Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-221

Hi @Blackkkkkkk,

(good thing I ate my Special K this morning)

Rolling review is available to Mesoblast for the CHF with LVAD BLA merely as a result of the RMAT designation. MSB doesn't need any additional Fast Track or Breakthrough designation from the FDA for rexlemestrocel in the ischemic CHF with LVAD indication, to be able to access rolling review for the BLA should it choose to do so, IMO.

That means a BLA accelerated approval for rexlemestrocel in the ischemic CHF with LVAD indication prior to 31 December 2024 is technically feasible, provided the Type B meeting is brought on quickly (if it hasn't already been requested - in which case, all good).

Hope this assists.

Cheers,
GLTAH