Stories like this would be a game changer for this new company. I genuinely hope they go for it. In a way, it's surprising that there isn't a charity dedicated to this type of effort for drugs considered safe.
From my very limited understanding of the regulations, a company would have to spend the million+ dollars it costs to get FDA approval, but then wouldn’t be able to recoup that cost by selling the drug exclusively because the patent has long since expired. The US has this class of drugs that just never got approved and no drug company will ever pay to get approved, even if they are commonplace in other nations.
[0] https://en.m.wikipedia.org/wiki/Piracetam
[1] https://medcraveonline.com/JPNC/peac-prolonged-expiratory-ap...
[0] https://www.fda.gov/patients/learn-about-expanded-access-and...
A few times we’ve missed a day and it’s not a fun experience. Something as innocuous as a diaper change can mean giving her getting upset, turning blue, pulling out the a bag and mask, and giving her oxygen and hoping she’ll come to. Then she’ll sleep for hours. If it’s especially bad, like it was before, she’ll forget words which is super scary.