Thanks @greenshoots11, well said. I made a similar point the other day that I feel this is really about the first approval of Stem Cells. I wasn't the first to make that point on this forum, but I am glad to see that Tanushree Jain drew the same conclusion. She was the first to ask questions on the webcast, which I listened to live, and she sounded as shocked as I felt by the CRL.
I thought at the time that it was curious of MSB to include an update of the COVID-19 trial in their announcement about the CRL, because 1. technically it is unrelated to the CRL and 2. it is unlike them to update the market with no new information, (other than the timing perhaps?) So I thought it was probably included to soften the blow.
During his webcast introduction, SI stated, "also announced today is that we are set for the second interim analyses of the phase 3 trial of Remestemcel-l in COVID 19 ARDS patients...we expect to release the results of that in early November."
But then he said something which I felt was a little off-script, or at least a big hint:
"The body of evidence around the use of Remestemcell-l in inflammatory indications of high mortality risk continues to build."
So I increasingly feel this comes down to ARDS now. If the FDA can sign off on that gold standard trial first, then hopefully other approvals will swiftly follow.
Anything is possible in the US over the next three months, but one thing is certain. They are going into a COVID winter whether they like it or not. Some credible forecasts suggest mortality could double by the end of the year, so the results of MSB's COVID-19 trial will be presenting just when they need this life-saving treatment most.
(20min delay)