@tuts
Yes I do agree there …. the last 3 months has probably been highly consultative and repetitive with the FDA back and forwards and probably very iterative in their approach in the BLA build to land on a final complete submission.
Also consultation with various internal and external non FDA parties was probably also required. As it needs to be right this time!
We can’t see all the fine detail that occurs behind the scenes unfortunately, we only see the binary …submitted or not submitted status…which is a simplistic view of the situation I am sure.
Realism and communication goes a long way though and great to at least see an update today so we can all readjust timelines.
@tutsYes I do agree there …. the last 3 months has probably been...
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