Figgs: I can't find the FDA letter responding to
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Posted On: 04/13/2022 7:14:03 AM
Figgs: I can't find the FDA letter responding to CYDY regarding the refusal to approve. I recall it was about seven pages detailing failures from Amarex to properly submit data, even after they were given detailed instructions (by FDA) on what to do to accomplish this. All this apparently occurred while CYDY was blind to the developments and was getting spoon-fed updates from Amarex with excuses on the delays. It was only when Nader demanded they file for approval with the available data that FDA responded to CYDY regarding the problems.
That's just my take looking back. I recall the FDA letter is destroys Amarex throughout and will be a dagger if this goes to court. I've not even considered what this has done to CYDY in terms of damages in bringing leronlimab to market but the latest 10q suggests the delays were a direct result of the CRO missteps.
One thing is for sure...we are going to find out sooner or later.
That's just my take looking back. I recall the FDA letter is destroys Amarex throughout and will be a dagger if this goes to court. I've not even considered what this has done to CYDY in terms of damages in bringing leronlimab to market but the latest 10q suggests the delays were a direct result of the CRO missteps.
One thing is for sure...we are going to find out sooner or later.
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