Top Tweets for #tofersenadcom
Thought for the week:
The reasonably good specific understanding of SOD1 ALS natural history played a big role in the #tofersenadcom .
We need such understanding of the natural history of all kinds of ALS.
We need a come-one, come-all natural history study for ALS. Now.
Which do you think provides a more accurate endpoint for FDA approval in #ALS? A 2nd grade, 12 question multiple choice test or a biological test that predicts progression? #tofersenadcom #NurOwn #EndALS #biomarkers
The FDA did a boo-boo on #tofersenadcom . 1) I believe Dr Romero was a sub for @MeritCudkowicz . If he had to recuse for the pivotal question why was he on the panel? He Was a sure yes as any als expert clinician would be!
Dear @US_FDA & @FDACDERDirector
Powerful AdCom yday w #patientreportedoutcomes like @sairysays
People w #ALS still doing #Peloton workout?
#TofersenWorks
We hope you follow 9-0 recommendation of AdCom for #acceleratedapproval of #tofersen based on #NfL
#tofersenadcom
#SOD1
Yesterday was a roller coaster day - alternating between exhilarating and frustrating testimony and voting. Based on the unmet need as well as the data, both our written comments and oral testimony support the urgent approval of tofersen for SOD1 #ALS. #tofersenadcom
We are grateful to the FDA Advisory Committee for reviewing the evidence, listening to the #ALS community and voting to recommend accelerated approval of tofersen for treatment of SOD1-ALS. Read our full statement: https://t.co/5WDbLRl0BT
Mom's story again in light of yesterday's #Tofersenadcom with @biogen. We deserve treatment now. #ALS #SOD1 @End_The_Legacy
https://t.co/mr84VfltGF via @business
And in the mixed messaging dept… #tofersenadcom
I wonder if deep down inside the FDA would like a do-over on the questions it asked of the #tofersenadcom yesterday. No do-overs in ALS Land.
In #Tofersenadcom, @FDACDER called reductions in #Neurofilament "convincing"
"#NfL is bad for neurons & is tied with neuronal death. So if it’s lower, then neuronal death should be lower,”
~ Dr. David Weisman
#acceleratedapproval decision by Apr 25
https://t.co/plS13cvVoM
Thankful Lincoln read me The Foot Book before bed. His little voice is everything. Reminds me what we fight for. #EndALS #SOD1 #Tofersen #tofersenadcom
@End_The_Legacy I will be anxiously awaiting the official vote. I am so incredibly proud of @End_The_Legacy, those who presented today and the entire #ALS community that stood with us. Today was a win for us all! Let’s #EndALS #tofersen #tofersenadcom
Correction - we are not merely pleased we are THRILLED the committee unanimously endorsed Accelerated Approval for #tofersen at the #tofersenadcom ! A new treatment is coming for this beleaguered community!
I spoke today at #tofersenadcom on behalf of 2 families... one was the Andrews family for Rebecca's boys Ethan & John. Born one year apart & died one year apart of #SOD1 #ALS
They were just 29 & 30 yrs old.
They deserved #Tofersen.
We'll never forget @BridgetRebecca4
@alsassociation @US_FDA Clear and compelling?
I heard consensus that the biomarker was good enough for accelerated approval for SOD1 ALS.
I didn't hear any agreement on how a confirmatory study would work. That's a huge issue for FDA using AA right now.
#tofersenadcom
Agreed. I was left mildly confused and guardedly optimistic. When you lost the genetic lottery you learn not to trust the odds. #tofersenadcom
We are pleased logic won out with the adcom endorsement of NFL and their clear eyed acknowledgment that the benefits of Tofersen outweigh the risks for SoD1 patients, disappointed and frankly confused those two yes’s turned to a no in the efficacy question!
🧵on today's FDA Advisory Committee votes and outcomes. Nothing is easy in #ALS land. #EndALS #tofersen #tofersenADCom @biogen $BIIB
The tofersen AdComm voted 9-0 that there was sufficient evidence that a reduction in plasma NfL concentration is reasonably likely to predict clinical benefit of tofersen for treatment of patients with SOD1-ALS.
However, they AdComm voted 3 yes and 5 no on the question of...
Whew. That was a long day! One more volunteer activity to go. The fight against #ALS does not stop. #EndALS #tofersenadcom
Benefits outweigh the risk but the drug did not prove efficacy. Someone needs to give these adcom voters a lesson in logical consistency! #tofersenadcom
So I think I just heard an #tofersenadcom say that the biomarker was good enough for accelerated approval and that the trial evidence was not good enough for regular approval.
So here we are.
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