that’s a totally different indication, and they now have to meet with the FDA or at least submit an INd request referencing this outcome. This may be the last piece of info they need to file the IND, so they may not announce something until the IND is approved by the FDA, which from memory is automatic after 28 days post submission where the FDA doesn’t tell you otherwise.
a lot to look forward to in 2022, and seems Novartis leaving and the OTAT outcome were not related.
Anyway let the market join the dots, time to sit back and enjoy the rest of 2021. Take it easy all, and have a happy and safe new year.
goodluck
Ann: Update on FDA Meeting for Remestemcel-L in Paediatric GvHD, page-60
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