Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-155

Hi @OP, As an RMAT product, Rexlemestrocel can clearly be given an accelerated approval as well, so long as either of the 2 conditions on p.9 below FDA guidance is satisfied.

https://www.fda.gov/media/120267/download#:~:text=Sponsors%20of%20regenerative%20medicine%20therapies%2C%20including%20products%20designated%20as%20RMATs,the%20primary%20evidence%20of%20effectiveness.

Condition 1 is meeting a surrogate end-point but since the current endpoint is 12-month pain reduction for a pain reduction trial, and in any case, the trial is not over a long period of time, this condition is unlikely to be much benefit. However, alternative condition for AA, being the use of multi-site data, is clearly something that the FDA can rely on to grant AA, and is something that is mentioned by CMO Dr. Rose’s comment in the recent commencement of CLBP trial recruitment announcement.