this is from MSB announcement as part of the response to the CRL, 2/10
"". As there are currently no approved treatments
for this life-threatening condition in children under 12, Mesoblast will urgently request a Type A
meeting with the FDA, expected within 30 days, to discuss a potential accelerated approval with a
post-approval condition for an additional study.""
the wording can be seen as them meeting will be in 30 of the request or they have 30 days to respond and ask for the meeting
As I had taken this with other things i read, 30 days after request, FDA are bound to have that meeting, but also think i read MSB had 2 weeks to request the meeting in the first place (already past)... but while we haven''t got a confirmation on that question or whether they need to...as MSB have already said they would
this is from MSB announcement as part of the response to the...
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