I have stated before that I do not believe it will
Post# of 72440
That's been stated by someone WAY up the chain early on. Treatments would be expedited jumping over almost all the red tape if they're effective to be available to patients . It was stated that therapeutic treatments are different than new drugs trying to get approved. something along those lines. I remember seeing/hearing it during one of the many briefs early on, I just don't remember who said it.
With what we already have I'm thinking we just need the lab to verify it will be effective, possibly in more ways than one.