You could have just linked the FDA page that you copy/pasted that from.
What cracks me up is that you seem to feel like you're knowledgeable on the subject because of some googling, but also seem to think that a team of scientists couldn't know what was expected from a trial by the FDA (even though you know what's expected because you can google).
Regardless of IIL consulting with the FDA or not they could have run the trial in accordance with FDA guidelines. The FDA doesn't keep its requirements hidden for some reason, only revealing them to people in person.
There's no reason to suspect that a team of people with millions of dollars on the line wouldn't bother to find out what was required from the trial.
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