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Ok, I now understand what you are asking! I am familiar with oncology approvals rather than other therapeutic areas, so Yes, one can add a second indication as a full/regular approval (i.e. no confirmatory trials required for this specific new 2nd indication say for example, 2nd indication is supported ...

I'd recommend (logically) for NCE/NBE after dose escalation and possibly once you reach MTD or other appropriate criteria to determine recommended phase 2 dose. This stage of development is still considered early development phase! Your statement "There's even the risk that studies can be put on clinical ...

Yes, it is possible in the US! I don't see why not as long as they are two different indications or populations studied! For example in oncology, gastrointestinal stromal tumor after disease progression on or intolerance to approved therapy can be via full approval but then an indication for RCC via ...

Yes! Priority review is determined after you submit the application, 60 days from receipt date by the FDA. ------------------------------ GRSAOnline ------------------------------

Agree with Peter and the Anon above who stated parenteral NDA is not a biologic/BLA. Type 1 DMF is not required by the FDA. ------------------------------ GRSAOnline ------------------------------