If it appeared that the FDA was still not happy , the BLA could be withdrawn by SI
So what your suggesting is we are back to the drawing board if the FDA are still not happy after the company has had 3 goes at getting the potency assays right over about 5 years and we would just withdraw the BLA altogether ?
..... and what just keep supplying Remestemcel-L for free in the USA through the EAP for pediatrics while we wait 18 months for the adult GVHD trial to finish ?
Ann: FDA Grants Rare Pediatric Disease Designation for Revascor, page-358
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