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Gilead's 2nd positive Phase III sets up early FDA submission for Quad

This article was originally published in Scrip

Executive Summary

Positive top-line results reported this week from a second Phase III study of Gilead Sciences' once-daily, fixed-dose, four-in-one HIV pill, known as Quad (emtricitabine, tenofovir disoproxil fumarate, evitegravir and cobicsta), has given the biotech giant the confidence it needed to move its timeline up for submitting a new drug application to the US FDA, which the company said will now occur before the end of this year rather than early next year.

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