Morning all
I was just had another read of MSB's announcement from the 29th July and have copied a paragraph below:
Recently published guidance to industry by the U.S. Food and Drug Administration (FDA)3 has
recommended demonstration of mortality benefit for at least 60 days in critically ill patients. Mesoblast
will be meeting shortly with the FDA to discuss the durable mortality reduction seen in patients under
65 years old who received remestemcel-L in this randomized controlled trial, and the regulatory
pathway for remestemcel-L in this patient population.
Has anyone read the CBER 2021-2025 Strategic Guidance that was released in February, makes for a very good reading, this is the published guidance referenced above (FDA)3, link below if anyone would like to read it:
https://www.fda.gov/media/81152/download
snippet of the first objective taken below:
Cell Therapy News/Articles, page-10689
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