edjohnson
Active member
- Joined
- Nov 18, 2011
- Messages
- 48
- Reason
- PALS
- Diagnosis
- 10/2011
- Country
- US
- State
- nc
- City
- emerald isle
ALS TDI asks the following question:
If NP001 missed “statistical significance” why is it moving forward into a Phase III?
After you read the full article found in the link below I hope you will agree that since it is safe, it shows efficacy, and… " 1997 FDAMA measure.… For life-threatening diseases with unmet medical need, FDA can permit a sort of probational marketing approval".…the questions we should be asking are:
Why isn't it being made available now?
Why aren't they willing to work towards an EAP?
So, who has two hours per week to help obtain this treatment for PALS?
News: Neuraltus Pharmaceuticals Announces Phase 2 Clinical Results for NP001 in Patients with Amyotrophic Lateral Sclerosis (ALS) | ALS Therapy Development Institute
If NP001 missed “statistical significance” why is it moving forward into a Phase III?
After you read the full article found in the link below I hope you will agree that since it is safe, it shows efficacy, and… " 1997 FDAMA measure.… For life-threatening diseases with unmet medical need, FDA can permit a sort of probational marketing approval".…the questions we should be asking are:
Why isn't it being made available now?
Why aren't they willing to work towards an EAP?
So, who has two hours per week to help obtain this treatment for PALS?
News: Neuraltus Pharmaceuticals Announces Phase 2 Clinical Results for NP001 in Patients with Amyotrophic Lateral Sclerosis (ALS) | ALS Therapy Development Institute
