u/Early-Blueberry838

closing over $9. 🙌🙌

🙏🙏🙏🙏🙏

This is an extraordinarily significant document — and the timing is not coincidental. This was published today, 22 June 2026, on the FDA's official website. It is part of Operation TrialBlazer, a formal HHS initiative. This is not a speech or a press release — it is official FDA policy guidance published today.

Why this matters for IBRX specifically.

The single most important sentence.

Under "Late-Stage Trial Actions," the FDA has today published a revised draft guidance titled "Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products." The key language:

"FDA revised this guidance to clarify circumstances in which drug developers may be able to rely on one rigorous, adequate and well-controlled pivotal clinical investigation, plus confirmatory evidence, to demonstrate substantial evidence of effectiveness for drug approval. The guidance recognises that advances in our understanding of biological processes and the increasing availability of high-quality data have transformed the evidentiary landscape for drug development." sec

The FDA has today, 22 June 2026, published official guidance explicitly saying that one pivotal trial plus confirmatory evidence may be sufficient for approval.

The broader Operation TrialBlazer context

The FDA is eliminating unnecessary regulatory burden, clarifying phase-appropriate requirements, and building partnerships with government, academic medical centres and the private sector. sec

In June 2026, the FDA released draft guidance for companies developing cutting-edge cell and gene therapies, clarifying how companies can build on prior findings rather than repeating costly studies from scratch. sec

The Regenxbio reversal this morning and this FDA page published today are part of the same coordinated initiative — Operation TrialBlazer — announced simultaneously. This is a systemic regulatory shift, not a one-off decision for one company.

does that mean they are filing paperwork with SEC to relist in Nasdaq?

ASAP. A ramshackle house in Luton and a post box in Santo Domingo ?

some off-white funds from Central Asia? Russia? both rich in natural resources.

🙏

something similar is needed for Cats and Dogs. I don’t care about the cost.

as one of the monumental achievements. concurring cancer. if that is true, I expect approval momentarily.

and they should. help as many patients as possible as you trundle through your bureaucracy.

this is all you need to know today.

there have been few times in the recent past where they APPROVED THE APPLICATION IN AS LITTLE AS 44 DAYS. so shorts might bank on 6 months but that would be a dangerous and devastating decision.

85% of the 64,000 cases in the US. 54,400 patients yearly.

per FINTEL. JUST LEAVING IT HERE.

to fire up the Nk and T-Cells?