Love It.
I'm having some serious regulatory issues at work , bio-security, customs & the like.
Sometimes you wonder if it is worth the effort.
But then you remember that this difficulty, by it's very nature, is a large barrier for market entry for competitors.
One should actually rejoice in the difficulty, for once overcome, the product in question demands higher margins due to scarcity and lack of competition.
I see CardieX's FDA journey with regards regulatory authority for an at home CBP device the same way.
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