i am clueless on fda protocols. the PR says tha
Post# of 148172
the PR says that CYDY is already in possession of the guidance.
and that the open-label expansion protocol will be submitted Monday.
so i guess there is some more paperwork that needs to be sorted.
but surely the fda is not going to think about it???
At any rate, I guess Montefiore and others cannot dose on Monday morning