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mrwrn2010

07/19/16 3:41 PM

#215728 RE: dr_lowenstein #215726

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!!!!!