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Re: None

Friday, 10/18/2013 11:11:30 PM

Friday, October 18, 2013 11:11:30 PM

Post# of 427816
SPAs are binding unless public health concerns arise. If you read section of FDA document introducing the part on not following a SPA:
"The agency will not alter its perspective . . . unless public health concerns unrecognized at the time of protocol assessment. . . The special protocol assessment should be considered binding"

Also that 30-day meeting needs to be requested by Amarin.
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