Aggie. Texan. Entrepreneur. ALS Advocate living with ALS.
Joined May 2017
- Tweets 3,786
- Following 439
- Followers 719
- Likes 9,700
31 Photos and videos
Craig Reagan retweeted
Thinking of three young adults without their Dad is heartbreaking, and imagining six children without their mother is devastating and unthinkable.
Thank you @people and @MinoShah for not ignoring the devastation #ALS brings to families and for shining a light on these stories.
#Budget2027 #PeopleNeedtoKnow
Jun 13
#ALS is 100% fatal and can strike anyone without warning. Because we physically lose the ability to advocate for ourselves, we are easily ignored.
@FDA_KyleD @SecKennedy @FDACBER: Our NurOwn Citizen's Petition is >160 days overdue. Why is the FDA turning a blind eye?
people.com/she-was-tripping-…
@RepGuthrie @DrOz @DrOzCMS @RepGusBilirakis @SenRonJohnson @ChuckGrassley @SecKennedy @RobertKennedyJr @RepRichHudson @RepBuddyCarter @DrNealDunnFL2 @LeaderJohnThune @RepDebDingell @RepMMM @SenatorWicker @RepRobinKelly @RepBarragan @RepAngieCraig @RepKimSchrier @RepLoriTrahan @SenatorBaldwin @SenatorHassan @SenTinaSmith @SenMarkey @SenBillCassidy @SenMullin @lisamurkowski @RogerMarshallMD @RepJasonCrow @TeamCalvert @RepBrianFitz @ChrisCoons @RepAndyHarrisMD @DickDurbin @RepDianaDeGette @RepMikeQuigley @RepSchakowsky @rosadelauro @RandPaul @RepDonBacon @SenJohnCurtis
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Craig Reagan retweeted
Jun 14
The ALS community saw the Nurown AdComm wasn't seeking the truth. We compiled the survival data ourselves & submitted a Citizen's Petition
@FDACBER has delayed it for >160 days with zero response
@SecKennedy @FDA_KyleD @SenRonJohnson @houmanhemmati @BellinaMatthew @BellinaDeb @RonJohnsonWI @realDonaldTrump @RobertKennedyJr @RepAndyHarrisMD @RepGuthrie @RepGusBilirakis @SenatorWicker @lisamurkowski @SenatorCollins
I am confident he’s being serious re AdComs. Thats good for FDA and it’s great for patients. Put drugs on “trial” for everyone to see.
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Craig Reagan retweeted
Jun 13
#ALS is 100% fatal and can strike anyone without warning. Because we physically lose the ability to advocate for ourselves, we are easily ignored.
@FDA_KyleD @SecKennedy @FDACBER: Our NurOwn Citizen's Petition is >160 days overdue. Why is the FDA turning a blind eye?
people.com/she-was-tripping-…
@RepGuthrie @DrOz @DrOzCMS @RepGusBilirakis @SenRonJohnson @ChuckGrassley @SecKennedy @RobertKennedyJr @RepRichHudson @RepBuddyCarter @DrNealDunnFL2 @LeaderJohnThune @RepDebDingell @RepMMM @SenatorWicker @RepRobinKelly @RepBarragan @RepAngieCraig @RepKimSchrier @RepLoriTrahan @SenatorBaldwin @SenatorHassan @SenTinaSmith @SenMarkey @SenBillCassidy @SenMullin @lisamurkowski @RogerMarshallMD @RepJasonCrow @TeamCalvert @RepBrianFitz @ChrisCoons @RepAndyHarrisMD @DickDurbin @RepDianaDeGette @RepMikeQuigley @RepSchakowsky @rosadelauro @RandPaul @RepDonBacon @SenJohnCurtis
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Craig Reagan retweeted
Is a total sin the neglect that they have on an ALS patient who are dying or will die. When there is a treatment that can help many patients, the bottom line is FDA is the 1 killing them, by not allowing NurOwn. Your day will come & I’m hoping it’s with ALS, feel our destruction
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Craig Reagan retweeted
@alsassociation is as bad as the FDA. Corrupt and only cares about $$$$
A total disgrace. They’re the ones who should be diagnosed with ALS. Feel our destruction and you will have a change of heart. Or maybe not?
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Craig Reagan retweeted
I would throw in everyone at @alsassociation along with the rest of the FDA! I wouldn’t wish this disease on anyone but I wouldn’t loose sleep if it was one of them!
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I won't be mad if there's a special place in HELL for Marty Makary, Vinay Prasad, Robert Califf, Peter Marks, Stephen Hahn, Scott Gottlieb, & Janet Woodcock, and others that conspired against/ignored, NurOwn, and the ALS community! @Ml1969 @MinoShah @Humbl4now @Vita_Victoria2
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Craig Reagan retweeted
We only wish for someone who has a heart and cares about fatal patients. 🙏🙏
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Craig Reagan retweeted
I think approval of the NurOwn Citizens Petition would be a turning point for the FDA. It says, we are ready to modernize, we are ready to listen, we are ready to put patients first, especially for 100% fatal rare disease with unmet need. @FDA_KyleD has signaled a shift that was desperately needed, and expressed there is more to come. @houmanhemmati @SecKennedy
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The establishment of government regulators & academicians have failed ALS patients and their families for 10 years. How many hundreds of thousands suffering patients could have been treated if they listened to phase 2 patients who testified the benefits of the treatment?
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Craig Reagan retweeted
FDA’s own CBER precedent confirms that real-world evidence, external controls, natural history, compassionate-use data, survival, biomarkers, and single-arm/open-label evidence can serve as substantial evidence for approval, especially in serious rare/fatal diseases where conventional trials are ethically and practically limited.
Given NurOwn’s established safety profile, clinical findings, biomarker evidence, and the totality of data accumulated over years of study and expanded access, @FDACBER should move urgently to evaluate every available regulatory pathway that could provide patient access NOW while additional evidence continues to be generated.
#NurOwn should be approved immediately! @FDA_KyleD @aVoice4ALS @MinoShah @houmanhemmati @PeterPitts @BrainstormCell @iamalsorg
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Craig Reagan retweeted
Jun 4
BrainStorm levels up, bringing on former FDA leader Peter Pitts for new ALS bid biospace.com/drug-developmen…
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Craig Reagan retweeted
The June 3 FDA Rare Disease Roundtable reinforced several principles that directly apply to ALS and #NurOwn
• Rare disease decisions should consider the totality of evidence, not just a single traditional efficacy analysis.
• Patient perspectives and tolerance for uncertainty matter, especially in fatal diseases with no cure.
• Congress intended FDA to use regulatory flexibility when conventional trials are impractical.
• Real-world evidence, external controls, biomarkers, and natural history data all have a role in evidence generation.
For ALS patients facing certain progression and death, these are the very tools FDA has available to make patient-centered decisions when unmet need is profound.
There is no longer any question the NurOwn Citizens petition should be approved.@FDA_KyleD @SecKennedy @aVoice4ALS @iamalsorg @BrainstormCell @PeterPitts @Neuroscope_mp @MGHNeurology @CraigReagan2 @MinoShah
everylifefoundation.org/fda-…
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Craig Reagan retweeted
I’m from Hico, TX and someone impacted by #ALS. @judgecarter, please increase ALS research funding in the FY2027 budget. This funding helps drive treatments and hope for a cure. See why it matters: als.org/2027ALSResearchFundi…
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Craig Reagan retweeted
Good luck to @iamalsorg in today’s FDA meeting.
ALS patients don’t need perfection from the system. They need a chance.
Every day spent waiting for certainty is a day patients may never get back. There is no better example than the 330 days now patients have been waiting for the NurOwn Citizens Petition Approval which could have improved outcomes of ~5000 US lives in those 330 days.
The question isn’t just whether FDA can be flexible in ALS.
The question is whether we can afford not to be.
#NurOwn @PeterPitts @Neuroscope_mp @houmanhemmati @FDA_KyleD @sabrevaya @bsw5020 @aVoice4ALS
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Craig Reagan retweeted
Jun 3
Pleading with @FDACBER and @US_FDA to heed RWE in #NurOwn Citizens Petition, including 7 YRS of unprecedented survival data In EAP compared to 2.5 yrs in natural history. Grant Accelerated Approval for people with #ALS just like you did these therapies.
SEE Petition at NurOwnWorks.com
@FDA_KyleD @FDACommissioner
@SecKennedy @POTUS
FDA is committed to advancing Real-World Evidence use in regulatory submissions across product centers & today updated its list of examples of how RWE has informed FDA's regulatory decisions since 2011. CDRH is now included, along with CDER, CBER & OCE. fda.gov/science-research/rea…
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Craig Reagan retweeted
Jun 3
Sure hope they respond to the 300 page #NurOwn Citizens' Petition containing unprecedented 7 yr survival data for #ALS dwarfing 2.5 yr natural history.
@CBER had 180-day deadline and its now been over 330 days. Only communication was one form letter from Szarama.
Urgency has always been woefully lacking for terminal #rarediseases.
Unfathomable that outcome today is no different than when #LouGehrig died on this day in 1941.
NurOwn helps people live longer & live better.
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Craig Reagan retweeted
.@PeterPitts was once critical of @BrainstormCell. He then looked at the science, the patients, and the unmet need and changed his mind.
At the same time, FDA leadership @FDA_KyleD @SecKennedy are taking a fresh look at how therapies for rare and fatal diseases should be evaluated.
Maybe the question isn’t whether the system should be more flexible.
Maybe the question is why ALS patients have had to wait so long for that flexibility to be applied. Thank you @hmac8
biospace.com/drug-developmen…
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Craig Reagan retweeted
Jun 3
Sure hope they respond to the 300 page #NurOwn Citizens' Petition containing unprecedented 7 yr survival data for #ALS dwarfing 2.5 yr natural history.
@CBER had 180-day deadline and its now been over 330 days. Only communication was one form letter from Szarama.
Urgency has always been woefully lacking for terminal #rarediseases.
Unfathomable that outcome today is no different than when #LouGehrig died on this day in 1941.
NurOwn helps people live longer & live better.
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Craig Reagan retweeted
Thank you Sir @PeterPitts for a very thoughtful, comprehensive review.
Although ALS is the primary example you use in this review, the same principles are applicable in terminal disease like Huntington's Disease. $QURE
May 30
The issue is no longer whether regulatory modernization is necessary. That debate has largely been settled. The issue now is whether review culture and operational decision-making will evolve quickly enough to keep pace with scientific reality. publichealth.realclearjourna…
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