Saturday, April 16, 2022 8:58:46 AM
I knew I was putting myself out there with the tote bag, but when the ABTA full page advertisement was shown to me which has now been altered to a half page advertisement, my doubts were eliminated. I forget who dropped that bombshell in my lap, but thank you! There is no doubt, the ABTA branded, and hardly unbranded advertisements constitute premarket promotion in my opinion. But they followed the Name, disease state and MOA path, not the “coming soon” path.
My flaw was believing the very conservative viewpoint that 6 months rule applies to both. I now agree with the view that it only applies to the second pathway. Given what we now know about outstanding steps, path 2 was probably not even an option for them when they received a “green light.”
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