There are risks, but I'd look at the following to gain a level of confidence:
We did not make a new product, specifically for Covid-19. We've been working on Rem-L for a long time, it just happens that it also works well for Covid-19 ARDS
SI & team - would not risk damaging Mesoblast suite of products at the 11th hour to pivot for ARDS, if he didn't have sufficient data
Rem-L is safe and effective; as demonstrated in ODAC and Japan
EAP success
NIH willing to back Mesoblast (to the tune of US$50m or so)
All these hospitals signing up
The doctors, who have been interviewed have nothing but praises
...
However, there are two main risks for me with Covid-19 ARDS:
90 patients is not enough patients for DSMB to call off the trial due to overwhelming success. My concern here is not the % of success, but rather the 45 patients being treated on Rem-L is not enough. But, hey these are legit numbers that the FDA as agreed to - so who knows
Manufacturing - Mesoblast has been dealing with a niche market for aGVHD and are not ready for the massive massive lift in volume to deal with Covid-19 ARDS. The last CR was specifically raised to deal with this, but it all takes time. If the FDA had concerns with manufacturing for a niche aGVHD market, what concerns would they have with Covid-19 ARDS. So, with pressure from the WH some manufacturing news/ partnership is required here - FDA themselves need to step up and allow an accelerated path for 3D
MSB Price at posting:
$5.11 Sentiment: Buy Disclosure: Held
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