The FDA. Hard a work as usual., page-4

Well the main catalyst at the moment is GVHD in children which has not approved treatment.

The FDA advisory voted 9 to 1 in favour of efficacy.

https://hotcopper.com.au/threads/ann-odac-votes-in-favor-of-remestemcel-l-for-gvhd.5556305/

It appears the FDA has accepted the latest BLA as a response to the 2020 CRL backed up by outstanding 4 year data.

https://hotcopper.com.au/threads/ann-fda-accepts-mesoblasts-bla-resubmission-for-remestemcel-l.7271425/

One of the main outstanding items is a manufacturing inspection which the FDA has since booked. This is a significant bullish signal as this want done in 2020, and the FDA wouldn't have wasted time on the process if not required.

https://hotcopper.com.au/threads/ann-fda-schedules-gvhd-pre-license-manufacturing-inspection.7295209/

Every discussion under the sun has taken place regarding every trial this company has done with the main criticism being from people who have spent multiple years on this forum and don't hold.

Questions like multiplicity not being accounted was addressed years ago and it was established the it was more of an issue when nit regards a greater number of treatment arms. I don't know why this is been repeated by non holders as it is not currently an issue.

The results for dream HF trial, which was the main concern for multiplicity, have since been published in the JACC.

https://www.jacc.org/doi/10.1016/j.jacc.2022.11.061

I am not sure why not sure why the OP decided to create a new thread for discussiond happening in other threads. The nature of his relationship to the company remains mysterious as the rare opinions shared only paint specific biased pictures.

People can judge for themselves whether there are "trial issues" that will affect near term catalysts.