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Number sleven

10/21/21 11:46 AM

#357482 RE: CaptBeer #357479

Captain, I had the theory that the lack of a CVD disclaimer was the work of the FDA. I found evidence of it in one of the Hikma court fillings. All 4 of the ANDA's approved by the FDA omit the CVD disclaimer. Luckily for US, the FDA made me do it is not a valid legal defense.
Sleven,
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Number sleven

10/21/21 2:27 PM

#357490 RE: CaptBeer #357479

Captain, This absurd position that the FDA has taken is good for us. If Hikma could put the CVD disclaimer on their label they would. It wouldn't hurt sales and it would make it much more difficult for us to prove infringment.
Sleven,