Michael Neri

Father, husband, and golf enthusiast

[Michael Neri @mcneri_1]

@stevehunsaker1 Wait till you shop for curtains / drapery

[Shah Minokadeh, M.D. @MinoShah]

Adam, you may not know, because I fight for Nurown approval every day, that these years #DyingWaiting has left me a quadriplegic with a trach. It's very difficult for me mentally to debate with a clearly biased journalist.

I will post this response, but I'm staring death in the face every day and I need a break from you, Adam.

Because of your unwavering certainty on this issue (before the AdComm hearing), I will assume in my response that you have vast knowledge about ALS & have had experiences with ALS patients.

When the AdComm arrives, if many people come with objective evidence from their neurologists of significant respiratory function improvement and/or a halt or improvement in their progression, will that be significant in your opinion considering your knowledge of ALS and experience with ALS patients? Will you call this RWE or anecdotes?

You may not know this, but these improvements are not always captured by the ALSFRSR questionnaire, which is the primary endpoint measure in ALS trials. The 2019 FDA ALS Guidance for Industry recognized these challenges & acknowledged that improvement in respiratory function is a sign of efficacy & must be considered along with Patient Reported Outcomes. Why don't you recognize this, considering your knowledge of ALS & experience with ALS patients?

You didn't acknowledge this point last time we spoke, but it's very significant. ALS is a heterogeneous disease with significant biological & clinical variability. In addition, by necessity, the trial sizes are very small. These are undeniable challenges to showing efficacy in clinical trials. Even so Adam, can you tell me how many FDA-approved drugs even for a single disease process would have reached statistical significance if the treatment group in their trials were only 100 patients like in the Nurown trial? Can we agree that this would affect the statistical significance of many drugs that have been FDA approved?

I question your ethics because you have the credentials to know that flaws can exist in trials & the FDA drug approval process. I have no doubt that you have the knowledge to argue either side of the case with incomplete data, but you have chosen to fight against the only hope for survival for so many in the ALS community. Many good people died fighting for ALS regulatory flexibility & #Nurown approval. Your clear, persistent, & vocal bias is evident before hearing the AdComm hearing evidence.

You refer to yourself as the "Night King of biotech", which for people who don't know, is a villain from Game of Thrones. I assume that this is in reference to a certain pride you take in being able to destroy biotech companies.

Unfortunately for dying ALS patients & our loved ones, @StatNews has given you the platform to potentially destroy Brainstorm. I wonder why you are so intent on doing this before hearing the evidence presented at the AdComm hearing when so many lives are at stake? I suspect that whatever is fueling your bias is stronger than any evidence presented though, no matter how substantial.

Just for full disclosure, @adamfeuerstein, has your journalistic integrity ever been called into question before? I think it's very important to disclose this. @StatNews @megtirrell @matthewherper @edsilverman @CREWcrew @Linda_Pizzuti @rickberke @GideonGil @StevePearlstein @thekibosch @eemershon @JasonUkman @egoode @SarahLizChar @meggophone @damiangarde @ADeAngelis_bio @JonathanWosen @JonathanWosen @washingtonpost

I will stop here because it's exhausting to type with my eyes & debate with someone who has made it clear that he won't change his mind regardless of what evidence is presented, including at the AdComm hearing.

@rickberke, it's been 154 years of ALS being 100% fatal & we still have to spend our dying days fighting for the same FDACBER urgency & flexibility as cancer treatments. ALS patients, with broken bodies & no Big Pharma allies, cannot battle biased unprofessional journalists from respected news outlets like Stat News while fighting for our lives. I urge you to use another biotech journalist to cover Brainstorm and its AdComm hearing.

It's very difficult to deal with the fact that people like you exist in this world, Adam.

[Shah Minokadeh, M.D. @MinoShah]

My 2nd tweet on Twitter in 2019 below about Matt Bellina receiving #Nurown & standing up from his wheelchair for the 1st time in 2 years.

His breathing numbers went back to normal & he was also able to go off his bipap at night. All of this is in 100% progressive & fatal #ALS

It's hard to think how much I have deteriorated since then, how many who also fought for Nurown we've lost, & the terrible @FDACBER regulatory RIGIDITY that has us still fighting for #Nurown many years later. @DrCaliff_FDA
#NurownWorks #NurownIsSafe

@RepGuthrie @RepLarryBucshon @RepAnnaEshoo  @SenBillCassidy @SenMullin @lisamurkowski @SenatorBraun 
@RepJasonCrow @TeamCalvert @RepBrianFitz @RepTerriSewell @ChrisCoons @RepAndyHarrisMD

[Brian Wallach @bsw5020]

It happened. Today, @US_FDA granted accelerated approval for Tofersen.

This is a huge day for the entire ALS community and, in particular, the families who have SOD1-ALS. Today, they finally have some hope.

https://t.co/iYAN6HAnON

[Synapticure @synapticure]

We are thrilled to announce that Synapticure has received IRB approval to launch a study treating presymptomatic carriers of pathogenic ALS-associated genes with Riluzole.

What, exactly, does that mean?

https://t.co/009JP6voOr

[Governor Mike Braun @GovBraun]

Americans with life-threatening diseases don't have time to wait for FDA red tape and bureaucracy. They need treatments NOW.

Thanks @SenGillibrand for joining me on the #PromisingPathways Bill. I urge my colleagues to get this across the finish line.

[NM Neurology @NMNeurology]

In two new studies, Hande Ozdinler, PhD (@DrOzdinler), and colleagues identify two independent ways to reduce the destruction of the upper motor neurons diseased with TDP-43 pathology in ALS by calming the astrocytes and microglia. Read more:
https://t.co/CKpWbaiLYc

[Michael Neri @mcneri_1]

Take ur chance guys! @0xMattGray @MahTrader13 @cobala089 @KVPROS @QueenBeeChange @Hernandez_434 @dotlder @MWZQ66 @suppartnft @cVGX3NMG1hr3LQ4 @chuparustammm @sticoin @314Crypto @Garrym0_0n @YatoroGodXyz

[Michael Neri @mcneri_1]

@BenKanabi @ElemNFT @INFERNO_GAM3Z @web3astrology @OxApril571M_win @0xjack__ @didem_sonar @mshahrf1 @Rryuawrr @realadamperez @MetalHead_014 @myd84425539 @qirui_shu @MajumderDibyo @up_to_crypto

[Jatara McGee @jatara_]

Yesterday, Matt Mangine shared his son's story in DC to advocate for the Access to AEDs Act. Tonight the Kentucky legislature sent a bill to @GovAndyBeshear's desk that will improve access to AEDs in Ky schools. Happy @TMMJFoundation is seeing progress in the push to save lives.

[L Brielmaier @BrielmaierL]

DNA Treatment Could Delay Paralysis That Strikes Nearly All Patients With ALS - Neuroscience News
https://t.co/XVOxVoWdh0
This needs to be funded into overdrive!
@Nadia_Sethi @VPResearch_ALS @MDAorg @ALSMNDAlliance @alsone_official

[Brian Wallach @bsw5020]

Breaking news: there will be an AdComm for NurOwn.

Thank you to everyone who asked for this. It is time to let the science speak for itself. #NurOwnWorks

[Brian Wallach @bsw5020]

This is not the outcome we hoped for, but the fight to approve tofersen is far from over.

The FDA will decide whether to approve by April 25.

Until then, please keep sharing your stories about tofersen and keep pushing for approval.

This fight is all of our fight.

[Kelsie Snow @kelsieswrites]

Today an FDA-convened advisory panel voted 3-5 against Tofersen, the medicine we know unequivocally is the reason Chris is alive today. The @US_FDA can still make the right choice and approve Tofersen next month. Please watch our full testimony. ❤️ https://t.co/ZHezbBA8vL

[Brian Wallach @bsw5020]

With Relyvrio, we saw @US_FDA finally live up to the words in the 2019 guidance.

With Tofersen, we are asking the FDA to do the same. The science shows that Toferesen is safe and has the potential to slow or stop SOD1 ALS.

It has taken 30 years to get here. #ApproveTofersen

[Kelsie Snow @kelsieswrites]

To be clear, my husband is alive and skating almost 4 years after a doctor diagnosed with an aggressive form of ALS and gave him 6-12 months to live for one reason: Tofersen.

Please pay attention @US_FDA. Tofersen works and it means everything to my family. #ApproveTofersen

[Brian Wallach @bsw5020]

I am really excited as well! @JinsyMd is one of the most progressive and well-informed ALS doctors you will ever meet. @DGeeEss1 and Jinsy are a breath of fresh air.

If you have ALS or are caring for someone with ALS, I hope you will join this amazing webinar.

[The Matthew Mangine, Jr. One Shot Foundation @OneShotFndtn]

Save the date for our signature annual event! The 3rd Annual Matthew Mangine Jr. Foundation Golf Outing takes place on June 11 - 12, 2023 at Triple Crown Country Club in Union, Ky. Enjoy dinner and golf, along with raffles, guest speakers, and more. #OneShotToSaveALife

[Brian Wallach @bsw5020]

I am living with a terminal disease. I am also a patient advocate.

I am a damn good advocate, but I need your help. The more followers I have, the more I can get government and pharma to pay attention.

So my ask is: Will you follow me so we can change the world?

[Shah Minokadeh, M.D. @MinoShah]

WHAT WILL IT TAKE TO GET @DrCaliff_FDA & @FDACBER TO TREAT 100% FATAL #ALS WITH URGENCY/FLEXIBILITY?

ALS is an avoidable tragedy today.
YEARS of being marginalized at the #FDA have allowed the EXTREME suffering/deaths to continue

We NEED Congress to fight for dying constituents, present & future.
#NurownWorks #NoAdComNoVoice

@RepAnnaEshoo @janschakowsky @brettguthrie @rosadelauro @RepJohnCurtis @cathymcmorris @RepFredUpton
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@SenJohnThune @RepDianaDeGette @BillCassidy @ChrisCoons @SenatorBraun @lisamurkowski @DickDurbin