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'Btripla' Gets Surprise RTF; Gilead Asked for More Data

By BioWorld Today Staff Reports


Wednesday, January 26, 2011
As proof that even experienced biotechs can hit unexpected regulatory roadblocks, Gilead Sciences Inc. received a stunning refuse-to-file (RTF) letter for its new drug application (NDA) seeking approval of HIV single-tablet regimen Truvada (emtricitabine/tenofovir disoproxil fumarate) plus Tibotec Pharmaceuticals Ltd.'s TMC278 (rilpivirine).

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