Hi all,
I have been a silent reader for the last 3 years but can't help myself to post this time.
I had a read of the summary provided by MSB on Remestemcel-L for aGVHD. One point stated that "within a maximum of 60 days after receipt of the complete application, Mesoblast will be informed by FDA of acceptance of the filing, and whether the BLA has received Priority Review under its existing Fast Track designation."
Does this mean that once the application is fully submitted, the FDA has two months to decide whether to allow the company to market Remestemcel-L?
Blackittie
MSB Trading - 2019, page-3799
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