Yes. The FDA took 5 years from mL application to approval - and years to provide even minimal guidance on FoB. And the Momenta FoB isn't submitted yet.
Ok, so maybe 7 or 8 years worst-case scenario? I would hope too that the FDA has learned a bit having already gone through the process with mL and mC so one would hope there would be some efficiencies going forward on the FoB review process front.
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