2023 The Final Countdown, page-1368

I just think it could be fiscally responsible to secure a CLBP partnership deal outside of the Grunenthal licensed regions prior to the FDA decision and while some will say the company seems confident in the Remestemcel-L BLA resubmission, let's not forget they appeared 'confident' in 2020 although I do believe the situation is very different this time around


If the FDA for any reason delay or reject the BLA resubmission we will be negotiating / finalising a CLBP deal from a position of weakness and IMHO we will likely secure a weaker CLBP deal in that scenario should it present itself than if we signed off upon one now ? Just my 2 cents worth ....


..... in addition, Mesoblast stated on the 26th April that one reason for the CR proceeds would be that it was used to fund "initiation of patient enrolment in the confirmatory Phase 3 clinical trial of rexlemestrocel-L for chronic low back pain associated with degenerative disc disease" and almost 3 months later we haven't seen one patient enrolled so it begs the question of 'are we in fact waiting on the finalisation of the CLBP before we being recruitment ?'


I just think this needs to be looked at from every angle - best case scenario through to the worst case scenario and of course we don't want any further delays with the Rexlemstrocel-L phase 3 CLBP trial ....