doesn't bode well for the outcome of the OTAT meeting IMO, as I can't see Novartis dropping out if that was a successful meeting. Did OTAT ask MSB for additional data, resulting in further delays? That's now looking likely as a potential catalyst as to why now.
That being said, CHF and CLBP still in the picture and we know CHF is going for accelerated approval, so we still have shots on goal.
Not much to be said now to change sentiment though, it will be news driven like all things Mesoblast. Right now its not great. With COVID / ARDS are bit of a left field opportunity that came about due to this pandemic.. but the opportunity is still there to get that EUA, but funding will need to be found and timelines possibly pushed out depending on the outcome of that OTAT meeting.
Core assets are yet to be fully unpacked, and there lies the hope in the near term. Ryoncil, CHF and CLBP outcomes with the FDA ... we can only hope that these will be positive.
bad luck, but it's not over yet... if CHF is given accelerated approval.. that would be bigger news than Novartis signing on and running the ARDS trial, and will see sentiment change very quickly.
goodluck all
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