Mesoblast gets one more roll of the dice, page-17

The figures do not indicate how swiftly the market took up the offering, finished by the middle of the day offered. If Mesoblast was in some way suspect that would not be the case.

Mesoblast was well funded for a release later this year of the same core product for a much smaller demand, after over a decade of development, trialling and submission to the rigours of the FDA approval process.

Times are more urgent, the FDA is now using legislation used to help strengthen the US public health protections against CBRN (Chemical, Biological, Radiological and Nuclear threats) by facilitating the availability and use of MCMs (Medical Counter Measures) needed during public health emergencies. The cellular medicine (not a vaccine) has shown great promise in trials over the past decade in combating the cytokine storm that is a hall mark of the lethal stages of COVID-19. To prove to the FDA the cellular medicine remestemcel-L is capable of preventing death by all causes attributable to COVID-19 it is being put through a rigorous but brief (by normal FDA standards) final trial.

The first probable time the trial may be halted is likely to be some time in June. If that happens and the FDA issues an Emergency Use Authorization then Mesoblast will need to be able to supply remestemcel-L in significant quantity, a lot more than had been budgeted for only 3 or 4 months ago, and it takes time to build new facilities and grow the types of cells needed. If Mesoblast waits for the trial to halt and approval before starting increased production it will take that much longer to be able to provide the cells. That is one very likely reason Mesoblast decided the money was needed, yesterday.