This may be naive of me, but I don’t think it’s as simple as politics or money, although there are certainly people who believe so and honestly I don’t blame them.

I think the FDA’s processes are genuinely disconnected from the reality of ALS.

Here is the bottom line on Nurown: it has halted, and even reversed the progress of ALS in some patients. That is an indisputable fact. And a miracle. A Jesus curing leprosy miracle.

Why is the FDA taking a hard stance? That disconnect between their processes and what ALS actually is. The ways to measure ALS are not an exact science, but the FDA treats the statistics coming from those measurements as one. Unfortunately, this hard stance means all the patients fighting for access are likely to die waiting, as many before them have.

It’s a hard topic to follow…I’ve seen many go from diagnosed, become active in supporting it to have a chance, and die before they will have a chance.

But if we have undeniable proof that Nurown works in some patients, and the science to say it works in 20%, why not give ALS patients the same chance that patients in other terminal diseases like cancer get? That is, quicker and more expanded access to drugs based on the fact that they have no real options.

And to more specifically answer your question, I think the company filed for approval for patients with all stages of ALS, and the FDA took a hard stance and said no. That’s just my theory. They met on the 11th to discuss the rejection, and my guess is the company will refile for the subgroup of patients they have the more concrete evidence for and then it will be approved.

The whole topic is a huge rabbit hole but if you want to know more please ask, I can pull some sources on the science part as well because it can be a little hard to find if you don’t know what you are looking for