The Great Pharmaust FDA ODD Approval Sweepstake, page-138

"The FDA don't move for anyone "

Could be true maybe not. Relyvrio was initially rejected by the FDA then approved because of public pressure, they moved there. PAA's application has not been rejected far from it. The FDA have the compelling top line results, don't think there would be much to discus there ie all patients alive and doing well, a 1000 to 1 chance

https://alsnewstoday.com/news/vet-drug-monepantel-slows-als-mnd-disease-progression-trial/
With articles like this I recon the ALS community in the USA would coming aware of hopefully a 1 in 1000 treatment. The FDA would be feeling the pressure as there is no other real treatment.
What sets MND/ALS apart is the lack of time suffers have....DAAC