Ann: FDA Accepts BLA for RYONCIL and Agrees to Priority Review, page-122

Anjo-Roch posted this yesterday , It may have been missed by some due to so much happening , But it contains lots of positives and worth a reread ..How can the sp retract after seeing this !! .......................... Years of work in stem cell therapy technology by Mesoblast could soon be used to help COVID-19 patients in the United States facing the final and worst phase of the virus.Australia is well known for its leadership in medical science thanks to the genius and determination of individuals working in a sector that consumes enormous amounts of development capital.

Mesoblast chief executive Silviu Itescu stands out among his peers for his long term commitment to innovation in stem cell research.This paid off on Monday when the company said it had clearance from the US Food and Drug Administration (FDA) for an Investigational New Drug application to treat patients with acute respiratory distress syndrome (ARDS) caused by COVID-19.

Mesoblast's Silviu Itescu could soon be seeing the benefits of years of research in COVID-19 patients. David RoweThe treatment involves intravenous infusions of its allogeneic mesenchymal stem cell (MSC) product candidate Remestemcel-L.

It says a lot about the depth and breadth of the coronavirus disaster in the US that the FDA was willing to move so quickly to approve the use of the Mesoblast treatment on US patients.The worst phase of COVID-19 occurs when the patient suffers a cytokine storm which is an overproduction of immune cells and their activating compounds (cytokines). The resultant surge of activated immune cells into the lungs causes inflammation and fluid build-up that can lead to death.The death rate among COVID-19 patients with inflammatory lung condition acute respiratory distress syndrome is about 50 per cent.

Mesoblast said on Monday Remestemcel-L "is believed to counteract the inflammatory processes implicated in these diseases by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues".

Itescu's genius was to find possible applications of Remestemcel-L from a review of a relatively small but significant study conducted in China earlier this year into COVID-19 patients.The investigator-initiated clinical study reported that allogeneic MSCs cured or significantly improved functional outcomes in all seven treated patients with severe COVID-19 pneumonia.

The FDA was quick to allow Mesoblast to start an investigational study of COVID-19 patients in the US because it was already being used in a number of clinical trials in the US across several inflammatory conditions, including in elderly patients with lung disease and adults and children with steroid-refractory acute graft versus host disease (aGVHD).The product candidate was being reviewed by the FDA for potential approval in the treatment of children with steroid-refractory aGVHD.

In other words, the possibility of saving COVID-19 patients facing the dire situation of cytokine storms in their lungs is because of more than a decade of commitment and hundreds of millions of dollars invested in research and development which was funded by Australia's equity capital market.......,................The FDA know what this company is all about ...Cheers