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Thursday, December 02, 2021 9:03:36 AM
I am not a rare unicorn by FDA definition but I am uncommon.
I have done step 1 and it was done for others here. I trust step 2 and 3 to professionals more trained, experienced, and who have actually spoken with FDA about issues like this. I do not need to do the research because lack of evidence is not evidence. I have run a coming soon campaign at congress and taken part in others. As I said, small companies can make big mistakes. The question is whether or not that is true of LP and LG. It sounds like you believe that a company in the midst of a regulatory process in the US has free will to do and say what they please…they do not. It also sounds as though you remain stuck on the second step of a campaign that began two months prior.
A question for you. The excuse for taking almost 2 years to lock the database is SAP and IDH. The excuse for delaying TLD for over a year is the need for third party, expert validation of the science. What is the excuse for not beginning a regulatory process by mid-summer? Would something that anyone can come up with involve FDA negotiation which means process and gets antennas up?
The purpose of legal disclaimers is protection but it is also a demonstration of competence. As are my other posts to you.
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