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Re: hoffmann6383 post# 419942

Sunday, 11/21/2021 12:33:10 AM

Sunday, November 21, 2021 12:33:10 AM

Post# of 704163
You are only allowed to run a coming soon campaign within 6 months of approval and you have to have indication that you are on path to be approved from FDA…those are the rules as far as I have been told. I never looked into regulations myself, only believe what the attorneys have told me.

Usually they are shorter than six months because in my experience the attorneys won’t let you go forward without certainty which means draft label is already in play. You are never guaranteed that you will be approved, but once you get to draft label negotiations you know where you are headed, you just can’t say it publicly.

But you can run a ‘coming soon’ campaign. It has name and general mechanism. Bingo

It seems that they delivered at SNO after all.
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