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Friday, August 05, 2016 3:40:00 PM
The reason I walked through all the headers with you for the complete response letter is because the silver lining in this whole disappointing issue is that this is a complete response letter and the FDA made no comment about Elite’s technology because it works and it’s solid. They made no comment on the human abuse liability studies because again they were solid and they work; or with the withdrawal study or the efficacy study – the Bunionectomy. This is great news for Elite’s ADT platform. There is no effect on Elite’s ER formulations because as I said their concern is that this is instant release and it’s used as needed so if you take it when you need it and you just ate a lot of fat then it affects you but for the ER they understand that a patient can plan to take it in the morning and then – before breakfast and before dinner.
Fear Uncertainty and Doubt FUD It Ain't Going To Work Here Anymore. Notice the lack of question mark.
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