This talk about the single arm trial not being adequate seems a complete ruse isn't it? The terms of the CRL would have been discussed in detail with the FDA in the subsequent Type A meeting. The FDA did not deny the Type A meeting. You can bet options around alternatives to another trial were discussed in that meeting. This is the benefit of this type of meeting is it not?
The BLA before the FDA is now stronger than before with additional real world data linking to long term survival, improved process controls we have
put in place to assure robust and consistent commercial product and a potency assay that predicts consistent survival outcomes. Meeting the SOPPS that would have been otherwise achieved through an additional trial. A trial that we know has moral and ethical issues due to the dire prognosis of the patients.
The FDA are all over this, this is not a game to them. The work has been done, good work it would seem from both sides (FDA and Mesoblast).
Cell Therapy News/Articles, page-16654
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