Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-457

Oh dear- Whytee did not do so well today , bring on the doc.
Here you go doc - this is the fda commenting that presented results may be consistent with the criteria for accelerated approval.

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.

A negative comment from the FDA would probably read as the presented results are not consistent with the criteria for accelerated approval

But that didn't occur did it?

Just the factual positive statement, followed by a truckload of buying.

Hey doc- do you know the two major causes of death in the LVAD trial?

Reg