MSB Trading - Aug 2020 on, page-1097

"The FDA approval this week is now very unlikely..."

Very unlikely? What's the basis for that?
Apart from the fact that no one was expecting a decision from the FDA this week no matter what it thought of the application.
The FDA are doing what they are paid to do -- they are not going to rubber stamp this application or wave it through without asking tough questions.
So what if they are questioning the fact that the phase 3 trial was a single arm study? Or pointing out that the mechanism of action of MSCs is not yet "clearly established". Or that the old trials didn't meet their endpoints? These are all known facts. Nothing new there. Do you think these are points that will have taken the company by surprise? Or that the FDA wasn't aware of these things when they granted priority review?
And what did you expect the FDA to say?
"You know we prefer to have two radomised trials before giving out an approval, but no worries, we are not going to ask any questions about that -- here's your approval, now be on your way."
I think many people convinced themselves that this meeting would be little more than a formality. Well, it's not, but that doesn't mean approval is unlikely.
As for the selloff, it's a massive overraction by people with unrealisic expectations who somehow thought that the obvious questions would not be asked. This has energised the short term & momentum players. The usual well timed but ignorant newspaper pieces have also played their part.
I still believe MSB will have the answers to get through this even if it is on the basis that they have to do a post marketing (phase 4) study.
GLTHA