Standard Ethical Review ProtocolI work in this industry, every drug, vaccine, medical device has to go through a standard ethical review. The ethical review guidelines must be met in order for FDA approval and trust me, they will be met.
As for the validation tests, like any study, you can not precisely predict a Stop on a study as it is reliant in this case to the number of Covid and non Covid patients that sign up to be a part of the study.
If you're a newbie or longtime holder, you are going to be exceptionally rewarded come next week!