""Mesoblast held a Type A meeting with the FDA in November 2020 to discuss the review of the Biologics License Application for remestemcel-L. The current review team have not agreed to accelerated approval. However, there was consensus with the review team on the proposed optimization of potency assays and on use of biomarkers to demonstrate the product’s bioactivity in-vivo.
Mesoblast intends to meet with the FDA during Q1 2021 through a well-established process for continuing discussions on the potential for accelerated approval with a post-approval commitment to conduct an additional randomized controlled study in patients 12 years and older. "" (first quarter almost gone)
good overview of where we stand
https://www.globenewswire.com/news-release/2021/01/29/2166359/0/en/Mesoblast-Operational-and-Financial-Highlights-for-Quarter-Ended-December-31-2020.html
""Mesoblast held a Type A meeting with the FDA in November 2020...
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