Nikki J
Moderator
- Joined
- Mar 22, 2012
- Messages
- 16,384
- Reason
- PALS
- Diagnosis
- 04/2014
- Country
- US
- State
- MA
- City
- Boston
There should be a decision by the end of January. As the SOd1 community knows the tofersen trial failed to reach its primary endpoint in phase 3 which was a huge disappointment. However there were some positive findings in secondary endpoints and, I believe, even more importantly there are positive data coming from the OLE and EAP and indications that maybe the trial wasn’t long enough to demonstrate full effect. Anecdotally there are multiple reports of slowed and stopped progression and people outliving all of their previously affected relatives. I am hoping for an expecting powerful testimony at the ADCOMM. If you are SOD1 now is a vital time to get involved. Even if you don’t have a tofersen story you can support those who do. One place to make contact would be the IAMALS FALS team
FDA Accepts Biogen’s New Drug Application and Grants Priority Review of Tofersen for a Rare, Genetic Form of ALS | Biogen
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