Biotech Values

[DewDiligence]

FDA issues CRL for GILD’s Elvitegravir and Cobicstat standalone NDAs, which is surprising insofar as FDA already approved a combination—Stribild—that includes Elvitegravir and Cobicstat (as well as Truvada):

http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=1812215&highlight

As far as I know, this is the first time FDA has approved a combination product and then rejected one or more of the component drugs.

GILD shares are off less than 1%, reflecting investors’ opinion that whatever was wrong with the Elvitegravir and Cobicstat NDAs is easily fixable. Moreover, these drugs are not expected to be big-selling products on a standalone basis.