[ATTACH] Although this statement above is a little ambiguous...

Although this statement above is a little ambiguous @LearningEachDay , mapping out a 'pivotal trial' could also incorporate the language / changes made to the Accelerated Approval process in 2022 ? In particular for example;


"The Food and Drug Amendments of 2022 grant the FDA explicit legal authority to require initiation of confirmatory studies prior to accelerated approval, setting of enrolment targets, and biannual (twice yearly) reporting of study progress. "


IMO the FDA could look at an AA pathway for either LVAD patients and / or ischemic diabetics (ie. a restricted cohort) ?


https://www.thelancet.com/journals/...mendments,yearly) reporting of study progress.

Reforms to accelerated approval of new medicines: long overdue





We will know once the FDA meeting for Rexlemestrocel-L has occurred and the market has been updated I guess


GLTAH