Call a friend Grok

Struggling to be away from twitter & yet to succeed.

[Call a friend Grok @runlolarn]

Nice line. It echoes the old maxim 'ex nudo pacto non oritur actio',
a bare promise binds no one;
without consideration there is no contract.
The difference here is that the second hand is offered with quiet confidence that something may yet flow the other way and if not so what.

[Call a friend Grok @runlolarn]

@Biotech2k1 @jfais20 In hindsight, it is clear that you have many well-wishers. Good to know that you are also accessible through DMs in case of any exigency.

In the process, I followed Jonathan. As the saying goes, surround yourself with experts.

[Call a friend Grok @runlolarn]

I only started following your posts from today. Before commenting further as I see your both bio and tech symbols, one thought comes to mind from book 'The ONE Thing' by Gary and Jay “If you chase two rabbits, you will not catch either one." Thanks for sharing so many symbols. Will revert more. Thank you thank you.https://t.co/R3tBCUfFjG @kejca

[Kevin Carpenter @kejca]

Charlie Munger: "It's not a competency if you don't know the edge of it. You are a disaster if you don't know the edge of your own competency."

"Warren [Buffett] frequently says, 'I'd rather deal with a guy with an IQ of 130 who thinks it's 125 than a guy with an IQ of 180 who thinks it's 200. That second guy will kill you.'"

"Warren and I know the edge of our competency better than other people do. That is a very important thing to know."

(Caltech || 2008)

[Call a friend Grok @runlolarn]

@skeptical_bob Thanks. Intemperate temperance defeats the cause of temperance.

[Call a friend Grok @runlolarn]

$Capr .
FDA staff admitted at adcom that they never warned Capricor during Type A meetings that they were holding them strictly to early draft SAP 1.1.
So key takeaways are:
The Catch-22: Capricor updated to SAP 3.0 before unblinding per ICH E9 rules, but FDA treated silence as non-approval and defaulted back to 1.1 which was never submitted for approval but was a initial rough draft. ( It reminds me the chapter of book of Richard Carlson. Never sweat with bureaucracy. Globally in all countries by and large they have same psychology. I am ok you are not ok. )
The Real Dispute: It was never about whether the upper-limb signal ($p = 0.029$) is real.
it was a bureaucratic battle over which statistical rulebook applied.
The Pivot: This exact procedural breakdown is why CBER leadership (Peter Marks) retains full executive authority to grant regulatory flexibility on August 22.

[Reads with Ravi @readswithravi]

Who is that one author you buy even without reading the book description?

[Call a friend Grok @runlolarn]

The ⁠FDA relied on an outdated, unsigned analysis plan, Capricor CEO Linda Marbán said, arguing that it "pigeonholed the whole meeting into a discussion of which stat plan was right, which imputation model was right and how the data should be looked at for one or ​two patients."
Marbán said that ​focus ignored the ⁠totality of the evidence and the impact on people with DMD and their families.
Cantor Fitzgerald analyst Kristen Kluska said the FDA staff ​hosting the meeting seemed "extremely negative during the entire conversation and ​were going ⁠into this meeting with the mindset to reject the application".
https://t.co/34JpmuUd7H
Having shared that:
Strong pushback from $CAPR CEO Linda Marbán and Cantor Fitzgerald’s Kristen Kluska on the FDA’s AdCom stance. Hard to ignore how adversarial the briefing docs were, focusing on an outdated SAP draft rather than the final dataset.
Technical biostatistics shouldn't obscure real patient benefit.

[Call a friend Grok @runlolarn]

Incredible forensic work. It’s rare to find an analysis that holds both the FDA and the sponsor accountable to the raw primary sources without taking a cheerleader or short-seller stance.

Really appreciate you laying out the historical precedent with ELEVIDYS and CBER executive discretion. Definitely following along for more of your breakdowns leading up to PDUFA.

[Call a friend Grok @runlolarn]

The narrative surrounding Adcom meeting requires a closer look at how the session was structured. The formal ballot question was restricted strictly to cardiomyopathy.
Meanwhile, upper-limb skeletal preservation (PUL 2.0) was kept as a non-voting discussion topic, where panel clinicians expressed clear, qualitative support for the signal. Under the rank-transformation model (SAP v3.0), which has now been peer-reviewed and published in The Lancet, deramiocel demonstrated a statistically significant 54% slowing of upper-limb functional decline ($p = 0.029$).
While internal FDA review teams focused heavily on baseline protocol math (SAP v1.1 vs. v3.0) for the cardiac claims, isolating the ballot question this way leaves a clear administrative opening.
It provides CBER leadership with the exact clinical justification needed to consider a narrowed, upper-limb label for non-ambulatory Duchenne patients ahead of the August 22 PDUFA target date. $CAPR @adamfeuerstein @Capricor, @CureDuchenne, @ParentProjectMD , @defeatduchenne , @Biotech_Beast

[Call a friend Grok @runlolarn]

@theliverdoc sturgeon law.

[Call a friend Grok @runlolarn]

@ParvejKhan2009 @theliverdoc I won’t get liver disease as he has educated us else I m simply to fly to Cochin.
It’s other matter,in Canada, sturgeon law in hospital is slightly less than in India. Beware though that is universal in all areas of life.
Stay surrounded by 5 pc as author Rolf Dobelli concludes.

[Call a friend Grok @runlolarn]

@iArpitSpeaks On a lighter note, I guess many of us in India are accidental professionals. Your profile reminded me that, as a fellow CA, I can still console myself that I'm at least a little above average.

[Call a friend Grok @runlolarn]

@theliverdoc Rolf Dobelii went off line before starting his second book ‘Art of good life’ Both including art of thinking clearly are master pieces.He does not even read news.
Best of luck.

[Call a friend Grok @runlolarn]

@theliverdoc It is said that only a rare few lead and uplift India, you are one of those remarkable souls. Your followers are proud of you, and your parents must feel truly blessed.

[Call a friend Grok @runlolarn]

@dr_ericberg I think all MDs should start advising on your profession and write at end of tweet like you write ‘Not chiropractor.’ @theliverdoc has with clinical studies have adviced u in u tubes against what u tweet.
I wish you would have told your followers how wrong you are in tweets.

[Call a friend Grok @runlolarn]

@TheHWChannel @Sonal_MK At sometime you should also be interviewed. Liked your not starting sugar to the little one till age 5.
2. About Anoop You know perversity of human nature is to make simple things difficult. Hum ney chahiye me already allowed 1sugar spoon.
imokurnotok. CGM guides me to eat all.

[Call a friend Grok @runlolarn]

@dr_ericberg You are so against studies.Guys just ask AI.
Atleast Instead say Decaf (or mix) would give most liver benefits from polyphenols without caffeine crashes/tolerance. Not as strong as regular coffee for liver benefits. @theliverdoc please intervene.

[Call a friend Grok @runlolarn]

@theliverdoc 2/2 Grok ‘Authoritative sources including WHO, US Surgeon General, and World Cancer Research Fund confirm alcohol is a Group 1 carcinogen that increases risk for at least seven cancers (breast, colorectal, esophageal, liver, oral, pharyngeal, laryngeal) even at low intake levels’

[Call a friend Grok @runlolarn]

@theliverdoc What a service to humanity by writing quote with core of heart.
Thank you Dr Abby.
I forwarded it to my formal dear ones too who drink.
Health (as it is emergency) is an exception to the saying {Temperate temperance is good,intemperate temperance defeats the cause of temperance.}

[Call a friend Grok @runlolarn]

@glucosegoddesss How you would rate the new inventions in pipeline not reducing your appetite but different mechanism to obesity vis a vis glucose revolution book.
Which are CRB-913(Corbus) and Mitochondrial Uncouplers (BAM15 and HU6 or triple action of ei Lilly.