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ilovetech

08/12/22 9:03 PM

#386150 RE: Number sleven #386148

Sleven, I may have misunderstood the end game for the entire endeavor. But the Japanese are too smart frankly, to waste any time and money for something mediocre. Notice when the effort started. It wasn't too long, if not soon after Generics began pounding on the door, threatening not only Amrn's only product, but by extension, the single flagship product from the two oldest Japanese conglomerates and their decades of R&D. Companies of this caliber don't rest on their laurels, but rather keep innovating. That's where Generics are screwed. Moreover, these companies know one thing better than anyone, even Captain beer, their "customers." So the objective is always focused around the customer experience. They include price, effectiveness, and convenience. That's what Brands do.

ILT

ziploc_1

08/13/22 8:24 AM

#386154 RE: Number sleven #386148

I think it would now be worthwhile for Amarin to discuss with the FDA whether the studies by Mochida on MD2119 in Japan would sufficient for approval in the U.S....or whether additional studies would be required.


If the FDA indicates that more lab studies are necessary, Amarin could complete those with the help of Dr. Bhatt or Dr. Mason in a timely fashion.