Re: Brand or FoB?
>Although a regulatory pathway requiring an abbreviated application is still a possibility, I think that for many Fob's phase III shaped studies would likely be needed to demonstrate therapeutic equivalence to the reference product.<
This does not make economic sense, IMO.
If regulators require a company to run a full-fledged phase-3 program and preclude the company from relying in part on the clinical data for a reference drug, why would the company bother to do the additional work of demonstrating therapeutic equivalence? In such as case, it will be simpler to just submit a standard BLA, which is what MRK says it plans to do.
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