viernes, 9 de agosto de 2019

So much for Amarin’s best-laid plans

The Readout
Damian Garde

So much for Amarin’s best-laid plans


Had Amarin gotten its way, this is how things would have worked: Summer would have quietly faded into fall, regulators would have stayed quiet, and approval for an expanded use of its heart drug Vascepa would have been secured by late September. Then, blockbuster sales.

But, nope. Yesterday, Amarin said the FDA has scheduled a Vascepa advisory committee meeting for Nov. 14. The drug’s approval deadline will be extended. Those pesky regulators have questions and possible concerns about the heart drug derived from fish oil. Amarin beach vacations: canceled.

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