Everyone needs to realize that the fda doesn’t just need to calculate or review our p value and then they are done.
We don’t have an approved drug so there is not an approved label.
The side effects need to be reviewed and agreed on.
The dosing needs to be finalized as well as the full scope of indications especially if their are sub populations that it worked well in.
If it was full approval (which I don’t expect) the Mfg would need to be thoroughly reviewed etc.
Look how long it has taken us to clean and review the data
It is so hard to be patient but please be realistic in your expectations or you will continue to be disappointed and frustrated.
IMO