Forever DNA

[Forever DNA @Forever_DNA]

At this point, I'm convinced only 1 thing will move $SRPT stock up to a more fair valuation:
Official announcement that Ingram is gone & they've replaced him w qualified. competent CEO.
Hard to leave when you're raking in Millions, but do it NOW for all the bag holders Dougie

[CRIXUS @CRIXUSwasHERE]

CORRECT!!🇺🇸🇺🇸🇺🇸😔

[Talkin' Yanks @TalkinYanks]

Carlos Rodon disaster and the Mets lead

[MARK JW 🇬🇧 ⚔🗡 @skidders67]

Here he is 🎶🎶😆 #fridayvibes

[Forever DNA @Forever_DNA]

@TalkinYanks He's flinching big time after every pitch, just watch him.

[Forever DNA @Forever_DNA]

@pawcio2009 Change your name again.. How bout BioSketchy, BioWaffle, BioShaky or BioBunker ? or get creative & come up w something but Surge ain't it right now!

[Bionerd51 @Bionerd51]

$SRPT Ingram can't retire soon enough. They must hire a new CEO from outside the company.

[Forever DNA @Forever_DNA]

Can't wait till DI is out too. That was part of my solution at the time. They all had to go - VP, MM & him, 3 of 3
That may be the only possible thing that will finally lift $SRPT share price out of the quagmire it's been in since then.

[Kar Mac @KmaxtremeKr]

Who would have thought a year ago that Doug Ingram would outlive Marty Makary and Vinay Prasad? $SRPT

[Forever DNA @Forever_DNA]

Podcast/selfie video bro is gone not a day too soon.

[Alexander Gaffney @AlecGaffney]

With FDA's Marty Makary resigning as FDA Commissioner, I wanted to share a few thoughts that I wrote about last night for AgencyIQ. 👇

- Acting Commissioner Kyle Diamantas is likely to remain in the position for quite a while. The logistics of getting a new commissioner confirmed prior to the midterms is daunting, and that's before you consider Senate politics. I can't imagine Bill Cassidy or Josh Hawley making the confirmation process easy for the next commissioner.
- I suspect other officials in an acting capacity, like CBER's Katherine Szarama and CDER's Tracy Beth Hoeg, are likewise going to stick around in their current positions until a new commissioner is named (unless HHS's Chris Klomp steps in, that is).
- I suspect most of the reforms that Makary enacted are likely to stick around, though they will probably be tightened up. There were lots of policies that were great in principle and deeply imperfect in execution and follow-through.
- The big thing to watch is what happens to areas where Makary was leading reforms, but those reforms hadn't yet been announced. Nonprescription drug reforms are a good example: Makary wanted practically everything to be OTC. What happens to that? What about a rule to effectively ban DTC drug advertising?
- What kind of leader is Diamantas? He's been a very effective foods leader (by which I mean focused, on-message, meets with stakeholders, etc). But the move from foods to leadership means he's going to need to handle some tough issues, including an upcoming decision by SCOTUS on mifepristone. He's already a Senior Counselor at HHS, meaning he might need to take a step back from his food portfolio in the coming months and lean more on other senior foods leaders.
- The job of most acting commissioners is simple: Don't make bad headlines, don't rock the boat, and don't piss off stakeholders. That's going to be quite difficult for Diamantas due to the sheer number of issues facing the agency right now. He isn't exactly inheriting a stable agency with lots of experienced, tenured senior leaders. I suspect he's going to lean a lot on HHS Chief Counsel Chris Klomp for assistance and guidance in the coming months, which could include figuring out where he needs to clean house of some ineffective hires by Makary.
- Who will be the next FDA commissioner? With the exception of Scott Gottlieb, Trump has a streak of hiring nonconventional commissioners. Both Stephen Hahn and Makary weren't active in FDA policy circles before they were selected. The question becomes whether Trump decides that was a mistake. It seems like the MAHA wing of Trump's coalition is losing political power, so perhaps we'll see a selection that is more conventional. Because Diamantas is a lawyer and not a medical doctor, I don't think he would have an easy path to Senate confirmation.
- What are the narratives about why Makary left, and what takes hold? At present, there are a lot of stakeholder groups trying to argue that Makary was forced out due to mifepristone/tobacco/rare diseases/pharma/etc. While those arguments tend to do well on X, my best explanation is that Makary just wasn't a good executive in the managerial sense. (1) He didn't come to the job with management experience and wasn't a great manager of people or processes. (2) He frequently got in trouble with senior HHS and White House officials for things that should never have been problems in the first place; (3) His choice of senior executives in his orbit resulted in unrelenting bad headlines and he burned a lot of goodwill and political capital defending them; (4) his management of stakeholder relationships both inside of and outside of the FDA was not particularly good for the bulk of his tenure; and (5) he spent a *lot* of time appearing on podcasts and media, feeding perceptions that he wasn't actively involved in day-to-day management of his agency.
- It seems likely that other senior officials at FDA will leave soon as well. Every FDA Commissioner has legions of senior advisors and executive hires brought in to help fulfill their mission. I don't know exactly who will be leaving, but I would bet that more than a few of them are updating their resumes this evening. I wouldn't expect FDA Chief of Staff Jim Traficant to stay in his position, for example, and Sanjula Jain-Nagpal and Acting Chief Medical Officer Mallika Mundkur might also be on the way out. (Pure speculation on my part, however.)

[Houman David Hemmati, MD, PhD @houmanhemmati]

The FDA Commissioner role is open. This is a pivotal moment for American medicine — & for American patients.

Here’s what I believe the next Commissioner should stand for. Not as a wish list. As a baseline.

🔬 1. BRING BACK THE ADCOMS — AND MAKE THEM COUNT.
Advisory Committee meetings are one of the FDA’s most powerful tools for transparency. They should return in full force. Open. Public. And real.

Patients, doctors, scientists, advocates, & skeptics should all be able to speak. But if you want to speak, you fill out a financial conflict-of-interest form under penalty of perjury — & you read it out loud at the podium before you say another word. Every single person.

And if the issues are complex and the science requires more than one day, then take the time. Don’t cut people off because the schedule says so. The public deserves to see exactly how these decisions are made. Real transparency builds real trust.

⚖️ 2. STOP ASKING ONLY “IS IT SAFE ENOUGH TO APPROVE?” — START ASKING “WHAT HAPPENS IF WE DON’T?”
For rare diseases. For serious conditions with no good options. For patients who don’t have ten years to wait for traditional trials that may never be feasible.

Every regulatory decision carries two risks: the risk of approving something, and the risk of not approving it. Both are real. Both affect real people.

When traditional gold-standard trials aren’t practical, we should still be able to move with urgency — but only when paired with strong post-approval commitments and rigorous safety monitoring. We can give desperate patients a chance without abandoning scientific integrity.

🇺🇸 3. THE FDA’S ONLY CLIENT IS THE AMERICAN PATIENT. FULL STOP.
The FDA exists to serve patients — not outside interests or external pressures of any kind.

It must continue protecting the public from products that carry real, known risks but offer no meaningful clinical benefit.

At the same time, when there is credible evidence that a treatment can help patients with serious conditions, Americans and their physicians should be trusted to make informed decisions once they have complete and honest information about the risks, benefits, and alternatives.

The FDA’s job is to make sure the science is sound and the information is clear. Then let patients and doctors do what’s best for them.

These principles matter because the FDA’s decisions affect every family in this country.

Note: This is a simple social media post and not a massive policy document. The issues are FAR more nuanced, there are challenges and risks with each of the things I said above, and I recognize that. But it's intended to serve as a discussion starter. We must always strive to improve, and we can when we have open debate and dialogue.

[Forever DNA @Forever_DNA]

Politics, not science or medicine will continue on course at FDA. Finally MM & Prasad are out, but a Lawyer to lead @US_FDA ?? is flat out asinine.
It's infuriating, sad, pathetic, a huge missed US leadership opportunity all rolled in one $XBI $IBB ...

https://t.co/z872WwuIHI

[Forever DNA @Forever_DNA]

$XBI I hope they get a great video when they perp walk Makary out of the building.
Then he and Prasad can laugh about it on their next podcast.
Both those guys all talk, no science or action
Scary Q? is who comes next & how bad will they be?

[CP2 @LuckyPenguin10]

MAKARY OUT!

–
$QURE $CLPT $XBI

[Hater Report @HaterReport]

Spurs beating the Timberwolves so bad they just trying things 😂🤣

Devin Vassell jumped BEFORE he even caught the ball and shot a no-dip 3 IN THE AIR

INSANE

[Rep. Jake Auchincloss 🟧 @RepAuchincloss]

🧵Earlier this week, I questioned RFK Jr. on Marty Makary’s incompetent leadership of the FDA. RFK Jr. could not defend Marty Makary. The commissioner needs to be fired. Here’s why:

[Rep. Jake Auchincloss 🟧 @RepAuchincloss]

Scientists under political pressure from Makary have shared their concerns through my office’s whistleblower channel. Here are a few:

"I was pressured into withholding a recommendation for approval for a drug that was intended for a rare disease by Dr. Prasad and other FDA leadership"...

"Direct lobbying to the Commissioner's office [is] a smart and productive business practice for companies to get what they want."

[Forever DNA @Forever_DNA]

& while you're all at it- medical hallelujah meeting, How about fixing all those awful rare Dx mistakes FDA made- $QURE $CAPR $SRPT You're hurting rare disease families every day. Somebody w a lot of views quick phone up trump. Kids & people needlessly dying too soon rfk & makary

[Forever DNA @Forever_DNA]

$XBI $GHRS $CMPS So just like that? Rogan calls Trump, who texts him back & boom- psych FDA approval? While RFK stands there stiff as a board & Makary is just a bad prop. Scientific process, data, AdCom, stnd review, AA or most ridiculously political FDA in history? Unbelievable!

[*Walter Bloomberg @DeItaone]

TRUMP: ANNOUNCING HISTORIC REFORMS TO ACCELERATE ACCESS TO MEDICAL RESEARCH AND TREATMENT BASED ON PSYCHEDELIC DRUGS

[Forever DNA @Forever_DNA]

@KampnerSam That's fake news. Q- When was the last AI blockbuster drug big pharma put out? A-There haven't been any.
Almost all pharma growth is from biotech acquisitions $XBI
Big pharma R & D is a joke using AI or not & it's not moving the needle much at all if any.

[Forever DNA @Forever_DNA]

@Longroaderstar What a joke for a while now
Since RFK Makary & Prasad took over.
They all love to podcast & videos of their nonsense

[Forever DNA @Forever_DNA]

@viatoCEO @DrMakaryFDA But that's what MM knows how to do & likes doing - selfies and podcasts.
Not the actual work of leading FDA & hiring the best staff.
Self-promotion is his gig !