The letter is written in a style suggestive of some sort of knowledge of the info given to the FDA.
Surely if they had inside info / knowledge they would have waited and objected to the full BLA resubmission when this was undertaken in 2023 in a more complex manner? The 5th December 2022 letter would surely be deficient in arguments against what was actually submitted in 2023 including the 4 year survival data given they didn't know what the information was at that time in 2022 - only MSB would have back then ?
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-981
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