Advisor
Barry Kuttner, M.D., PhD
Medical Advisor
Mounir Wassef, D.O., FAOCD, FAAD
Medical Advisor
Robert Neal Rouzier, M.D.
Medical Advisor
Bennett L. Willard, D.O.
Medical Advisor
Dan Sperling, M.D., D.A.B.R.
Medical Advisor
Glenn Charles, D.O.
Medical Advisor
Eugene Rajaratnam, M.D., F.A.C.S.
Medical Advisor
Matthew Lief, M.D., F.A.C.S.
Medical Advisor
Josh Sandell, D.C., D.A.C.B.S.P., A.T.C., C.S.C.S., I.C.S.S.D.
Medical Advisor
Billy Ray Ledbetter, M.D.
Medical Advisor
Mohammed Siddiqui, M.D.
Medical Advisor
Matthew Burnett, D.C., C.C.S.M.S, C.F.S.S.
Medical Advisor
FINANCIAL & REGULATORY
ADVISORY BOARD
Larry Ziff
Financial and Regulatory Advisor
STRATEGIC ADVISORS
Raymond Zoeller
Strategic Advisor
Humanigen, HGEN is here -
https://www.humanigen.com/about-humanigen
Landmark Hospitals Compassionate Use Study for Critical COVID-19 Patients Evidences Potential for Allogenic Biologic Product
MAY 30, 2020 | ALLOGENIC BIOLOGIC PRODUCT, ARDS, CORONAVIRUS, COVID-19, CYTOKINE STORM, INVESTOR WATCH, POPULAR POSTS, REGENERATIVE MEDICINE, SARS-COV-2, STEM CELL
Landmark Hospital manages six long-term acute care hospitals across the Southeast United States and recently announced its decision to offer an investigational allogenic biologic product derived from amniotic fluid to patients with advanced COVID-19 conditions under the U.S. Food and Drug Administration (FDA) approved Compassionate Use pathway. Two patients at Landmark Hospital of Athens, Georgia, were treated last week with the first doses of the regimen, known as Organicell Flow. Reports are that intravenous infusions of the biologic product were administered safely to the two patients, and they are clinically stable.
A Key Challenge with COVID-19
The majority of COVID-19 cases are mild, with flu-like conditions for a couple of weeks. However, when cases of COVID-19 do escalate into severe and critical cases, the risk significantly rises for organ damage and death. While the world waits for a safe and effective vaccine, If safe and effective treatments are developed for this class of patient—in addition to the development of safe and effective products for the mild cases—then the overall risk of COVID-19 becomes mitigated until the vaccine is approved.
All of this is important as worldwide experiences direct the medical community to the risks of the severe to critical cases of COVID-19—where a progressive decline in lung function represents a major cause of death in patients infected with SARS-CoV-19; those patients who are admitted into the ICU and thereafter require intubation face high mortality rates. Finding a number of effective and safe ways to treat this patient class, including those with severe Acute Respiratory Distress Syndrome (ARDS) and the overall pandemic risk, wanes as the mortality rate will decline. Hence the importance of the Landmark Hospitals Compassionate Use case discussion.
A Possible Treatment for the ‘Cytokine Storm’?
With severe to critical cases of COVID-19 comes the need for oxygen therapy, mechanical ventilation, and medications to maintain the patient’s blood pressure, reported Landmark Hospitals in a recent press release. But patients at this stage of the disease, especially if they have other risk factors or comorbidities, are at risk of their condition escalating into the so-called cytokine storm. CEO William K. Kapp III, MD, Landmark Hospitals founder, commented, “COVID-19 patients can experience immune activation and the appearance of the cytokine storm syndrome (CSS), which causes damage to lungs and other organs and can lead to death. Landmark Hospitals obtained Compassionate Use approval to administer Organicell Flow because previously collected research showed it might have therapeutic potential in reducing the cytokine activation cycle, which will impact COVID-19 infection severity.”
What is Organicell Flow?
Manufactured by Organicell Regenerative Medicine, Inc., this is a novel treatment derived from human amniotic fluid (HAF) that is voluntarily donated during planned Caesarean section surgeries. The product contains over 300 growth factors, cytokines, and chemokines, as well as hyaluronic acid exosomes.
Is there any comparable treatment on the market for COVID-19?
No. There is currently no specific antiviral therapy available for patients with COVID-19. The FDA-approved Compassionate Use pathway allows for the immediate use of the experimental biologic.
Is this effort like a Clinical Trial?
Yes, it is. The product hasn’t been approved for marketing via the standard process (e.g., three clinical trial phases, filing for marketing, etc.). The product’s maker, Organicell, received Emergency Compassionate Use Investigational New Drug applications (eINDs) by the FDA.
Moreover, as Dr. Kapp quoted in his firm’s press release, Landmark Hospital Athens will be collecting patient data (again under Compassionate Use) and perform ongoing analysis as to the impact—the affect on the two patients—and thus “guide us to interventions that modulate COVID-19 immune response in the lungs and reduce systemic organ damage.”
What are some more details on this Compassionate Use eIND use case?
Upon FDA eIND approval, Landmark Hospital immediately treated the two critically ill COVID-19 patients, in their mid-70s, with the biologic product.
What have been the results thus far?
Landmark Hospital reports that the two patients are clinically stable while the vendor, Organicell, reported in their press release that “Organicell Flow resulted in a remarkable improvement in their clinical status, lung and renal function confirmed by follow up chest X-rays and lab data.” For example, they report that “the patients are no longer intubated” and appear more alert with positive vital signs and oxygenation. Moreover, at least as of this writing, there doesn’t seem to be the organ damage associated with many SARS-CoV-2 cytokine storm cases.
Has Organicell Flow met its primary and secondary endpoints for the Compassionate Use eIND?
Yes. Dr. George Shapiro, Chief Medical Officer of Organicell, reported: “We are very pleased that Organicell Flow, administered intravenously, has to date met all of the primary objectives of safety and secondary clinical objectives of improved ICU status and reduction in the sequential organ failure assessment (SOFA) score.”
Meanwhile, from the provider (site) perspective, Dr. Anthony Sagel, Chief Medical Officer at Landmark Hospital, reported that “The first patient has improved considerably and is now off the ventilator with normal-appearing lungs on their chest X-ray. In addition, their mental status continues to improve with normal kidney function. The second patient has also been systemically improving, including their kidney and respiratory function. Their acute delirium has improved and is communicating well with the family. Both patients are ready to be discharged from the ICU.”
What are the next steps?
The clinical trial protocol established under the eIND is that each of the patients will continue to be monitored on their health vitals for 60 days. Based on the continued favorable results, the product developer, Organicell, may seek other approvals from the FDA to treat other severely ill patients. They will need to do this with the FDA on a case by case basis. Note, the company has registered an FDA-compliant clinical trial with Landmark Hospitals.
The Forthcoming Study
The forthcoming Phase I/II study, sponsored by Organicell, is led by Landmark Hospitals with the purpose to evaluate the safety and potential efficacy of Intravenous Infusion of Organicell Flow for treatment of moderate to Severe Acute Respiratory Syndrome (SARS) related to COVID-19 infection vs. placebo. Scheduled to start in May 2020, the study will run through December 30, 2020. The Principal Investigators will combine Dr. Kapp from Landmark with Dr. Mitrani and Dr. Shapiro from Organicell.
The Product
Organicell Flow is a natural and acellular product derived from amniotic fluid and is manufactured to retain the naturally occurring hyaluronic acid, proteins, and exosomes present in perinatal fluid without the addition or combination of a substance or diluent. Organicell products are manufactured in cGMP compliant labs and are tested for sterility, endotoxin levels, hyaluronic acid, protein analysis, and exosomes composition. Exosomes are nano-sized extracellular vesicles that mediate cell-to-cell communication and affect cell function and behavior. For an overview of the science of the product, see this link.
Organicell Regenerative Medicine, Inc.
Publicly traded, Organicell was founded in 2008 by Albert Mitrani, Chief Executive Officer, and Dr. Mary Mitrani, Chief Scientific Officer. Based in Miami, Florida, Organicell is a clinical-stage biopharmaceutical company that harnesses the power of exosomes to develop innovative biological therapeutics for the treatment of degenerative diseases. The company’s proprietary products are derived from perinatal sources and manufactured to retain the naturally occurring exosomes, hyaluronic acid, and proteins without the addition or combination of any other substance or diluent. With under 25 employees, they have three COVID-19 product initiatives in their growing pipeline. With clinical trials, the company previously collaborated with the University of Miami to complete pre-clinical studies in therapeutic areas such as pediatric pulmonary disorder.
A Challenged Past
Publicly traded in the form of a penny stock type of equity asset class, the company must disclose material information to the Securities Exchange Commission (SEC). In their latest 10K, those investors interested can read about the company—how it has faced a tumultuous past attempting to navigate an increasingly regulated world involving the business of selling and distributing regenerative biologic therapies based on proprietary amnion placental tissue-derived products to doctors and hospitals. With toughening regulatory stances from the FDA, (see Section 351 of the Public Health Services Act) the company, on the one hand, was making considerable scientific breakthroughs; but on the other hand, it was short on capital and business talent. The financial considerations are beyond the sphere of this article, but suffice to say the fact that the company is still around to attempt to save COVID-19 patient lives is a testimony to the survival instincts of its two founders (who happen to be spouses)—Albert Mitrani and Dr. Maria Mitrani. 69.48% of this company is controlled by the company’s Board and executive officers Manuel E. Iglesias—via MBC LLC, and executive officers Albert Mitrani, Dr. Maria Mitrani as well as Ian T. Bothwell and Robert Zucker. For those that seek a case study in business intrigue, read the annual statement.
About Landmark Hospitals
Established to form regional hospital referral centers for medically complex patients in need of intensive post-acute care, they established their first regional long-term acute care hospital in Cape Girardeau, Missouri, in 2006 and has steadily grown to seven facilities in four states. They are comprised of the seven operational hospitals, each of which was built in the last eight years. They operate in Missouri, Georgia, Utah, and Florida.
The Organicell Flow Study Lead Research/Investigator
Dr. William Kapp, MD, FAAOS
Call to Action: TrialSite News will monitor the Landmark Hospitals and forthcoming study carefully. The data points currently from the Compassionate Use are only two patients, so no conclusions can be derived. However, if the study commences and most, if not all, of the 20 patients targeted do well, then it becomes more probable that Organicell is on to something special.
https://www.trialsitenews.com/landmark-hospitals-compassionate-use-study-for-critical-covid-19-patients-evidences-potential-for-allogenic-biologic-product/
Dr. WilliamKapp is an orthopedic surgeon based in Naples, FL. He is currently the Chairman and CEO at Landmark Hospitals, the CEO of the Technomad, the CEO of the Longevity Performance Center, and the CEO of the Longevity BioImaging Center. He is also an active surgeon at the Landmark Hospital of SW Florida. He is a physician who specializes in the diagnosis and surgical treatment of injuries and disorders involving the musculoskeletal system, such as hip replacements and arthroscopic knee surgery.In addition to treating trauma to the musculoskeletal system.Dr. Kapp also treats sports injuries, degenerative diseases, infections, tumors, and congenital disorders. His experience as a Flight Surgeon in the Air Force enabled him to provide support to pilots in examinations (flight physicals) and areas other than those solely based on orthopedic situations. His continuing role as a private pilot ensures that prevention is as important as corrective surgery.
Interest that the other trial is in Russia.
https://clinicaltrials.gov/ct2/show/NCT04491240?term=Organicell&draw=2&rank=2
Also Therametrics popped 150% today also.
https://finance.yahoo.com/quote/0QKQ.L/profile?p=0QKQ.L
2.11B outstanding, no worries, I suspect a significant amount may be held by it's parent company, Therametrics Discovery AG. https://www.dnb.com/business-directory/company-profiles.therametrics_discovery_ag.7be6c3a0d8a048cdb715797673005b9b.html#related-companies
https://www.acxit.com/en/therametrics-relief/
The trials are being done in conjunction with NeuroRx, whose principal's bio is below, what an impressive background.
Chief Executive Officer Jonathan C. Javitt, M.D., M.P.H.
Dr. Javitt has played leadership roles in seven successful healthcare IT and biopharma startups with public exits. He has additionally led drug-development engagements for Merck, Allergan, Pharmacia, Novartis, and Pfizer. He was appointed to healthcare leadership roles under Presidents Reagan, George H.W. Bush, Clinton, and George W. Bush. In the latter role he was commissioned to lead the White House policy for universal adoption of Health IT and establishment of the Office of the National Coordinator. He is a graduate of Princeton University, Cornell University Medical College, Harvard School of Public Health, the Wills Eye Hospital, and Johns Hopkins Medical School. Dr. Javitt has published more than 200 scientific works in the areas of health outcomes and pharmacoeconomics that have been cited by more than 16,000 people.
See his interview here -
My response was to another post which mentioned the Drs. Javitt brothers, who are involved with NeuroRx. I am aware of RLFTF, and I find 2.11B somewhat scary.
Or was it MRNA ? but definite deja vu.
Extract from AMRN latest 10Q.(End of August will soon be here.)
In January 2020, Acasti announced topline results of the TRILOGY 1 trial of CaPre. The study did not reach statistical significance and further analysis in underway. In April 2020, Acasti announced that it filed a meeting request with the FDA to discuss the TRILOGY 1 data and align on the interpretation of the results. Acasti also will seek FDA input on revisions to the pre-specified TRILOGY 2 statistical analysis plan, or SAP, and on a plan for pooling the data from TRILOGY 1 and TRILOGY 2 in support of an NDA filing. Acasti stated that it received a written response from the FDA in June 2020 confirming that the FDA will require pivotal efficacy analyses for TRILOGY 2 to be performed on the full Intent to Treat population as per the original SAP and supporting Acasti’s conduct of exploratory post-hoc analyses in TRILOGY 1, depending on the outcome of TRILOGY 2.
Accordingly, Acasti may be required to conduct an additional clinical trial before submitting an NDA. Acasti also stated that they expect to announce topline results of TRILOGY 2 at the end of August. NDA submission (if any) and resultant review/approval timelines will be announced following completion of TRILOGY 1 and 2 data analysis.
Didn't this not happen a week or 2 ago with GILD ?
NeuroRX is private.
Not the first to market, but once they got in, they took leadership of the segment. For the August 31 price, I'll go with $480.00
Last time I did a prediction - July 2, I said $420 which was a miss by $5.66
morokoy Member Level Thursday, 07/02/20 03:45:05 PM
Re: Bigman7100xxx post# 134581 0
Post # 134586 of 135029
July 31, $420
That probably explains the 93.5M shares traded vs the average of 33.5M according to NASDAQ https://www.nasdaq.com/market-activity/stocks/aapl
Guess there was a lot of profit taking, so the Robinhood folks are going to get screwed. I am looking to buy at around $412 or sub $400 and hold until around 9/15, and hopefully sell some of the bonus at $110
Reason - am buying to round out an odd lot situation that the bonus will cause, plus make a few $$ on the trade. Not much, just about 270.
My statement for 5/31/14 shows a price of $633.00
Statement at 6/30/14 shows $92.93 x7 = $650.51
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Is this the biggest one day jump ? And look at volume, 2x the average.
Agree with you summation. Get $25M from discounted note of $28.5M, so that's a cost of $3.5M, then after 1 year interest is $2.85M, so a return of $6.35M on $25M is 25.4% - now it begins to add up.
My guess is $7.50 tops tomorrow, and the CC is a nothing burger. Stay tuned for a future update.
Mostly covered calls.
TDA offers a very esoteric options trading menu, including vertical and calendar put and call spreads. I generally give purchasing preference to a stock that a) trades options b) pays a dividend. To reduce angst, it should trade weekly options. AAPL is ideal for this, and I increase my odds by only trading on a Wednesday, so you basically have a two and a half day exposure.
No, the post is accurate. https://www.bop.gov/inmateloc/
It's just that he conviently left off the middle initial Z.
Like Michael Jordan the basketballer, while the actor is Michael B. Jordan.
Was there any particular reason you did not use the Middle initial "Z"
Was it because that turns up
0 Results for search Nader Z Pourhassan
If you have a Roku device, you add Pluto TV, and it is one of the stations in the News section.
I wrote this to a friend last Monday -
I see doom and gloom for another venerable banking company with 4.1 Billion shares outstanding. Wells Fargo Co (WFC) the Fed recently curtailed their exuberance at paying an increased dividend, and last week they announced a 10,000 job cut. I suspect it will be at least twice that.
Then we see this -
Wells Fargo has more than $1 trillion of VIE assets, about which we currently know very little, because reporting requirements are opaque.
There is going to be a lot of grief to share around.
Needless to say, I am not a fan of any financial stock.
Indeed, that is a whole lot more than India's 1.98
You have something against Bulgarians ?
Mr. Naydenov has been a Director of CytoDyn since June 2009. For more than 20 years, Mr. Naydenov has been actively involved in innovative developments in a variety of fields, ranging from sports, fitness, & health to robotic technology. Since 2001, Mr. Naydenov has served as the Vice President and Director of Milara Incorporated, a leading and multi-faceted company that specializes in wafer-handling robotics, semiconductor systems, and surface mount technologies. In 2006, Mr. Naydenov became the Treasurer of Milara Inc., and additionally began serving as the Director of Milara International, the international representative of Diamond and Equipe brands of Semiconductor Robotics & Systems. Since then, Mr. Naydenov has expanded his experience in innovative developments and industries, with his most recent endeavor beginning in 2017 as the founder of the natural health care product company, Pure Care Pro LLC.
http://www.milarasmt.com
You are correct, it is old. So perhaps July 17 from Johns Hopkins is more appropriate - 1.89 per 100,000 so that's say 19 per million.
https://coronavirus.jhu.edu/data/mortality
Don't think India will need it, they are not in the top 10 for deaths per 100,000. As a matter of fact Mexico is at No. 9 with 17.90 per 100,000, while India's 17 per deaths is per Million.
https://www.statista.com/chart/21170/coronavirus-death-rate-worldwide/
Most interesting about Gilead, Donald Rumsfeld (later 21st Secretary of Defense) was a director from 1988, and served as Chairman from January 1997 to January 2001.
There were 2 responses both saying no monotherapy subject had contracted Covd 19.
Found on another message board site.
Re: Interim Analysis - Jack
I've been involved in a couple of clinical trials and Luckjack has the interim analysis basically right. The company and clinical investigators are not unblinded. If they were it would end the trial. Only the DSMB is unblind to the results and they communicate with the company only in a few written yes/no responses (a faxed single sheet of paper with boxes checked in the trials I was involved with).
There is usually a futility analysis made by the DSMB and getting past that means something. That is, the DSMB looks at the results and their statistician makes a determination of whether the trial could possibly meet its endpoints with statistical significance if allowed to continue. For example, if a trial were half way done and there was no or very minimal separation between the treatment and control groups, then the statistics might show the trial could not possibly meet its endpoints. The company would be told that (Is it futile? yes/no) and in every case I know of that would cause the company to end the trial. So what we know is that that did not happen.
Liver transplant patient.
And it seems that Cheval Holdings owns 69 million shares of it.
https://whalewisdom.com/filer/cheval-holdings-ltd
Sarah Gray Wright passed away.
https://www.bbc.com/news/uk-england-kent-52836125
Agree 100% with you. It is also on his website.
https://drmalcolmkendrick.org/2020/07/05/distorting-science-in-the-covid-pandemic/
I would not be surprised if the FDA pulled an AMARIN on them and said o.k. lets wait on the 390 trial.
How much can CYDY match in political contributions against BP.
The question that needs to be asked, is - Does the agreement give Vyera the right to price leronlimab ?
As you may know, Vyera was the vehicle of Martin Shkreli, who is well known for raising the price of drugs under his control.
Vyera is now under the umbrella of Phoenixus.
https://www.thedailybeast.com/martin-shkreli-still-running-his-drug-company-phoenixus-ag-from-behind-bars-report
Martin Shkreli, the disgraced pharmaceutical executive, continues to run his company from prison with the help of a contraband cellphone, The Wall Street Journal reports. Shkreli was sentenced to seven years in prison last year for defrauding investors in his hedge funds and for manipulating the stock of his pharmaceutical company. The company, Phoenixus AG, brought to light the industry-wide practice of hiking up the prices of rare drugs. Shkreli jacked up the price of one HIV drug from $13.50 to $750. The so-called “pharma bro” recently fired his handpicked chief executive over the phone while he was on vacation, according to a source familiar with the exchange.
Shkreli plans to emerge from jail richer than he entered. According to his own calculations, Phoenixus could be worth $3.7 billion by the time he is freed in 2023. For that to happen, Shkreli plans to acquire more rare drugs in various stages of development and invest in ambitious research and development. The incarcerated executive reportedly spends his time reading pharmaceutical research on the inmate computer lab or on his phone.
For a bit of history, wikipedia is a great read.
https://en.wikipedia.org/wiki/Vyera_Pharmaceuticals
Also see-
https://www.bloomberg.com/opinion/articles/2020-01-30/slapping-around-martin-shkreli-won-t-cut-drug-prices
https://www.cnbc.com/2019/04/24/pharma-bro-martin-shkreli-moved-from-prison-after-rule-breaking.html
July 31, $420