Seeking37 here're some interesting assessments.
"Leronlimab is a best of breed drug that can be given with a simple subcutaneous injection (not in-hospital IV) and operates in the spectrum from moderate to “people at death’s door.” Leronlimab is the only severe to critical drug that got a DSMC green light to proceed without any changes. Big pharma drugs are struggling as it is and don’t stand a chance after leronlimab is approved."
**********************
"Since CytoDyn finished its trial it is going after a full approval in severe to critical COVID-19.
"With a mortality benefit, they will be the new standard of care.
"Humanigen cannot compete with this and will have to play second fiddle to possible therapeutic rationing of leronlimab.
"The value of a drug approval is clearly not baked into CtyoDyn’s stock price. The company has a $2.0 billion market cap yet in the next 30 days it could sell $2.0 billion of product if they get an EUA from either the Philippines, the United Kingdom, or the United States.
"The most likely scenario is that CYDY turns into a Gilead like big pharma with dozens of indications and Humanigen gets gobbled up by another big pharma to compete against the biggest little pharma called CytoDyn.
Investors that fail to heed this call on CYDY won’t be missing the train they will be missing the rocketship. The CEO of CytoDyn said don’t blink or you will miss it.
"Investors without a full position in CYDY just blinked. HGEN could be a great hedge in this therapeutic area, but most investors like to buy the best in breed and that is CytoDyn.
*******************************
"There should also be a corresponding reset higher in the price of CytoDyn since they are the beneficiary of being the first to market and have outlasted all their competition.
"They even have 3 shots on goal in this upcoming trial readout. Their primary endpoint is 28 day mortality, their revised secondary endpoint is 42 day survival, and change in clinical status on a 7 point ordinal scale.
"Meeting just one of these endpoints is a layup for approval(FDA) but it’s likely that they will meet all of them.
"As the ONLY drug with a mortality benefit, they are almost guaranteed to be the new SOC.
"This will dramatically impact Gilead Sciences (NASDAQ: GILD) and their sales of remdesivir. CytoDyn might also get a label expansion in moderate COVID-19 and long haulers. They have a clinical trial for long haulers that could be started imminently. All these factors combined equate to a doubling of market cap and a doubling of price.
"If CYDY gets approval they have a GvHD indication and the new standard of care(SOC) for COVID-19.
"CYDY has a much brighter future because it is a platform technology with strong indications in COVID-19, longhaulers, cancer, NASH, stoke, and HIV. The best way for MESO shareholders to make their money back is to buy the best stock – CYDY.
***********************
"To the best of our knowledge, we are the first company to complete a Phase 3 trial for COVID-19 severe-to-critical population".
"11/17 PR was LH(long hauler) Phase 2 trial protocol successfully filed with FDA for 102 patients at 10 sites.
"The Centers for Medicare and Medicaid Services (CMS) released 21 new ICD-10-PCS codes that apply to the vaccination or treatment of COVID-19. These codes are effective January 1, 2021....leronlimab"
XW013K6)
https://www.icd10monitor.com/cms-releases-new...r-covid-19
************************
Dec.17, 2020
https://insiderfinancial.com/rise-of-the-covi...en/180780/
Dec.18, 2020
https://emerginggrowth.com/mesoblast-crashed-...rapeutics/
April 30,2020 - emergency Investigational New Drug (eIND) program/compassionate use
https://www.targetedonc.com/view/close-to-50-...ny-recover
Dec.23, 2019 - MBC, mTNBC
https://www.globenewswire.com/news-release/20...rials.html
"Leronlimab is a best of breed drug that can be given with a simple subcutaneous injection (not in-hospital IV) and operates in the spectrum from moderate to “people at death’s door.” Leronlimab is the only severe to critical drug that got a DSMC green light to proceed without any changes. Big pharma drugs are struggling as it is and don’t stand a chance after leronlimab is approved."
**********************
"Since CytoDyn finished its trial it is going after a full approval in severe to critical COVID-19.
"With a mortality benefit, they will be the new standard of care.
"Humanigen cannot compete with this and will have to play second fiddle to possible therapeutic rationing of leronlimab.
"The value of a drug approval is clearly not baked into CtyoDyn’s stock price. The company has a $2.0 billion market cap yet in the next 30 days it could sell $2.0 billion of product if they get an EUA from either the Philippines, the United Kingdom, or the United States.
"The most likely scenario is that CYDY turns into a Gilead like big pharma with dozens of indications and Humanigen gets gobbled up by another big pharma to compete against the biggest little pharma called CytoDyn.
Investors that fail to heed this call on CYDY won’t be missing the train they will be missing the rocketship. The CEO of CytoDyn said don’t blink or you will miss it.
"Investors without a full position in CYDY just blinked. HGEN could be a great hedge in this therapeutic area, but most investors like to buy the best in breed and that is CytoDyn.
*******************************
"There should also be a corresponding reset higher in the price of CytoDyn since they are the beneficiary of being the first to market and have outlasted all their competition.
"They even have 3 shots on goal in this upcoming trial readout. Their primary endpoint is 28 day mortality, their revised secondary endpoint is 42 day survival, and change in clinical status on a 7 point ordinal scale.
"Meeting just one of these endpoints is a layup for approval(FDA) but it’s likely that they will meet all of them.
"As the ONLY drug with a mortality benefit, they are almost guaranteed to be the new SOC.
"This will dramatically impact Gilead Sciences (NASDAQ: GILD) and their sales of remdesivir. CytoDyn might also get a label expansion in moderate COVID-19 and long haulers. They have a clinical trial for long haulers that could be started imminently. All these factors combined equate to a doubling of market cap and a doubling of price.
"If CYDY gets approval they have a GvHD indication and the new standard of care(SOC) for COVID-19.
"CYDY has a much brighter future because it is a platform technology with strong indications in COVID-19, longhaulers, cancer, NASH, stoke, and HIV. The best way for MESO shareholders to make their money back is to buy the best stock – CYDY.
***********************
"To the best of our knowledge, we are the first company to complete a Phase 3 trial for COVID-19 severe-to-critical population".
"11/17 PR was LH(long hauler) Phase 2 trial protocol successfully filed with FDA for 102 patients at 10 sites.
"The Centers for Medicare and Medicaid Services (CMS) released 21 new ICD-10-PCS codes that apply to the vaccination or treatment of COVID-19. These codes are effective January 1, 2021....leronlimab"
XW013K6) https://www.icd10monitor.com/cms-releases-new...r-covid-19
************************
Dec.17, 2020
https://insiderfinancial.com/rise-of-the-covi...en/180780/
Dec.18, 2020
https://emerginggrowth.com/mesoblast-crashed-...rapeutics/
April 30,2020 - emergency Investigational New Drug (eIND) program/compassionate use
https://www.targetedonc.com/view/close-to-50-...ny-recover
Dec.23, 2019 - MBC, mTNBC
https://www.globenewswire.com/news-release/20...rials.html
5
