The debate over a new ALS drug harkens back to the Aduhelm controversy

https://www.washingtonpost.com/polit...m-controversy/

One fundamental problem with establishing whether new intervention is validly availed patients is proving both safety (little or no harmful effects or those treatable) and efficacy . . . to satisfy the requirements thousands of patients are usually needed, however, few patients are available with Amyotrophic Lateral Sclerosis so additional time needs develop. The 137 patients here may not be sufficient for establishing safety (phase II size . . . probably not large enough for adequate representation of the patient variance spectrum . . .

Step 3: Clinical Research
Step 3: Clinical Research | FDA

It takes ten to fifteen years at least for molecules for more typical diseases, so this one ought have more study . . . they say the safety data was apparently better than normal and therewith they can avail the product. Be aware one will need more conscientiousness when joining this ongoing trial.