Seriously I predict that if Frequency fails it will either because of these five things in no order
1: Frequencies pattened gel fails to navigate the cochlea efficiently
2: Severe and profound hearing loss not being treated effectively even though Frequency knows it won't
3: Over populated hair cell regeneration in lower frequencies causing low frequency hearing distortion
4: The unavoidable but natural process observed in reptiles of high frequency stereocillia being longer when regenerated
5: Hidden hearing loss audiotory nerve and synapse damage still present appearing that hearing is still distorted
Seriously if the FDA's only job is to go out of there way to prevent breakthoughs, they have hearing aid lobbyist and TRT shills in their pockets. The method Frequency is using is natural unlike gene therapy or pluri potent stem cells. It works with the bodies native biology
In a nut shell it uses the progenitor cell code from the intestine to the the progenitor cells in the cochlea to divide and turn into new hair cells.
Basically I predict a sad ending where the FDA deems mild and moderate hearing loss not important and the during the trial they make a breakthrough on how to navigate the cochlea better but they aren't allowed to modify their method for another 10 years by starting another trial.
Year of cochlear hair cell generation
2033