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Tuesday, October 17, 2017 11:07:36 AM
Who says the FDA warning letter is ever going to be lifted?
Nothing but BS speculation. I will go the latest statement from the company:
"Regarding the warning letter, what is the status of the warning letter? Nothing new, the FDA came into Elite. They conducted a full inspection that had several branch. They looked at the previous commitments we made from the previous inspection. They look at the warning letter commitments. They evaluate us for general GMP, and two, three approval inspections.
All these five resulted in [two item 483] [ph] that have nothing to do with warning letter. The inspectors that went through all the attributes of the warning letter, told us that we have met our commitments. We have responded. All the responses are with FDA, and we just await their final decision. I believe it will be favorable. Obviously, the fact that they did not write us up on anything, will tell you it's going to be favorable. But FDA sometimes moves a little slow."
https://seekingalpha.com/article/4098297-elite-pharmaceuticals-eltp-ceo-nasrat-hakim-q1-2018-results-earnings-call-transcript?part=single
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