Thanks for that correction @Bazsa. I was thinking of the generic...

Thanks for that correction @Bazsa.

I was thinking of the generic post approval requirements after Accelerated Approval (AA) is granted being a Phase IV confirmatory trial to gain FULL approval. Yes you are correct that if a product also has Regenerative Medicine Advanced Therapy (RMAT) designation then there are additional methods to confirm the post-AA clinical benefit that may lead that to FULL approval that do not require a clinical trial (e.g. real world evidence). My bad, I forgot Rexlemestrocel for heart also had RMAT designation. This is great news for us if we receive AA post the upcoming meeting with the FDA. We can market the product for the AA indication granted (e.g. LVAD, ischaemics/diabetics) providing income and further real world data which may be used to satisfy the post-marketing AA requirements and be used in gaining FULL approval without the need for a further clinical trial .


https://www.fda.gov/media/120267/download