Biotech Values

[DewDiligence]

Gilead anticipates submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the fixed-dose combination following validation of the TMC278 NDA.

The word validation is needlessly obfuscating, IMO. GILD is saying that it will submit the NDA for the TMC278+Truvada combo pill when the FDA accepts JNJ’s TMC278 NDA for review, which should be about two months after JNJ submits the TMC278 NDA.