Because it was up to the FDA and that some small studies may also be required and they wanted to make sure the FDA was 100% comfortable before they filed and then have the FDA ask for something else three months later complicating the situation.
Again, I am betting that Elite's stellar management and Camargo the leading 505B2 expert, have got this under control.
Trying to say that Elite did not meet some deadline would be a gross mis-characterization of the facts and numerous quotes and statements from conference calls. If you have some new data to present, let's hear it but saying the same thing over and over in the face of direct quotes from the company is not a winning argument.
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