edjohnson
Active member
- Joined
- Nov 18, 2011
- Messages
- 48
- Reason
- PALS
- Diagnosis
- 10/2011
- Country
- US
- State
- nc
- City
- emerald isle
Help accelerate stem cell treatments by signing this White House petition.… See link at bottom
Share on Facebook and social media.
I believe we also need to start one to have the FDA allow ALS trials to proceed without a placebo arm… There are thousands of placebo arm data points already in existence.… No need to sacrifice more patients.
And we might consider using the White House petition approach to ask the FDA to allow pharmaceutical companies to charge market price for expanded access programs. Allowing them to charge market price may eliminate one of the barriers that small companies see as preventing EAPs. Current regulations prohibit them from making any profit, they may only cover their manufacturing cost when providing their treatments to us.
https://petitions.whitehouse.gov/petition/stop-fda-over-reach-regulating-our-own-stem-cells/csQ6V3KK
Share on Facebook and social media.
I believe we also need to start one to have the FDA allow ALS trials to proceed without a placebo arm… There are thousands of placebo arm data points already in existence.… No need to sacrifice more patients.
And we might consider using the White House petition approach to ask the FDA to allow pharmaceutical companies to charge market price for expanded access programs. Allowing them to charge market price may eliminate one of the barriers that small companies see as preventing EAPs. Current regulations prohibit them from making any profit, they may only cover their manufacturing cost when providing their treatments to us.
https://petitions.whitehouse.gov/petition/stop-fda-over-reach-regulating-our-own-stem-cells/csQ6V3KK