Arie Blitz

Retired Cardiac Surgeon, Healthcare Investor/Trader

[Arie Blitz @BioPharmTrader]

@biobucksnews BD

[Arie Blitz @BioPharmTrader]

@MelGibsonEv Her

[Arie Blitz @BioPharmTrader]

It is going to be quite a morning. $DFTX $CRBP $CGEM $SMMT $SRRK

[Persimmon Tree Investments @PersimmonTI]

$XBI

Should be a 🌶️ morning tomorrow:

$DFTX — Topline Results from Phase 3 Panorama Study in Generalized Anxiety Disorder.

$CRBP — Conference Call to Discuss Topline Data from CANYON-1 Clinical Trial and the Potential of CRB-913 In Obesity

$CGEM — Virtual Analyst and Investor Event to Showcase Zipalertinib Plus Chemotherapy Phase 3 REZILIENT3 Data

$SMMT — full data re: ivonescimab OS win

[Arie Blitz @BioPharmTrader]

@SheffStation Great call, Sheff!

[Arie Blitz @BioPharmTrader]

@WassimLaroussi3 Looks good to me. No surprises.

[Arie Blitz @BioPharmTrader]

@ariel_oseran Who is admonishing whom?

[PDUFA Pulse @PDUFA_Pulse]

The cleanest $CELC question is not “approval odds.”

It is what the Day 0 label lets investors believe.

Watch:
-population language
-prior therapy / line setting
-combo framing
-safety / tolerability language
-any wording that limits the commercial imagination

The FDA decision is first. The label read is the trade.

[Arie Blitz @BioPharmTrader]

The FDA deserves credit for revisiting decisions made under an overly rigid view of evidence. Placebo-controlled trials are often the best way to answer a medical question. But in a rare, fatal disease affecting a small number of boys, the best trial design in a statistics lecture may be the wrong one at the bedside.

This is not an argument for lower standards. It is an argument for standards that can recognize circumstance. If the disease is devastating, the biology plausible, the untreated course predictable and the patient population tiny, FDA should be able to consider evidence short of a placebo trial while still requiring serious follow-up.

The troubling part is that these life-or-death judgments have seemed too dependent on who is running the agency. That is bad for patients, bad for physicians and bad for biotech companies trying to understand the rules.

If the current FDA is willing to restore some consistency, it deserves praise. Patients are not a distraction from the agency’s mission. They are the mission.

[Jason Mast @Jasonmmast]

It is striking how quickly new FDA leaders are walking back decisions made under Prasad, Makary, and Hoeg

$RGNX

[Arie Blitz @BioPharmTrader]

@Sofia50020Sofia Skin...that used to be a Trivial Pursuit question way before your time :)

[Arie Blitz @BioPharmTrader]

@YieldMaxETFs @ambofqwan Are you planning on having a biotech/pharma Yieldmax ETF?

[Arie Blitz @BioPharmTrader]

@YieldMaxETFs When are you going to add a Yieldmax ETF covering the pharma/biotech sector? @Michael_Khouw

[Arie Blitz @BioPharmTrader]

@SheffStation Now bolting up to 120%. Great job, @SheffStation

[Arie Blitz @BioPharmTrader]

Biotech Trading Prep for Back-to-Back Conferences

[Arie Blitz @BioPharmTrader]

Hi @emportop, could you please add uncy to https://t.co/F4J0pfI6lD? Thanks!

[Arie Blitz @BioPharmTrader]

If you know, you know :)

[Arie Blitz @BioPharmTrader]

Trader Beware!

[Adam Feuerstein ✡️ @adamfeuerstein]

The #ASCO26 abstracts will be posted tomorrow at 5 pm EDT. What this means, and what is doesn't.

-- No late-breaker abstracts tomorrow. You will not see the plenary session data from $RVMD, Akeso / $SMMT, $JNJ or $LLY. If you're eager to see any LBA data, you'll need to wait for the actual meeting.

-- All regular abstracts will be posted tomorrow night. This can be confusing and frustrating...

-- Per ASCO rules, companies can report ALL their data tomorrow evening via press release, even if the abstract only contains old data. Some companies will choose this route.

-- BUT, companies choosing to report full data tomorrow via press releases cannot show data slides or posters. Those must be withheld until the actual meeting.

-- Some companies may choose to only show abstracts tomorrow, and wait for the meeting to present new/updated data.

Personally, I hate this system. If I made the rules, I would reserve all full/updated data for the actual meeting.

Good luck tomorrow. Happy #ASCO26 abstract release night for all who observe.

[Arie Blitz @BioPharmTrader]

@WassimLaroussi3 BTW, as a physician, I think you are doing an outstanding job with timely posts and summaries. Congrats.

[Arie Blitz @BioPharmTrader]

@WassimLaroussi3 Thx!

[Arie Blitz @BioPharmTrader]

Very impressive start.

[Alpha Tau Medical @AlphaTauMedical]

Alpha Tau Announces Groundbreaking Interim Results from its U.S. Alpha DaRT® Recurrent Glioblastoma Trial, with 100% Local Disease Control, 67% Complete Response Rate, and Favorable Safety Profile Observed - Conference Call Scheduled for 8:30am ET
https://t.co/cxKBX7Fniw