Quote: "They have meetings with FDA where they presenting their arguments , and protocol is negotiated .
"Make a great points , put all in a written form , and if you do have a good arguments let’s see if they refuse on the paper."
You seem to believe that Dr. J and other CYDY management are 1. too stupid to recognize the seriousness of ICI issue and 2. too incompetent to deal with it in a manner most beneficial to the CYDY. I disagree! I think they are certainly bright enough to recognize the issue, its seriousness, and competent enough to make all the appropriate suggestions/recommendations, and forceful arguments. It appears to me they have been turned down (I would guess repeatedly) by the governing FDA. Likely because of the FDA's ignorance of LL's MOA and bureaucratic protocol. I also believe CYDY has documented the same in consultation with legal counsel (Just guessing on my part having worked from a corporate perspective with a number of very large bureaucracies for over 25 years).
Quote: "I will like to see written now that our company asked FDA and they wrote NO ."
I don't think CYDY gives a shit what you want to see as opposed to acting in the best interest of the company and maintaining a positive relationship with the FDA. Again, just a guess on my part.
"Make a great points , put all in a written form , and if you do have a good arguments let’s see if they refuse on the paper."
You seem to believe that Dr. J and other CYDY management are 1. too stupid to recognize the seriousness of ICI issue and 2. too incompetent to deal with it in a manner most beneficial to the CYDY. I disagree! I think they are certainly bright enough to recognize the issue, its seriousness, and competent enough to make all the appropriate suggestions/recommendations, and forceful arguments. It appears to me they have been turned down (I would guess repeatedly) by the governing FDA. Likely because of the FDA's ignorance of LL's MOA and bureaucratic protocol. I also believe CYDY has documented the same in consultation with legal counsel (Just guessing on my part having worked from a corporate perspective with a number of very large bureaucracies for over 25 years).
Quote: "I will like to see written now that our company asked FDA and they wrote NO ."
I don't think CYDY gives a shit what you want to see as opposed to acting in the best interest of the company and maintaining a positive relationship with the FDA. Again, just a guess on my part.
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