Happy Monday everyone, I have two questions which i am trying to dig so any help appreciated:
1) Why there was no inspection booked last time by FDA - have they made up their mind from the start that they will not approve. Then why they waited till the last day to hand over CRL.
2) Last BLA submission FDA raised the issue and asked ODAC to vote.. was it part of 74 day letter
Any help appreciated. Thanks
banter and General Discussion, page-6596
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