" then what changed their minds and on what points of consideration should be the questions" -
I have asked this of you before- it is a fact that something has changed otherwise the submission would not be proceeding. The only public acknowledgment has been an acceptance of improvement in the potency assay.
I think you cop the heat for arguing that what caused the second BLA, is still the status quo.
The company thinks otherwise,
the TYPE A thrashes things out- the TYPE C was for feedback on data , no more meetings
- resubmit
not long to wait now
Reg
banter and General Discussion, page-10253
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