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Re: dr_lowenstein post# 215726

Tuesday, 07/19/2016 3:41:23 PM

Tuesday, July 19, 2016 3:41:23 PM

Post# of 445433
So just so we're clear:

It was a labeling issue in 2014 when Elite ran the BE trial.
It was a labeling issue in 2015.
It was a labeling issue early and mid 2016 when Elite filed and discussed the data with the FDA, which then accepted the NDA as ready for review.
It metamorphosed into a safety issue the week of July 11th.

Mmmmmmk SOUNDS LEGIT. LOL!!!!!
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