Sunday, November 21, 2021 12:55:08 AM
You can have name and general mechanism, you can have the words ‘coming soon’ and name only or you can have I believe company name only and disease state, possibly the words coming soon there as well. No one does the last option…first or second are the two seen. Generally, you only do the second if it is truly ‘soon’ like within weeks. If you kick it off earlier, you do the other.
From first draft label to approval is generally about 3 months.
IMO CassieW is spot on here… you are now left with only two options 1) pending FDA approval, or 2) fraud.
I always said FDA would come first if they are not doing Orbis…it seems I was right.
BTW if the booth design said a disease state anywhere on it, that is why there is no booth this year. You cannot do both. FDA does come down hard on coming soon violations.
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