Re: Precondition 2, could one argue that by virtue of having received a Breakthrough Therapy Designation, FDA has deemed that several psychedelics, including MDMA, "may be effective"? (Given that such designations are awarded to drugs where "preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s)".) It might also help with Precondition 3, no?
I will work 80-100 hour weeks as a paralegal to work for you and Shane if the need ever arises, this idea is brilliant, I have also concluded we need change to the entire system it’s not fixable and can do the research and communicate ideas well just throwing that out there
Very interesting ideas, as usual.
Re: Precondition 2, could one argue that by virtue of having received a Breakthrough Therapy Designation, FDA has deemed that several psychedelics, including MDMA, "may be effective"? (Given that such designations are awarded to drugs where "preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s)".) It might also help with Precondition 3, no?
Certainly.
I will work 80-100 hour weeks as a paralegal to work for you and Shane if the need ever arises, this idea is brilliant, I have also concluded we need change to the entire system it’s not fixable and can do the research and communicate ideas well just throwing that out there