30 minutes of SI talking - enjoy:
EDISON - Open House - Global Healthcare 2021 MSB
Question @11:50 regarding 'needing to do more trials' - "In discussions with the FDA they will look at liscensing of a product on the basis of a single trial that was well conducted, that demonstrated CV benefit. They have also told us that mortality is the main outcome that they will look for to make a difference as to whether or not a product gets liscensure in this space." "Looking forward to those discussions with the agency."
He goes on to suggest that there is a possibility for the need of another trial however he then emphasises that the FDA are specifically looking for reduced mortality.
Cell Therapy News/Articles, page-8207
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