On November 17, 2020, a Type A meeting was held with the FDA to discuss the review of the BLA for remestemcel-L and a potential pathway for accelerated approval with a post-approval requirement to conduct an additional randomized controlled study in patients 12 years and older. At the current time it appears that the FDA review team will not agree to accelerated approval.
On November 17, 2020, a Type A meeting was held with the FDA to...
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