Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-416

Good question, Dimasq10. How do I come up with 99% for Covid-19 ARDS? Just off the top of my head (please DYOR and check):

1. There have been several small MSC ARDS trials/compassionate use authorisations done in several countries with similar stunningly successful results to MSB in Mt Sinai NY. For example, a recent Lancet peer review of Covid-19 patients treated with Adipose MSCs in Spain as a salvage therapy, when steroids and best available treatments failed, had similar results to MSB's Mount Sinai trial. There have been others including in China with similar results;
2. The current 300 person trial is being conducted as a public-private partnership in collaboration with CTSN under the US National Institute of Health. I would be very surprised if this US Government body would fund this trial to the tune of around US$50M if they were not convinced it was going to be successful.
3. We already know Rem-L works against multi-system inflammatory responses (aGVHD is this), and are therefore perfectly matched to what we now know happens in the body for those with severe ARDS. The fact MSC's seem to work well is no surprise;
4. MSB's Rem-L has an excellent safety history in over 1000 patients;
5. There is no other effective treatment for the serious cases of Covid-19 ARDS, where the current death rate is anywhere in the range of 40-80% for those ventilated.
6. I believe that the effectiveness bar for approval for Covid-19 ARDS treatments is lower than normal because there is a huge need for treatments that improve the results, not just the death rates. Governments are in urgent need for improved outcomes so that they can proceed to open up economies without the risk of such high death rates.
7. FDA has created a special emergency program for possible coronavirus therapies, the Coronavirus Treatment Acceleration Program (CTAP). The program uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful. It is rare to get such cooperation and urgency from FDA for new treatment approvals.

So yes, I am happy to use 99% for the likely success rate for my own investment purposes. Again though: Please DYOR