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Re: Scared_Trader post# 228332

Friday, 09/30/2016 2:25:19 AM

Friday, September 30, 2016 2:25:19 AM

Post# of 409517
I agreed completely. If you notice that over half of ADE reporting lack evidence ELTP provide any evaluation for the reporting.

I find this lack of SOP process in place is quite disappointing for a company filing 11 NDA.

It doesn't seem the resolution is in short term as FDA hasn't been satisfied with them since 2015 regarding ADE.
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