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DewDiligence

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DewDiligence

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Re: ciotera post# 174661

Sunday, 02/23/2014 11:56:34 AM

Sunday, February 23, 2014 11:56:34 AM

Post# of 257265
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.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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