Important piece by
@PeterPitts
NurOwn belongs in this conversation too.
As Pitts wrote, “every delayed approval has a human cost.” For ALS, that cost is brutally literal: roughly 5,000 Americans are diagnosed each year, and most patients die within 2–5 years. (CDC)
While the NurOwn Citizen Petition sits unresolved, nearly 5,000 people with ALS have died waiting.
This is a 100% fatal disease. Patients do not have the luxury of perfect timelines, perfect data, endless process, or regulatory hesitation disguised as rigor.
If a treatment shows signs of extending life and preserving function in ALS, the FDA should be leaning into the urgency to approve, not delay.
@houmanhemmati @FDA_KyleD @SecKennedy @DrPatrick @aVoice4ALS 👇