Ann: Trading Halt, page-178

FDA's OTAT agreed to CLBP trials primary endpoints on 16th December 2021 and MSB has not started the trial yet (18 months since then).

I think there are couple of reasons: Most obvious to me is the funds. They have two options, going for partnership and giving away more than they would if they were in stronger position. Or wait until they get into stronger position, financially as well as regulatory. Financially as to have better market cap at the time and regulatory as to have more promising outlook with FDA or even a single drug approved (first one matters the most ofcourse).

If you remember the article in AFR doubting MSB to be a going concern. (link below).
https://www.***.com/markets/equity-markets/mesoblast-takes-shareholders-to-last-chance-saloon-20210301-p576mx
"Mesoblast’s half-year report contains some classic lessons for investors in the high-risk biotech space, after its auditor PwC warned of material uncertainty over the $1.33 billion biotech’s ability to continue as a going concern."

They had to cut the costs drastically and slow down now to be able to speed up later.

Others are as you have mentioned already, to get as clear runway as possible before taking off.

I think...this one hurdle of Ryoncil BLA clears a lot of things as it clarifies Clinical and Potency Assyas and manufacturing capacity as well as firms' ability to raise funds when needed (it's common for BioTechs to burn a Billion dollars before getting commercial).

I think even CHF meeting with FDA would be better with this clear(er) runway as it gives them more confidence.

Just my 2 cents.

I think we are close.

DYOR