Comment by xvector
Wow, the FDA is worse than useless. So much regulatory red tape. These guys had every single reasonable safeguard in place and the FDA kept putting requirement on top of requirement until literally no one would qualify for the study.
20-30 years later and humanity has had precisely zero benefit because of the FDA's simply absurd, technically impossible level of overcaution in this scenario.
It is incredible how much medical innovation is being held back because of these sort of politics. I hope the people that constantly cheer on more regulation or the FDA itself take a look at cases like this and hundreds of other similar cases where companies have simply given up on safe, promising approaches due to the regulatory red tape.
As somebody else pointed out above, the FDA is doing its job here. Putting random bacteria into peoples mouths could easily escape and contaminate other members of the population. With no guarantee of what this bacteria could potentially do in the wild, there is need to be cautious.