GastroMIND

Gastroenterology Business Development Specialists

[Adam Feuerstein ✡️ @adamfeuerstein]

I spoke with Caribou $CRBU CEO Rachel Haurwitz last night about the gut-wrenching decision to shut down after failing to raise money to move its off-the-shelf CAR-T for lymphoma into a Phase 3 study.

“Biotech companies close all the time, usually because the idea didn’t work, or the drug didn’t work. So, you wind down. You learned something, and you move on,” Haurwitz said.

“Our experience is incredibly disappointing. Our clinical signal is strong. The benefit to patients is compelling and commercial research shows the drug could be market-leading. But all of that isn’t enough in this fundraising environment to get over the hurdle to raise enough capital,” she added.

https://t.co/HSR1BNQUPw

[Adam Feuerstein ✡️ @adamfeuerstein]

Why do drug makers (biotech, pharma) issue press releases on the outcomes of clinical trials before publication and without including substantive data?

This is a question — more often a complaint — I see a lot. Merck and Moderna with the mRNA cancer “vaccine” and Novartis with the lp(a) study are recent examples. Let me try to explain:

1. These are publicly traded companies, regulated by the SEC. As such, they are required to promptly disclose information to shareholders and the public that is “material” to the business. Bottom line: “Oh shit” news — good and bad — that affects the company and the stock price needs to be publicly disclosed quickly. Management cant sit on it. (And yes, there are exceptions to all rules.)

2. The amount of information about study outcomes disclosed in press releases varies. It’s frustrating when a company says, “Drug X achieved the primary endpoint” without disclosing numbers. Why is this done? Often, it’s to preserve data for presentation at a medical meeting.

Cardiology meetings like ACC and ESC, for instance, have strict rules. If you announce data in a press release, you can’t present at their meetings. Cancer meetings like ASCO are also strict. Once upon a time, even a bland press release would violate medical meetings disclosure rules. It took awhile before they understood drug makers have SEC regulations that must be followed.

3. Study papers in journals take time to compile, write, submit, go through peer review and the get published, etc. Do you really want to wait that long to know how a drug study turned out?

4. Thankfully, the dissemination of study results, like life, is ruled by compromise. In my experience, a majority of press releases announcing material study results contain some top-line data, enough to quantify the outcome. We may have to wait for a medical meeting months later for important details, but the press release gives us enough data to answer basic questions.

5. Who decides which data to disclose promptly and which to withhold for later? The lawyers, of course. Always the lawyers. But also, company scientists and management. It depends on type of study, the indication, potential competition and the venue (medical meetings) where data will be later presented. At a minimum, you like to see data on the primary endpoint, maybe a key secondary endpoint(s) and safety. Rules vary. The rules work and they can also be abused. Some companies are transparent and honest, others not so much. Like life.

5A. I would prefer even a tiny sliver of data in a press release over no data at all. I think we all would. But when the latter happens, there are usually legit reasons for it that go beyond, “[Drug company] is hiding or misleading…”

6. It’s not a perfect system, but in my experience it works well enough to satisfy investors and scientists.

7. If you’ve read all the way down here, thank you! I now welcome all your comments about why I’m an idiot and wrong. 😑

[S A I ™️ @WallStSai]

$LLY Eli Lilly bought 7 companies within last 5 months. $20 billion+ spent since January.

Look at what they actually bought:

Circular RNA platforms
Non-viral DNA delivery systems
Lipid nanoparticle technology
Sleep therapeutics
Gene delivery infrastructure

They're buying the delivery system for the next generation of medicine.

Revenue-gap buyers grab late-stage assets with near-term cash flow. Platform builders buy preclinical technology nobody else values yet.
Lilly is doing the second thing.

What will they acquire next ??

$XBI $MDGL $ABVX $NVO $VKTX

Source: Natasha Pomelova

[ANMS @ANMSociety]

A culmination of a lifetime of work from experts Drs. Satish Rao, Henry Parkman, and Richard McCallum.

[Ian Kremer @LEAD_Coalition]

Woman with #dementia adored her haircut. Her husband's letter to the stylist is everything. https://t.co/e9f1Z6ifVT

#Alzheimers #kindness

[Eric Feigl-Ding @DrEricDing]

7) Yes I care because I was born in China — but also because I’m an epidemiologist (my D degree is in it), & I’ve seen this shit show before. What happens in China doesn’t stay in 🇨🇳— Wuhan was our lesson 3 years ago. The global fallout of this 2022-2023 wave will not be small.👇

[Eric Feigl-Ding @DrEricDing]

6) Westerns think there is a fever and antibiotic shortage now? ➡️Wait until China’s production is diverted from exports! Here—people rushed to a pharmaceutical factory to buy ibuprofen because it is completely sold out elsewhere! Dec 18, in #Zhuhai City.

[Eric Feigl-Ding @DrEricDing]

5) Example—cremation in Beijing nonstop. Morgues are overloaded. Refrigerated containers needed. 24/7 funerals. 2000 bodies backlogged for cremations. Sound familiar? It is spring 2020 all over again— but this time for China, emulating more Western-mass infection approach. 🤦🏻‍♂️

[Eric Feigl-Ding @DrEricDing]

4) The deaths in mainland China is being hugely underreported outside of 🇨🇳. Through a survey of hospitals, funeral parlors & related funeral industry chains in Beijing—there is a recent explosion in funeral services caused by the sharp increase in deaths.
https://t.co/zm1rxeDUoJ

[Eric Feigl-Ding @DrEricDing]

3) Doubling time in China may not be days anymore. Doubling time now possibly “hours” says some experts — let that sink in. R is hard to calculate if doubling is <1 day because it’s hard to PCR test that fast. The point is 🇨🇳 & the 🌎 is in deep trouble.
https://t.co/TcIIHnGZ3k

[Eric Feigl-Ding @DrEricDing]

2) Summary of #CCP's current #COVID goal: “Let whoever needs to be infected infected, let whoever needs to die die. Early infections, early deaths, early peak, early resumption of production.” @jenniferzeng97

Dead bodies piled up in NE China in 1 night—

[Eric Feigl-Ding @DrEricDing]

⚠️THERMONUCLEAR BAD—Hospitals completely overwhelmed in China ever since restrictions dropped. Epidemiologist estimate >60% of 🇨🇳 & 10% of Earth’s population likely infected over next 90 days. Deaths likely in the millions—plural. This is just the start—🧵

[Guy Adami @GuyAdami]

Pretty much sums up where we are as a society..

[Albert Bourla @AlbertBourla]

I have tested positive for COVID. I’m feeling well & symptom free. I’ve not had the new bivalent booster yet, as I was following CDC guidelines to wait 3 months since my previous COVID case which was back in mid-August. While we’ve made great progress, the virus is still with us.

[Gastroenterology @AGA_Gastro]

#ICYMI THE NEW GASTROENTEROLOGIST's overview of therapeutic management of #NAFLD https://t.co/UM4jXwaJ8E

[TheStreet @TheStreet]

Joe Biden was asked if student loan forgiveness was unfair to those who already paid off their loans

Here was his response 👇
https://t.co/d2THdTk8xz

[Liz Szabo @LizSzabo]

Do covid reinfections increase your risk? “We just don’t know the consequences of cumulative hits” from the virus,” said @EricTopol of @ScrippsResearch. #LongCovid @khnews https://t.co/lx17wFgjTI

[GastroMIND @Gastromind1]

@SaraNayeem Great suggestions. I admit to making some of those mistakes. Clear communication is key especially with new MOA.

[Gastroenterology @AGA_Gastro]

Management of gastroparesis in 2022 https://t.co/1pnApfsHOW

[GutMicrobiota Health @GMFHx]

Is the future of medicine related to the quality of our microbiota? This review article updates the therapeutic potential of targeting the human microbiome in a wide range of disorders beyond the gut https://t.co/jqdYPN2IZ0