How do you see MNTA driving the process [for substitutible biologics] other than lobbying?
1) By submitting an ABLA -g-
2) By indirectly helping the FDA to created guidance clarifications and responses to Citizen's Petitions.
After further thought maybe 18 months (after initial regulations are signed off by FDA) is too aggressive for the above - maybe 24-30 months is more realistic.
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