This is a SAVAGE announcement for first in class stem cell companies.
Take the Type B for Revascor end stage heart patients with an LVAD- two Phase lll trials data will be assessed with AI and probably the published Medical Journal data as well. The Accelerated Approval for those patients is likely- will they extend it to a wider group , possibly. For all we know that data could be being reviewed right now, ahead of the meeting.
Silviu was big on Investigator led trials for extending the label for Ryoncil into other inflammatory indications. If one of those " Investigators" qualifies for a voucher then their overall expense risk plummets. Time to market is swift with clear delineation of required approval parameters up front.
Archaic bureaucracy is dead and Mesoblast along with Gene therapies are in the front seats for the ride..
Happy Days
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