agreed.
Whilst mostly distracted with all things regarding aGVHD BLA resubmission, I am mindful that news re the pre-BLA meeting with the FDA could now also drop at any stage.
From March 11 Announcement:
"In feedback provided to Mesoblast regarding potential pathways to licensure for rexlemestrocel-L, FDA’s comments indicated that the presented results may support a reasonable likelihood of clinical benefit of MPCs against mortality in LVAD patients, consistent with the criteria for accelerated approval.
Mesoblast intends to request a pre-BLA meeting with FDA to discuss data presentation, timing and FDA expectations for an accelerated approval filing in end-stage ischemic HFrEF patients with LVAD implantation. "
GLTAH
V
agreed. Whilst mostly distracted with all things regarding aGVHD...
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