Everyone seems to be missing the point here. In 2014 the FDA said it was not a problem. PERIOD
Then in 2016 of April when the new guidelines came out...(Which was 4 months after FDA accepted the application from elite) the guidance changed leaving Elite caught out in no man's land.
No one wants to acknowledge that the guidelines FDA said was acceptable in 2014 changed in 2016 which was 3 months prior to PDUFA date.
So what does everyone do.....bash the CEO the company and now calling the very drug that every LONG once hailed as the flagship drug....now call it zombie sequestox.
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