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Wednesday, December 01, 2021 9:28:53 PM
I agree with you that there was a change in their approach to the bags from previous bags and that the bag seems to fit into the safe harbor. I do not know the specifics in terms of whether there is a specific measure of “soon”, whether 6 months or what, but I believe you identified a very real question and seeming hint that is not intended to be a hint to investors, but is just an extremely subtle change under old FDA rules that are allowed to continue. And I do expect that “soon” likely would have a meaning in the interpretation of such rules, I just did not delve that far and the broad advice on the internet from many sources did not go into that detail.
That is a long way of saying, that after verifying myself, I changed my mind and believe you. When someone changes their mind after a clear back and forth with skepticism (and being clear that I am not one who deals with the FDA or it’s rules, so just giving an ordinary person’s opinion), I think it comes with a stronger sense of agreement. Though again, I can’t verify detail on timing, it is a real thing and the bags did seem to me to fall into the safe harbor. People as legally sophisticated as this team do not change such a bag to fit into such a safe harbor, in my opinion, without intention to utilize that safe harbor, and the previous bags I saw as examples further confirm it was a distinctly made change. I of course could be wrong and this is just my personal opinion. All IMHO.
Thanks MID! You gave me some highly specific information of which I was previously unaware. I knew they had to engage in any marketing, broadly defined, with great care. I did not know if this old safe harbor. Bags at a trade show, I would have thought are probably somewhat constrained, but had never thought to what degree. Your comments made me look into it and opened my eyes to just how narrow the rules are for these companies.
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