of course protocol is necessary but guess what else is FUNDING. They don't have it and they can't get it and there is a real big reason why. The science isn't strong enough. I see after the zika news hit florida xon got approval real quick for thier mosquito project. SNGX has all these rare disease indications that are badly needed and take forever to get protocol cleared not because of the FDA but because they drag thier own feet because if they didn't drag thier own feet they would go out of buisness to fast for thier liking.