Agree OP- I would even say 3 months is possible.
No Adcom to be held - already approved efficacy with a 9-1 vote
No 483- that is spectacular- Lonza must have blown their socks off. - manufacturing processes approved
All Clinical data to do with phase III trial already reviewed - zero safety concerns.
All the above is at least three months work.
Add in the zeroing in on specific requirements/issues/problems raised by the second CRL , decreases the timeline even further
Three months- even less , to go- to complete the PDUFA process.
Sweet baby Jesus- you would want to be holding for an approval-
No FOMO for moi- locked and loaded
Good luck to all the beautiful people
Reg
Now lets close on a high, last acceptance day - turnover 13,481,022 shares- already over 20,000,000 today xxxxxxxxxxxxxxxxxxxxxxxxxx
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