MSB - Most exciting 6 months, page-619

Thanks @shax786 - I would defer to the more scientific posters like @otherperspective and @LeftYahoo on their opinions

There are risks, but I'd look at the following to gain a level of confidence:

1. 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
2. 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
3. Rem-L is safe and effective; as demonstrated in ODAC and Japan
4. EAP success
5. NIH willing to back Mesoblast (to the tune of US$50m or so)
6. All these hospitals signing up
7. 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