SaveThePlanet 🌎

When will shareholders and investors realize that AI can replace most CEOs and boost EPS along the way too 😁🤷‍♂️ $spy $nasdaq #StockMarket

@NoMonkeyBusine4 @DrMakaryFDA Dr. Makary, it is time to walk the talk for Deramiocel, DMD patients and their families.

So, if you one of your underlings does not put it ON FRONMT of you, then you have an excuse for not signing it, right? Deramiocel. Stat sig on all primary and secondary endpoints. Muscular Dystrophy needs ..... compassion, no? No other drug that does what Deramiocel does. Get on your horse, doctor. ADVICE: Find out WHY it's NOT in front of you. Are they wrong? Are they lazy? Are they corrupt? Let's go!

I’ve signed 100% of compassionate use requests that have come to my desk.

@ENIGMATICSTOCKS On a separate thread, I looped in Capricor so their legal team can look into this person's claims. x.com/USAPatriot16/s…

This is what happens in today's world when. you make accurate posts. Blocked by @anthonystaj who recently pushed out some absolute garbage regarding #capricor $capr. When faced with facts, he simply blocks you as he cannot have a argument on his page in good faith. Literally bottom feeder page who should be investigated @SECGov Market Manipulation passing off opinions as fact is no better than what sent many to prison whom he associates with. Before you short $CAPR, ask yourself, is some page with a few followers worth risking it all for? Doubt it. Wait for the results.

The Han Phan letter in Anthony's thread was neither related to @Capricor nor its Hope trials. I hope the company's legal team looks into these claims. $CAPR

@adamfeuerstein Did not Prasad have an issue with how prior FDA gave $SRPT a pass? How will they make their case to VP with this latest study?

$SRPT still has never conducted a successful Phase 3 or confirmatory study.

@bennyjohnson About time! This was totally despicable by @jimmykimmel

@Elijahjstacy Your efforts are tireless and very valuable.

Made a new friend with a DMD parent today. Has contacts with her senator. Feels strongly about Capricor. Let’s keep it going and unite the community! We MUST have it.

@MadaamCurie1911 @Elijahjstacy He has DMD, you do not and you are questioning his efforts here? Shame on you.

@elonmusk @LauraLoomer Prasad blocked the DMD Cure Drug whose study had a p value of 0.0066. Please read Elijah's Mom's heartfelt open letter to @realDonaldTrump

@preta_6 I agree, you do not need to pre phase anything to simply say: "RIP Charlie Kirk"

Let’s retire the phrase “I disagreed with much of what he said, but…” I don’t care. The phrase is meant to manage how others perceive you, and to stop others from finding you guilty of holding the “wrong” opinions. It’s toxic. It’s part of the problem.

@Elijahjstacy @realDonaldTrump @VP @SecKennedy Stacy's letter is spot on. FDA Chief Makary says rare diseases are huge a priority, but $CAPR received a CRL full of errors (blamed on AI) The study data had a p value of 0.0066 - statistically significant. Please give the DMD Boys hope.

President Trump — my mom’s greatest desire has always been to see her kids get better. Even while battling Stage IV pancreatic cancer, she is still fighting for that day. Please read her letter to you. I ask you to intervene, as you have before, to cut through the red tape and help save my life — and the lives of thousands living with Duchenne Muscular Dystrophy. Please share this. We need every voice. @realDonaldTrump @WhiteHouse @JDVance washingtonexaminer.com/op-eds/3808452…

@Elijahjstacy Please tell these impactful people that FDA is not walking the talk. Here is my post calling out Makary. x.com/USAPatriot16/s…

Tomorrow ((hopefully)) you will read one of the most powerful and inspiring things ever. Some U.S officials have already read it, quite literally, in the United States Capitol Building and so has Dennis Prager and others. It is also being worked on being sent to powerful Senators, one who has ran for President. And it’ll also be directly sent to the Speaker of the House through a contact I know. Let’s get a win for the DMD community! The Stacy family will use its suffering to help others overcome theirs. Stay tuned and please be ready to share this tomorrow — we need all voices!

@DrMakaryFDA @US_FDA @SecKennedy If rare diseases are huge a priority, how come $CAPR received a CRL full of errors ???(blamed on AI) The study data had a p value of 0.0066 - statistically significant. A patient story from @Elijahjstacy below x.com/Elijahjstacy/s… Time for FDA to walk the talk

Rare diseases are a huge priority for this @US_FDA!

@Elijahjstacy Please send Capricor CRL Response letter to the Senator you have met with and the others you can. The responses in this letter paint a clear picture for why deramiocel should have been approved and FDA had no statistical argument to issue the CRL. x.com/AscendingBio/s…

As the founder and leader of a DMD nonprofit, I meet and speak to patients and parents on a daily basis. They want deramiocel and it gives a lot of hope to patients, me included, starting to face cardiac decline. Every single day, weekends included, I have been working on helping get this approved. I am going up to bat for the DMD community and myself. I am now publicly calling on, as a patient, for other PATIENT advocacy groups and patients to start to speak publicly about their need and desire to get access to deramiocel. What I want to make clear is this isn’t just another little drug that will make small improvements, but a drug that can potentially rewrite the prognosis of DMD by adding decades to one’s life. #1 cause of death in DMD is cardiomyopathy and you’re potentially addressing that issue completely in one go. As a patient, it’d be very nice to remove/greatly reduce the biggest cause of death from my things to worry about. So let’s come together, DMD community, and make this happen. I have big plans to help get this through, but I’ll take more than just me. Let’s go win!

@AscendingBio The DMD patients' lives should not be impacted due to an FDA executive who cannot comprehend data analysis. @MartyMakary @RobertKennedyJr you need to fix this and hire qualified leaders.

$CAPR Highlights of Today's Presentation -Verbal agreement that the FDA will keep the current BLA open and that they will accept HOPE-3 data. (My guess is that FDA will be able to approve this med within 3 to 5 months of receiving the HOPE-3 data. This includes a few weeks to sort out the text for the label. Linda has not said how long the HOPE-3 data will take to analyze once they have written guidance from FDA. ) -Still working with the FDA to agree to plan for how to analyze the HOPE-3 data. This should include making LVEF the primary outcome measure. -Statement that AI may have been the issue with FDA's flawed statistical analysis. My guess is that points to Prasad's use of AI and his lack of understanding of nonparametric statistics. I think FDA has staff members that understand this, but their expertise was not used.

@TequilaVernetti @LauraLoomer was right about Vinay Prasad!

@RFKJr_Official @SecKennedy @DrMakaryFDA @realDonaldTrump Time is muscle and I hope you support great science and let $CAPR save lives by bringing Deramiocel to market! #DMD

@leffler_aidan @RFKJr_Official @SecKennedy @DrMakaryFDA Time is muscle and I hope you support great science and let $CAPR save lives by bringing Deramiocel to market. Everything you have said publicly about rare diseases and approvals are in line with what this drug does.

I’m 22. I live with DMD. A treatment helped me hold onto my independence, graduate college, and live on my own. Now it might be taken away—not because it failed, but because we’re measuring the wrong things. Watch my story. Share it. I need your help. #DMD

@DrMakaryFDA How come $CAPR gets the cold shoulder with 4 year Hope 2 OLE data and almost 2 years of Hope 3 ??? You need to have a consistent and fair approval cycle to have any credibility at FDA! Time is muscle and the approval delays are costing DMD Boys.

FDA is proud to have approved another gene therapy. We are committed to regulatory flexibility when it comes to novel technologies. We must modernize our processes to meet the needs of patients.

@RobertSeafarer @MilaLovesJoe with a bunch of plastic interventions.

@MilaLovesJoe I think she’s aged wonderfully for a person who went through multi decades of stress. Did she make poor choices yes, but the President of the US is more to blame. He used his power in an abhorrent way, then told us all he didn’t!🤷‍♂️

Whats the first thing you think of when you see Monica Lewinsky?

@LauraLoomer @RogerJStoneJr It is time to clean up the FDA so that they do not block innovation. I cannot believe that Makary dared to rehire Prasad! At this point, they should both go!

I told Roger Stone @RogerJStoneJr that anyone who undermines President Trump or refuses to carry out the MAGA mandate will be exposed and made politically irrelevant. Loyalty is non-negotiable. Roger agreed and pointed out that Trumpism is bigger and more popular than the Republican Party itself. We also discussed how the Democrats’ obsession with Jeffrey Epstein will backfire when the public sees who was really on that island and taking his money. Not to mention, Jeffrey Epstein associate Reid Hoffman @reidhoffman is currently one of the top 3 biggest donors to the Democrat Party.