Top Tweets for #FDACBER
.@DrMakaryFDA @FDACBER @SecKennedy: @pjgreen testified for #NUROWN, was denied by #FDACBER & #DiedWaiting
Delaying the July 3rd citizens petition & @BrainstormCell #BLA refile continues #FDA's history of apathy for the immense suffering & death of ALS patients
If Phil was YOUR family member, facing CERTAIN DEATH but blocked by the #FDA from a treatment that WORKED, what would YOU do?
@realDonaldTrump @RepGuthrie @RepLarryBucshon @michaelcburgess @RepGusBilirakis @RepBillJohnson @RepRichHudson @RepBuddyCarter @DrNealDunnFL2 @cathymcmorris @LeaderJohnThune @RepDebDingell @RepMMM @SenatorWicker @RepRobinKelly @RepBarragan @RepAngieCraig @POTUS @RobertKennedyJr @MartyMakary @SenBobCasey @SenatorBaldwin @SenatorHassan @SenTinaSmith @SenMarkey @SenBillCassidy @SenMullin @lisamurkowski @RogerMarshallMD @RepJasonCrow @TeamCalvert @RepBrianFitz @ChrisCoons @RepAndyHarrisMD @DickDurbin @RepMikeQuigley @RepSchakowsky @rosadelauro @RandPaul @RepDonBacon @SenJohnCurtis
.@VPrasadMDMPH, Congrats on your @FDACBER Director appointment. @DrMakaryFDA
I'm a physician dying of ALS. I hope that you will review #FDACBER decision on EFFECTIVE Nurown.
As an Oncologist, I don't know how familiar you are with #ALS & the challenges to research. We have tremendous difficulty showing statistically significant results for efficacy, even for effective treatments, like Tofersen and Nurown.
Tofersen failed to meet its primary endpoint, but was granted accelerated approval for SOD1 ALS (~2% of ALS cases) due to a reduction in Nfl, although not a validated biomarker, was deemed reasonably likely to predict benefit.
There is no doubt about the effectiveness of Tofersen now that there is much more patient experience with longer treatment windows.
The challenges to traditional ALS trials are the significant biological and clinical heterogeneity (not present in the Tofersen trial which also failed to show clinical benefit), the small trial sizes by necessity, lack of validated biomarkers, and a deeply flawed ALSFRS-R questionnaire as a primary endpoint.
15 years after the Phase 1 trial, #PeterMarks asked this small biotech company to do a second Phase 3 trial that will force ALS patients with a median survival of 2-3 years, to die waiting on a trial that will have the same limitations as the previous Nurown trial.
ALS has been 100 % FATAL since it was first identified in 1869. We need you to weigh the preponderance of Patient Reported Outcomes and Real World Evidence that is specifically stated in the FDA ALS guidance document specifically as supporting efficacy.
In addition to this, Nurown had significant biomarker changes, concerning decreased neuroinflammation and neurodegeneration ( including the Nfl that was the reason for Tofersen Accelerated Approval), and increased markers of neuroprotection. Here is the extremely plausible mechanism:
The NurOwn Phase 3 trial for ALS (NCT03280056) evaluated cerebrospinal fluid (CSF) biomarkers related to neuroinflammation, neurodegeneration, and neuroprotection. The following statistically significant biomarker changes were observed in NurOwn-treated participants compared to the placebo group, as reported in peer-reviewed publications and trial data analyses:
Neurofilament Light (NfL):
NurOwn treatment significantly reduced NfL levels from baseline to week 20 compared to placebo (p<0.05). Lower NfL levels indicate reduced neurodegeneration, as NfL is a prognostic biomarker associated with ALS disease progression.
Neurotrophic Factors:
There was a statistically significant increase in neurotrophic factors (e.g., VEGF, HGF) in the CSF of NurOwn-treated participants, while no significant change was observed in the placebo group. These factors support neuronal survival and repair.
Neuroinflammatory Biomarkers:
NurOwn significantly reduced levels of neuroinflammatory biomarkers, such as MCP-1 (monocyte chemoattractant protein-1), in the CSF compared to placebo. This reduction suggests decreased neuroinflammation.
Galectin-1:
Galectin-1 levels were significantly altered in NurOwn-treated participants, contributing to the prediction of clinical outcomes. This biomarker is linked to neuroprotection and anti-inflammatory pathways.
Latency-Associated Peptide of TGF-β1 (LAP/TGF-β1):
Significant changes in LAP/TGF-β1 levels were observed, indicating modulation of neuroprotective and anti-inflammatory pathways in NurOwn-treated participants.
These biomarker changes were consistent across participants, including those with advanced ALS, and were not limited by the ALSFRS-R floor effect that impacted clinical outcome measurements. The biomarker data supported NurOwn’s mechanism of action, targeting neuroinflammation and neurodegeneration while promoting neuroprotection.
Some have died after undeniable benefits with Nurown, but then denied access. I know that there are many who would love an opportunity to sit down with you and @DrMakaryFDA and speak with you for a short time to tell you their undeniable benefits on Nurown.
There is a surge of untreatable brain diseases that you will increasingly see during your time at the @FDACBER. Our lives depend on your understanding of the challenges of our clinical trial & your willingness to apply the same urgency and flexibility as you do for cancer treatments.
156 years of #ALS HOPELESSNESS MUST END. PLEASE invite @BrainstormCell to apply for accelerated approval.
@SecKennedy @realDonaldTrump @lisamurkowski @SenJohnCurtis @GovBraun
.@DrMakaryFDA, ALS patients can’t wait 5 more years for NurOwn’s Phase 3b results
15 years after Phase 1, the Phase 3b trial still faces small samples, heterogeneity, and the flawed ALSFRS-R questionnaire endpoint
NurOwn’s plausible mechanism—stem cells deliver neurotrophic factors to support dying motor neurons in ALS—is backed by Phase 3 data: reduced neuroinflammation markers and improved CSF profiles
Follow the FDA own ALS guidance and weigh the preponderance of unprecedented PRO & RWE showing patient benefits. Also, as you told Megyn Kelly, “For rare, incurable diseases, we may approve based on plausible mechanisms.”
The @FDACBER can follow Nurown efficacy in real time. #CommonSense flexibility for a disease WITH NO SURVIVORS since it was first identified in 1869.
Act now: invite @BrainStormCell for Accelerated Approval. #ALS #FDAAction
@SecKennedy @realDonaldTrump @RepGuthrie @RepLarryBucshon @michaelcburgess @RepGusBilirakis @RepBillJohnson @RepRichHudson @RepBuddyCarter @DrNealDunnFL2 @cathymcmorris @LeaderJohnThune @Cylebo @RepMMM @SenatorWicker @RepRobinKelly @RepBarragan @RepAngieCraig @RepKimSchrier @RepLoriTrahan @BernieSanders @PattyMurray @SenBobCasey @SenatorBaldwin @timkaine @SenatorHassan @SenTinaSmith @SenMarkey @SenBillCassidy @SenMullin @lisamurkowski @RogerMarshallMD @RepJasonCrow @TeamCalvert @RepBrianFitz @ChrisCoons @RepAndyHarrisMD @DickDurbin @SenJohnThune @RepDianaDeGette @RepMikeQuigley @RepSchakowsky @rosadelauro @RandPaul @DorisMatsui @RepDonBacon @SenJohnCurtis
Theodore Randolph, PhD will present "Single-shot, Multi-Dose Vaccines Prepared with Atomic Layer Deposition Techniques" at the 2024 #FDACBER Science Symposium, September 16-18, 2024, at FDA!
Register now to attend, virtually or in person.
https://t.co/PA4h6TCRqv
Jennifer Doudna, PhD will present “How will CRISPR genome editing become a standard of care?” at the 2024 #FDACBER Science Symposium, September 16-18, 2024, at FDA!
Register now to attend, virtually or in person.
https://t.co/PA4h6TDpg3
Donald Kohn, MD will present "Hematopoietic Stem Cell Gene Therapy for Inherited Blood Cell Diseases" at the 2024 #FDACBER Science Symposium, September 16-18, 2024, at FDA!
Register now to attend, virtually or in person.
https://t.co/PA4h6TCRqv
Register to attend #FDACBER's 2024 Science Symposium Sept 16-18, 2024 virtually or in person. Presentation topics include emerging & re-emerging diseases, advanced manufacturing, advances in computational science, cellular, tissue, gene therapies and more! https://t.co/8Yp5sDrlaT
It's day 39 of the 45 days that the @FDACBER has to review the @BrainstormCell SPA.
The only thing guaranteed by Big Pharma shill @DrCaliff_FDA & #FDACBER director Peter Marks is the consistent lack of urgency, humanity, & regulatory flexibility for HORRIFIC 100% FATAL #ALS.
#FDAfailedALS #NurownWorks #CriticalUnmetNeed #CaliffIsCorrupt #100PercentFatal
The EXTREME suffering & deaths continue every day.
YOU OR YOUR LOVED ONE COULD BE NEXT.
@RepGuthrie @RepLarryBucshon @RepAnnaEshoo @michaelcburgess @RepGusBilirakis @RepBillJohnson @RepRichHudson @RepBuddyCarter @DrNealDunnFL2 @cathymcmorris @RepSarbanes @RepCardenas @RepDebDingell @RepMMM @SenatorWicker @RepRobinKelly @RepBarragan @RepKimSchrier @RepLoriTrahan @BernieSanders @PattyMurray @SenBobCasey @SenatorBaldwin @timkaine @SenatorHassan @SenTinaSmith @SenMarkey @SenBillCassidy @SenMullin @lisamurkowski @SenatorBraun @RogerMarshallMD @RepJasonCrow @TeamCalvert @RepBrianFitz @ChrisCoons @RepAndyHarrisMD @DickDurbin @SenJohnThune @RepDianaDeGette @RepMikeQuigley @RepSchakowsky @rosadelauro @RepJohnCurtis @DorisMatsui @chairmang @RepDonBacon
.@FDACBER Peter Marks & @DrCaliff_FDA have 45 days to review the SPA submitted by @BrainstormCell
The EXTREME suffering & deaths continue every day.
The #ALS community has never witnessed any @US_FDA urgency for 100% FATAL #ALS
When do you expect an answer from Peter Marks?
#FDAfailedALS #CriticalUnmetNeed #100PercentFatal #NurownWorks
@RepGuthrie @RepLarryBucshon @RepAnnaEshoo @michaelcburgess @RepGusBilirakis @RepBillJohnson @RepBuddyCarter @DrNealDunnFL2 @cathymcmorris @RepCardenas @RepDebDingell @RepMMM @SenatorWicker @RepRobinKelly @RepBarragan @RepAngieCraig @RepKimSchrier @RepLoriTrahan @BernieSanders @PattyMurray @SenBobCasey @SenatorBaldwin @timkaine @SenatorHassan @SenTinaSmith @SenMarkey @SenBillCassidy @SenMullin @lisamurkowski @SenatorBraun @RogerMarshallMD @RepJasonCrow @TeamCalvert @RepBrianFitz @ChrisCoons @RepAndyHarrisMD @DickDurbin @SenJohnThune @RepDianaDeGette @RepMikeQuigley @RepSchakowsky @rosadelauro @RepJohnCurtis @DorisMatsui @chairmang @RepDonBacon
@crayne128 @DrCaliff_FDA @FDACBER @DrCaliff_FDA SOME ALS patients were lucky to receive NurOwn and stop or even reverse ALS. When #FDACBER rejected NurOwn and DID NOT LISTEN to PwALS we felt you said, ‘Too Bad, Go Die’. There is anger, frustration and outrage. REAL pALS are really dying #StrongEnoughLongEnough
I hope that I'm not the only person emailing.
FDA Commissioner Califf & Director of the #FDACBER Peter Marks' (responsible for the sham #Nurown AdComm hearing) direct email addresses are:
[email protected],
[email protected],
[email protected]
CONGRESS, this is the darkest time in the 154-year #ALS history.
The @FDACBER has killed effective #Nurown sentencing ALL with #ALS to die WITHOUT HOPE.
#FDACBER CORRUPTION & marginalization of 100% PROGRESSIVE & FATAL #ALS has been sickening to watch under the leadership of Peter Marks.
@DrCaliff_FDA allowed this to continue as FDA Commissioner.
Many generations of #ALS patients now have met with & believed #FDACBER Director Dr. Peter Marks' LIES & assurances of regulatory flexibility for 100% fatal ALS.
Dr. Marks' has filled cemeteries with #ALS patients & is now going to fill many more.
BOTH OF THESE FDA OFFICIALS HAVE ALS PATIENTS' BLOOD ON THEIR HANDS.
The vast majority of patients diagnosed today will not survive to see the results of the planned #Nurown Phase 3b trial.
Tens of 1000s have died in the fight for #Nurown & tens of 1000s more now will continue to die WITHOUT HOPE.
#NurownWorks #NurownIsSafe #CriticalUnmetNeed
All of this HORRIFIC suffering & family devastation will occur while an UNDENIABLY effective treatment exists.
CONGRESS, how do you allow this to go on?
CONGRESS, dying #ALS, with broken bodies & no Big Pharma allies, NEED YOU to advocate on our behalf.
#ALS devastates EVERY DAY in EVERY COMMUNITY.
ALS IS NOT RARE & is rapidly becoming more common.
154 years after the first reported #ALS diagnosis, it's still 100% PROGRESSIVE & FATAL today.
MARK MY WORDS. #ALS will directly or indirectly enter many of your lives in the future.
Don't wait for ALS to enter your life to ACT.
@RepGuthrie @RepLarryBucshon @RepAnnaEshoo @michaelcburgess @RepGusBilirakis @RepBillJohnson @SenatorWicker @RepBuddyCarter @DrNealDunnFL2 @cathymcmorris @RepSarbanes @RepCardenas @RepDebDingell @RepMMM @RepAnnieKuster @RepRobinKelly @RepBarragan @RepAngieCraig @RepKimSchrier @RepLoriTrahan @BernieSanders @PattyMurray @SenBobCasey @SenatorBaldwin @timkaine @SenatorHassan @SenTinaSmith @SenMarkey @SenBillCassidy @SenMullin @lisamurkowski @SenatorBraun @RogerMarshallMD @RepJasonCrow @TeamCalvert @RepBrianFitz @ChrisCoons @RepAndyHarrisMD @DickDurbin @SenJohnThune @RepDianaDeGette @RepMikeQuigley @RepSchakowsky @rosadelauro @RepJohnCurtis @DorisMatsui @chairmang @RepDonBacon
Even if you don't have the energy to write a new email, send the same one EVERY DAY, but PLEASE don't stop
It's ideal, if you're comfortable, to include a picture to make it personal
FDA Commissioner Califf & Director of the #FDACBER Peter Marks' (responsible for the sham #Nurown AdComm hearing) direct email addresses are:
[email protected],
[email protected],
[email protected]
CONGRESS, this is the darkest time in the 154-year #ALS history.
The @FDACBER has killed effective #Nurown sentencing ALL with #ALS to die WITHOUT HOPE.
#FDACBER CORRUPTION & marginalization of 100% PROGRESSIVE & FATAL #ALS has been sickening to watch under the leadership of Peter Marks.
@DrCaliff_FDA allowed this to continue as FDA Commissioner.
Many generations of #ALS patients now have met with & believed #FDACBER Director Dr. Peter Marks' LIES & assurances of regulatory flexibility for 100% fatal ALS.
Dr. Marks' has filled cemeteries with #ALS patients & is now going to fill many more.
BOTH OF THESE FDA OFFICIALS HAVE ALS PATIENTS' BLOOD ON THEIR HANDS.
The vast majority of patients diagnosed today will not survive to see the results of the planned #Nurown Phase 3b trial.
Tens of 1000s have died in the fight for #Nurown & tens of 1000s more now will continue to die WITHOUT HOPE.
#NurownWorks #NurownIsSafe #CriticalUnmetNeed
All of this HORRIFIC suffering & family devastation will occur while an UNDENIABLY effective treatment exists.
CONGRESS, how do you allow this to go on?
CONGRESS, dying #ALS, with broken bodies & no Big Pharma allies, NEED YOU to advocate on our behalf.
#ALS devastates EVERY DAY in EVERY COMMUNITY.
ALS IS NOT RARE & is rapidly becoming more common.
154 years after the first reported #ALS diagnosis, it's still 100% PROGRESSIVE & FATAL today.
MARK MY WORDS. #ALS will directly or indirectly enter many of your lives in the future.
Don't wait for ALS to enter your life to ACT.
@RepGuthrie @RepLarryBucshon @RepAnnaEshoo @michaelcburgess @RepGusBilirakis @RepBillJohnson @SenatorWicker @RepBuddyCarter @DrNealDunnFL2 @cathymcmorris @RepSarbanes @RepCardenas @RepDebDingell @RepMMM @RepAnnieKuster @RepRobinKelly @RepBarragan @RepAngieCraig @RepKimSchrier @RepLoriTrahan @BernieSanders @PattyMurray @SenBobCasey @SenatorBaldwin @timkaine @SenatorHassan @SenTinaSmith @SenMarkey @SenBillCassidy @SenMullin @lisamurkowski @SenatorBraun @RogerMarshallMD @RepJasonCrow @TeamCalvert @RepBrianFitz @ChrisCoons @RepAndyHarrisMD @DickDurbin @SenJohnThune @RepDianaDeGette @RepMikeQuigley @RepSchakowsky @rosadelauro @RepJohnCurtis @DorisMatsui @chairmang @RepDonBacon
CONGRESS, this is the darkest time in the 154-year #ALS history.
The @FDACBER has killed effective #Nurown sentencing ALL with #ALS to die WITHOUT HOPE.
#FDACBER CORRUPTION & marginalization of 100% PROGRESSIVE & FATAL #ALS has been sickening to watch under the leadership of Peter Marks.
@DrCaliff_FDA allowed this to continue as FDA Commissioner.
Many generations of #ALS patients now have met with & believed #FDACBER Director Dr. Peter Marks' LIES & assurances of regulatory flexibility for 100% fatal ALS.
Dr. Marks' has filled cemeteries with #ALS patients & is now going to fill many more.
BOTH OF THESE FDA OFFICIALS HAVE ALS PATIENTS' BLOOD ON THEIR HANDS.
The vast majority of patients diagnosed today will not survive to see the results of the planned #Nurown Phase 3b trial.
Tens of 1000s have died in the fight for #Nurown & tens of 1000s more now will continue to die WITHOUT HOPE.
#NurownWorks #NurownIsSafe #CriticalUnmetNeed
All of this HORRIFIC suffering & family devastation will occur while an UNDENIABLY effective treatment exists.
CONGRESS, how do you allow this to go on?
CONGRESS, dying #ALS, with broken bodies & no Big Pharma allies, NEED YOU to advocate on our behalf.
#ALS devastates EVERY DAY in EVERY COMMUNITY.
ALS IS NOT RARE & is rapidly becoming more common.
154 years after the first reported #ALS diagnosis, it's still 100% PROGRESSIVE & FATAL today.
MARK MY WORDS. #ALS will directly or indirectly enter many of your lives in the future.
Don't wait for ALS to enter your life to ACT.
@RepGuthrie @RepLarryBucshon @RepAnnaEshoo @michaelcburgess @RepGusBilirakis @RepBillJohnson @SenatorWicker @RepBuddyCarter @DrNealDunnFL2 @cathymcmorris @RepSarbanes @RepCardenas @RepDebDingell @RepMMM @RepAnnieKuster @RepRobinKelly @RepBarragan @RepAngieCraig @RepKimSchrier @RepLoriTrahan @BernieSanders @PattyMurray @SenBobCasey @SenatorBaldwin @timkaine @SenatorHassan @SenTinaSmith @SenMarkey @SenBillCassidy @SenMullin @lisamurkowski @SenatorBraun @RogerMarshallMD @RepJasonCrow @TeamCalvert @RepBrianFitz @ChrisCoons @RepAndyHarrisMD @DickDurbin @SenJohnThune @RepDianaDeGette @RepMikeQuigley @RepSchakowsky @rosadelauro @RepJohnCurtis @DorisMatsui @chairmang @RepDonBacon
YEARS OF BROKEN PROMISES of @FDACBER regulatory flexibility followed by a SHAM #Nurown AdComm hearing have left generations with 100% FATAL #ALS to die WITHOUT HOPE.
CONGRESS, @DrCaliff_FDA & #FDACBER's decision to deny MANY with #RealWorldEvidence to testify, ignoring YEARS of UNPRECEDENTED benefits in AdComm patient testimonies, & disregard for over 1900 submitted AdComm comments (>150 from physicians in support of approval) shows how CRUEL the #FDACBER regulatory RIGIDITY is for a 100% PROGRESSIVE & FATAL disease.
CONGRESS, @DrCaliff_FDA & Director of the
@FDACBER, Peter Marks, have killed effective #Nurown for 100% FATAL #ALS.
They have refused to follow the regulatory flexibility outlined in their own 2019 FDA ALS Guidance for Industry.
CONGRESS, PLEASE don't go on with business as usual as tens of 1000s more #ALS die WITHOUT HOPE.
It may be you or your loved one tomorrow who is diagnosed with this DEATH SENTENCE because of this continuation of the CRUEL #FDACBER regulatory RIGIDITY for a disease WITH NO SURVIVORS since 1st identified in 1869.
Hold the @US_FDA accountable for this terrible injustice.
#NurownWorks #NurownIsSafe #CriticalUnmetNeed
@RepGuthrie @RepLarryBucshon @RepAnnaEshoo @michaelcburgess @RepGusBilirakis @RepBillJohnson @RepRichHudson @RepBuddyCarter @DrNealDunnFL2 @cathymcmorris @RepSarbanes @RepCardenas @RepDebDingell @RepMMM @RepAnnieKuster @RepBarragan @RepAngieCraig @RepLoriTrahan @BernieSanders @PattyMurray @SenBobCasey @SenatorBaldwin @SenatorHassan @SenTinaSmith @SenMarkey @SenBillCassidy @SenMullin @lisamurkowski @SenatorBraun @RogerMarshallMD @RepJasonCrow @TeamCalvert @RepBrianFitz @ChrisCoons @RepAndyHarrisMD @DickDurbin @SenJohnThune @RepDianaDeGette @RepMikeQuigley @RepSchakowsky @rosadelauro @RepJohnCurtis @DorisMatsui @chairmang @RepDonBacon
In the past, the #ALS community has been EXTREMELY passive relative to the horrible injustice we face.
I hope that the community is not accepting the CRUEL #FDACBER regulatory RIGIDITY leaving so many to die WITHOUT HOPE.
#NurownWorks
Even if you don't have the energy to write a new email, send the same one EVERY DAY, but PLEASE don't stop.
It's ideal, if you're comfortable, to include a picture to make it personal.
FDA Commissioner Califf & Director of the #FDACBER Peter Marks' (responsible for the sham #Nurown AdComm hearing) direct email addresses are:
[email protected],
[email protected],
[email protected]
I email them EVERY DAY, but if it's just me it's very easy to ignore. I hope that hundreds and even thousands of people affected by #ALS will be bold and join me.
#ALS will be quickly forgotten if the ALS community goes silent.
The ALS community is about to lose so many good people who just wanted a chance at survival.
I'm devastated & I don't want Califf & Marks to be able to go on with their lives comfortably as the FDA has always been able to do after lying directly to the faces of dying ALS generation after generation.
I wish others felt the same way. ALS patients quickly give up because the disease makes fighting for anything other than just surviving every day so difficult.
#NurownWorks #NurownIsSafe #CriticalUnmetNeed #BloodOnYourHands
If you feel the same way, but like me aren't physically able to protest, let them hear EVERY DAY from MANY #ALS patients whom they have sentenced to death.
Their direct email addresses are:
[email protected],
[email protected],
[email protected]
I intend to email them EVERY DAY, but if it's just me it's very easy to ignore. I hope that hundreds and even thousands of people affected by #ALS will be bold and join me.
Generations with #ALS, who have PLEADED with Peter Marks #FDACBER for regulatory flexibility, fill cemeteries. Only broken promises remain.
Let FDA Commissioner Califf & Peter Marks of the #FDACBER hear EVERY DAY from MANY #ALS patients whom they have sentenced to death.
#ALS will be quickly forgotten if the ALS community goes silent.#NurownWorks #NurownIsSafe #CriticalUnmetNeed #BloodOnYourHands #EnoughIsEnough
Their direct email addresses are:
[email protected],
[email protected],
[email protected]
I email them EVERY DAY, but if it's just me it's very easy to ignore. I hope that hundreds and even thousands of people affected by #ALS will be bold and join me.
In #ALS, I've learned we always have less time than we think.
@BrainstormCell @Cylebo @StacyLindborg @jacobfrenkel, the vast majority of the ALS community knows that #NurownWorks & the horrible tragedy if the #FDACBER doesn't approve.
As someone who has fought for #Nurown EVERY DAY for years, your silence is unbearable.
The community has been doing all it can, but the issues brought up at the sham AdComm are things that only you can address.
Many lives have counted on your leadership & I believe that although the #FDACBER is undoubtedly corrupt & biased against Brainstorm, you have let dying #ALS down.
Experienced Pharma leadership MUST be able to anticipate these issues & be immediately prepared to address them. Instead, the message consistently given by your leadership has been that the #FDACBER has been very accommodating & cooperative.
Then we watched helplessly as the #FDACBER DESTROYED everything from the trial floor effect, biomarker evidence, manufacturing, etc at the AdComm hearing.
It was difficult to watch, but even more difficult to understand how after all of your communication with the #FDACBER you didn't see it coming.
Without any action, I don't think that anyone expects approval after the sham #FDACBER AdComm hearing.
I pray that you, @Cylebo @StacyLindborg @jacobfrenkel, are doing EVERYTHING POSSIBLE to prevent this even if it means giving up some power, control & financial gain. PLEASE HURRY.
The ALS community has been fighting nonstop for years. So many will suffer horribly & die if #Nurown is denied approval.
A formal request was made by the #ALS community for more time so that everyone who received #Nurown could speak.
If you're interested in the Truth, you allow this.
Also, you don't set up an AdComm hearing where the #FDACBER trashes the company & trial right before the vote & don't allow time for Brainstorm to respond.
It was set up for #Nurown to fail.
For those of us whose lives are on the line, your (@BrainstormCell) silence with less than 2 months before the PDUFA date is very concerning.
Without any action, I don't think that anyone expects approval after the sham #FDACBER AdComm hearing.
I pray that you, @Cylebo @StacyLindborg @jacobfrenkel, are doing EVERYTHING POSSIBLE to prevent this even if it means giving up some power, control & financial gain.
The ALS community has been fighting nonstop for years. So many will suffer horribly & die if #Nurown is denied approval.
The #ALS community is about to lose FOREVER the most effective treatment in its 154-year history.
#NurownWorks
With this loss will come IMMEASURABLE suffering, deaths, & devastation of families for generations WITHOUT HOPE.
I pray that you, @BrainstormCell @Cylebo @StacyLindborg @jacobfrenkel, are doing EVERYTHING POSSIBLE to prevent this even if it means giving up some power, control & financial gain.
PLEASE don't underestimate the corruption of the @FDACBER & the power/unfortunate influence of the National @alsassociation.
#EndALS
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