Replies to post #413885 on Amarin Corp Plc (AMRN)

[Whalatane]

RMB. well I cited the example of UNCY

Unicycive is seeking FDA approval of LDC via the 505(b)(2) regulatory pathway. As part of the clinical development program, two clinical studies were conducted in over 100 healthy volunteers. The first study was a dose-ranging Phase I study to determine safety and tolerability.
The second study was a randomized, open-label, two-way crossover bioequivalence study to establish pharmacodynamic bioequivalence between LDC and Fosrenol. Based on the topline results of the bioequivalence study, pharmacodynamic (PD) bioequivalence of lanthanum dioxycarbonate to Fosrenol was established.

Now this is a drug where one can make the argument of even greater medical need as compliance with the regular dosing of phosphate binders is abysmal .

Even so the FDA wants more data because even tho the adverse effects are the same as the original in severity ...there is more of them in the concentrated dose.
And this is based on over a years data in US patients .

So I doubt getting US approval for MND2119 is as easy as we would all like it to be .
JMO
Kiwi