Replies to post #174661 on Biotech Values

[DewDiligence]

Re: New NCE rule for FDCs

What if elvitegravir was already approved and the only new drug substance in Stribild was cobicistat - would that qualify?

Yes, IMO, if Stribild itself weren’t already approved. The FDA is not granting retroactive NCE status for FDCs that qualify under the new rule.