There are a lot of nerves riding on this FDA approval, and it shows. It’s not a shoe in, and this Has been highlighted today. A monumental change for the company is imminent, but which way will it go. To have FDA approval for this, albeit small indication will value the company far greater than GVHD alone, as the green light has been given to the safety and process of cellular medicine. This opens up all the other indications when and if efficacy is shown.
on the other side of the equation, if the FDA is not happy despite the efficacy shown for GVHD, where does it leave the company and its pipeline? probably years away....
there will be a lot of people watching from sidelines on this one...
Ann: Update on Scheduled FDA Advisory Committee Meeting, page-72
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