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Monday, August 29, 2016 12:49:31 PM
"On July 18, I updated you on the FDAs response, that was only 3 weeks ago. In the past three weeks we ran a multitude of invitro experimentation that stimulated different ole, fatty, acidic, stomach and intestines. We have 3 proposals for the FDA to evaluate that would reduce or eliminate the Tmax delay. We can demonstrate this, we are at DE, but first we need FDA’s feedback and blessing.
We met Camargo and other consultants and are in process of preparing a package for the FDA shortly requesting a type A meeting. The process is a little complicated and it takes time. You first have to send a letter to the FDA requesting a meeting, once they grant a meeting and give you a date, you need to send them a package with all the testing and evidence that you need to present so they can review it before the meeting. Then we complete the work based on the FDA feedback’s and then we submit the new data and meet with them again to make sure that we delivered on the clinical trial that we said we’re to deliver on and they were successful. That’s when the whole thing gets concluded, at least this is the path forward.
I should have more details for you by the next conference call."
http://seekingalpha.com/article/3999933-elite-pharmaceuticals-eltp-ceo-nasrat-hakim-q1-2017-results-earnings-call-transcript?part=single
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