"I’m thinking we get an answer on Friday US time as to whether the evidence is enough to be deemed a resubmission. Plus whether it is Class 1 or Class 2.
My opinion - don’t give a stuff what the naysayers are on about.
Friday - end of 14 day turnaround as stated by CBER"
You've changed your thinking since the 3rd of October in your post 63998141 then.
CBER has not changed the relevant SOPP 8405.1 or the definition of a BLA resubmission ("that purports to answer all the deficiencies that need to be addressed by the applicant before approval as set forth in the CR letter") and MSB haven't changed or updated their announcement where a major milestone was mentioned but no such purporting of answering all deficiencies was made.
Pity there isn't a practical way to have a side bet with you.
MSB Price at posting:
$1.02 Sentiment: None Disclosure: Not Held
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