Friday, November 06, 2015 6:05:52 AM
Peer review publications have zero influence on the FDA clinical trial decisions. Such information made public in these Journals will have been under review months earlier by the FDA as submitted to them by the Pharma. The FDA has its own review committees that determine these clinical trial statistics for healing and/or life extensions results. The FDA, and only the FDA, determines then on the NDA decision.
$ELTP has chosen to forego such peer review journal publications in order to PR directly and immediately with their shareholders. The statistics have been thoroughly reviewed under strict FDA guidelines before PR to the shareholders.
Chief Executive Nasrat Hakim release of such statistics is of the highest review and the same data that the FDA will review for the NDA decision of ELI-200.
Recent ELTP News
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