Not following this too closely, but if it's as fundamental as it...

Not following this too closely, but if it's as fundamental as it seems, then someone - you can decide who - is telling whoppers! When a company (ie, BLT) commence an FDA approved trial, the company in effect, "contracts", with an approved research team/body to conduct the trial to approved standards. Nothing to do with the company (ie, BLT) - they just get the bills to pay ;)

BLT have now given this Ph1 trial to the experts, the matter rests with them.