[dredmorbius]

Final 'graph of the article:

[T]he patient advocacy groups took victory laps after Relyvrio was approved, and they were a big part of the pressure that made the FDA reverse its initial correct decision.

Motivated reasoning, whether by commercial interests, patient advocates, or any other group, is inimical with truth-finding.

Though on the grounds of potential benefit vs. known harm (which is assessed in Phase I/II trials) and partial knowledge, a provisional approval in the case of a treatment for a chronic, progressive, and fatal condition is reasonably defensible. The FDA's conditional approval was based on Phase III trials showing efficacy. The dice were rolled, though the gamble in this case proved fruitless.

[JPLeRouzic]

ALSA ALS association funded AMX0035 (previous name of Relyvrio) and by contract would get up to 3.3 $M if the drug was successful:

https://secure2.convio.net/alsa/site/SPageNavigator/blog_090...