@StelloweThe 'coins' are always in the air. Unitl they're not....

@Stellowe


The 'coins' are always in the air. Unitl they're not. IMO FDA will agree to only whatever FDA actually does agree & whenever they get around to doing so. Unfortunately, that's the risk that all biotech operating in USA faces & has faced. It's only been worse for the last few years.

I agree that both MSB & FDA appear to be acting systematically, but I understood from CEO itescu's comments only that he was referring to FDA's past practice of granting marketing approvals based on endpoints consisting of components of 3-point MACE. We could all hope that practice will be a reliable indicator of FDA's future actions.

Dr Perin has confirmed a confirmatory trial will be required. The FDA has made clear in other publications that its interest will always be attracted by mortality or irreversible morbidity reductions, even where usual evidence of substantive efficacy isn't available yet.

So, the tension - as I see it - is between the arguments for/ against a possible limited marketing approval pathway conditional on a subsequent confirmatory trial, & arguments for/ against the speediest and minimally resourced prior confirmatory trial. Logically, even with all the best will in the world, MSB will have a number of challenges with an accelerated pathway for rexlemestrocel-l, not least being the delayed FDA licensing of its sister allogeneic product (remestemcel) for an indication. To its credit, MSB has not held out any particular prospect of timing or conditions of approval for Revascor.

It's hard to say which of the numerous rexlemestrocel 'coins' spinning up there may stop spinning when remestemcel-l is approved. For example, will there still be a need for CMC facilities inspection & updated release assay validation, I have a hunch there will be quite a few. And that they'll drop away quickly.

But for now, it's all eyes on remestemcel-l I think.