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Re: Whalatane post# 410094

Friday, 06/02/2023 1:44:30 PM

Friday, June 02, 2023 1:44:30 PM

Post# of 423948
“The AMNOG process requires the pharmaceutical company to submit data from at least two large independent randomized double-blind trials that demonstrate the efficacy and safety of the new drug. “

So how could Amarin even submit an application if they needed 2 studies?

Hilarious that it also says they can require additional studies OR a lower price!!!

Drug not so good but OK if we pay less for it.
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