After letting this announcement sink in, it's still unclear to me.
Yes, we've moved forward with this announcement - but, not as much as I have expected.
I would have preferred to see clear statements, something like...
The next step for Ryoncil is BLA re-submission which we'll commence right away and will be submitted to the FDA in Q1 2022.
But, we didn't get that - so it suggests to me that this is part of the OTAT process and another meeting is due to go over the actual data itself - so unfortunately more waiting. Looking at the SP, the market has interpret as such
Still - we've got an announcement before the end-of the year 2021 and have ended with a Green Friday for the year.
Small wins - but, I'll take them atm
GL MSB'ers and stay strong
Have a great break and enjoy your NY festivities
Ann: Update on FDA Meeting for Remestemcel-L in Paediatric GvHD, page-104
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