Just had a thought.
Has the new data been submitted as an
IND file to avoid a Class 2 classification on
a full resubmission?
Speeds up the process by three months .
This means the first quarter projection of
market approval is achievable.
Any resubmission with extensive new data
cops a Class 2 and 6 month wait.
Perhaps all the doctors involved have arranged for
a bypass..
Reg
Just had a thought. Has the new data been submitted as an IND...
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