Itescue told The Sydney Morning Herald that he expected the data request to set back its planned launch “somewhere in the order of three to five months” excerpt from an article dated 2/10/2020
https://www.biospace.com/article/fda-rejects-mesoblast-s-remestemcel-l-for-graft-versus-host-disease/
another example of SI’s track record on bringing projects to fruition
in MSB land:
discussions with FDA are always “productive”
deal are always “imminent” or in “advanced stages”
results are always “promising”
in the real world:
no FDA approvals
partners walk away from deals
trial after trial misses primary end points
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