@PledgeVery few of us put SI on a pedestal, but your constant detesting of him gets a bit repetitive for all. He also gave very honest (slim) odds in 2012 on MSB's success likelihood. They are still out there at phase 3 stage, with a very credible chance on more than one application, very much against his own given odds.
The Board and Silviu have inarguably made strategic errors and not minimised the risk in regulatory pathways execution in places, but they are at last more strictly following the still vague and apparently moving directives of the FDA (as they will have claimed they were to a degree before in GvHD). It would be snatching defeat from the possible jaws of victory to boot SI now - we are stuck with him unless you can offer a very credible candidate and convince shareholders to do an EGM, rather than just bagging him so regularly.
The FDA has approved the manufacturing process, and confirmed “that changes implemented appear to improve assay performance relative to the original version of the assay used in the pediatric Phase 3 trial.” and we now are on the verge of the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) trial, which may even have an outside chance of being a confirmatory trial:
"We have generated significant new potency and characterization data for our lead product Ryoncil® (remestemcel-L) for children with acute GVHD, as requested by FDA, and will submit these data
ahead of our planned meeting with FDA this quarter.”
"Mesoblast will provide the Phase 3 trial protocol to FDA
ahead of the upcoming meeting this quarter." (my embolden and underline)
SI will be pushing to make this a confirmatory trial from past comments. There are of course possibilities of an AA in Revescor with the recent Rare Pediatric Disease Designation. If he is successful in either, me thinks all will be forgiven:
“Given the impressive enlargement of the left chamber we have seen in these children treated with REVASCOR in the randomized controlled trial and the increased ability to successfully accomplish life-saving surgery, we plan to meet with FDA to discuss the potential for this trial to support accelerated approval in this indication.”
(20min delay)