From the quarterly update there are two things we should expect an announcement on in August:
Number 1- Regarding COVID ARDS, Mesoblast met with the FDA this week to determine the registration pathway for approval of remestemcel-L in this indication, with formal minutes expected in coming weeks.
IMO Number 2 - Novartis agreement based on the above.
On the 13th of August it will be a year since ODAC voted overwhelmingly for aGVHD To be approved, and we know what the FDA did from there.
The FDA has had some changes in personnel which could bode well for MSB and the science.
August may well be a catalyst for the paradigm shift we’ve all been waiting for, some longer than others and some not at all.
GLTAH
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