Of course they will receive placebo PLUS Standard Of Care (SOC).
Patients will also receive SOC.
There is no FDA approved product at present.
As such, your previous post is unnecessary.
It was however necessary to point out that there is no RISK receiving SOC in the absence of an approved product.
If it was simply a misunderstanding of placebo only vs. placebo and SOC, I'm sure you can go back to when this argument started and either claim victory or otherwise pretend that it never happened. Either way, it makes no difference and is just as unnecessary.
But for arguments sake, lets say there is an approved product, then the bar is higher of course. If CYP-001 does not achieve better results than that approved product, it should and will not be used. Every patient should receive the best product available. Full stop. Regardless of who provides and manufactures it.
I see however a possibility that there is more than one product given the different subpopulation data. It could be, that one works for one subpopulation but maybe another for a different subpopulation.
What I am therefore interested in is the Orphan Drug market exclusivity and how that comes into play if remestemcel-L gets approved:
https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/clinical-superiority-findingsI have mentioned here that I don't believe that Orphan Drug's exclusivity can be limited to children:
https://hotcopper.com.au/threads/mst-access-values-cyp-at-2-76.6437681/page-20?post_id=57811063As such, it will likely come down to "clinically superior" and "same drug" and right back to my point that if CYP-001 is not the best product (in a subpopulation of/) for patients, it has no place:
https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/clinical-superiority-findings
(20min delay)