Given that he started at Mesoblast in October, 201
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Posted On: 10/20/2020 11:36:24 PM
Re: Borel Fields #62461
Given that he started at Mesoblast in October, 2019 and they submitted the BLA for remestemcel-L on January 1, 2020, it seems a bit unfair to imply that he contributed to the CRL result, a very controversial result I must add. It is doubtful that he would be placed in control of the submission so early into his tenure, but of course I'm just speculating.
I would cast more blame on whoever designed the trial protocol. It appears the FDA was looking for a randomized, controlled trial.
I would cast more blame on whoever designed the trial protocol. It appears the FDA was looking for a randomized, controlled trial.
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