Replies to post #118597 on Biotech Values

[DewDiligence]

I wouldn't be surprised if a FDA decision on the Quad isn't held off until elvitegravir approval. Perhaps this was discussed in Q/A?

Only in passing. No one questioned the logic (or lack thereof) of the unorthodox sequencing.

[DewDiligence]

My feeling is that GILD's management is being presumptuous that the FDA will go along with the early [Quad] filing.

There’s no known problem with the Quad NDA so far, so evidently the FDA is ok with the NDA submission for a combination drug being made before the NDA submission for one of its constituents. However, I think this is a singular case, not an indication of a new FDA policy on combination drugs.