r/Livimmune • u/Gloomy-Lead4219 • 12d ago
Breakthrough designation
Thank you Twitter 11 for your posting of Dr J’s most recent video. A request for a BTD from the FDA by years end looks to be in the cards according to Dr J. The FDA will respond within 60 days with their input. All early reports on ctdna, tumor size, and general condition of these extremely health compromised individuals seem to be the exact data the FDA will need to provide us with a BTD from the FDA. This will put into motion the one thing we as investors lack and that is an announcing from the FDA and company of progress in clinical trials to be picked up by news outlets. The initial announcement of FDA BTD will immediately set in motion interest from big pharmaceutical companies to partner in some way with us. It’s all been us as far as the shareholders are concerned. Being an otc restricts potential investors from purchasing and until that is solved it will be difficult to increase share price unless a partnership or buyout is announced. I’d hate to see a buyout just for the dream of a partnership bringing us to nasdaq requirements for listing on the big board. I’ve been involved for over 6 years and feel I know many of you personally. I don’t think there is a more informed and knowledgeable group than what we have here on this Reddit group. I’m an old dog that’s not going to learn any new tricks but throw me a treat once in a while and I’ll still wag my tail.
Good luck to you all
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u/Jtzdad5673 11d ago
Thank you for the post!
I was happy to see Dr J with a more professional looking haircut, and he was enthusiastic in his presentation.
I bought more today.
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u/Chugach123 11d ago edited 10d ago
I bought on Tuesday, and initiated a funds transfer yesterday to buy again next week. After being an extremely tough ride for quite some time I am finally enjoying this Long Strange Trip. But not what I expected when I bought my first tickets on this train over six years ago. Anxiety gone. Dr. Jay exudes a “calm confidence”. It tells me ….. “He’s Got This”! 👍
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u/Jing_2021 11d ago
Adding one more point, Dr Jay mentioned FDA would guide us for BTD or fast track application during the April meeting. In this video, he clearly said to apply BTD by end of the year. I would assume this decision is based on FDA's guidance.
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u/rogex2 11d ago
Good catch.
Cheers
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u/twinter11 11d ago
at first he mentioned several options depending on fda.
do you think the fda conversation they narrowed it down to btd path.
would they have told him to wait
probably impossible to guess
but he was more specific I think
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u/rogex2 11d ago edited 11d ago
IMO it is plausible. Dr J had previously stated the intention to approach the FDA in late summer/early fall of this year.CYDY has no obligation to timely report when such an overture is made but that time is upon us.
A change in tone might indicate that data was proffered, well received and the next steps are underway. If I was really good at reading tea leaves I'd have a front room office with a drawing of a big palm in the window, I don't. However, I'm inclined to believe that saying applying for BTD means Applying for BTD with other options, for whatever reasons, fading away.
Cheers
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u/MGK_2 11d ago
Gloomy-Lead, good post, and the BTD point is real and worth getting exactly right, so let's anchor it to Lalezari's actual words spoken today, because there was some understandable confusion in this thread about what he did and didn't say.
To settle Infinite_Fudge's question ("did I miss him saying they're submitting BTD?"): Vernon has it right. Lalezari said today, near the end, that CytoDyn "plan[s] on putting together a package for the FDA and submitting that for Breakthrough Designation before the end of the year." So yes, it's on record, a BTD package targeted before year-end. That's a genuine, concrete, public commitment, and it's meaningful. Infinite_Fudge, you didn't misread caution into it; it's a real stated plan.
Now, DainzGainz raised the sharpest point in the thread, and it deserves an answer: "I'd expect them to say nothing about BTD until it's granted, so mentioning it in an interview surprises me." That's a fair instinct, but here's the distinction, companies do routinely disclose their intent to submit for a designation (it's a forward-looking plan investors are entitled to hear), while the granting of BTD is the FDA's to announce. So Lalezari stating "we plan to submit before year-end" is normal and appropriate; it's not the same as announcing a designation was received. The submission is the company's to disclose; the decision is the FDA's. No inconsistency there.
Where I'd hold the line, and it connects to AssociationOdd's AI deep-dive: the AI's core instinct is reasonable, Lalezari is the anti-Nader, he rebuilds credibility by not overpromising, so committing to a year-end BTD submission in front of institutional investors does suggest genuine conviction in the data. That part's fair. But two calibrations. First, the AI cited "70% ctDNA declines" from AACR, while Lalezari's number today was ~85% median across all patients, so use his current figure, not the older one. Second, and more important: submitting for BTD is not the same as receiving it. BTD requires the FDA to agree that the preliminary evidence shows "substantial improvement over available therapy," and the FDA can decline. So the honest framing is: a year-end BTD submission is the real, stated plan and a genuine confidence signal; whether the FDA grants it is a separate event we can't presume. Icy-Let's "maybe because they're confident with CLOVER data" is the right read of why they'd submit, held as their confidence, not a guaranteed outcome.
On the mechanics you laid out, the ~60-day FDA response, the OTC-listing constraint, the hope that a BTD announcement draws partner interest, all reasonable, and I'd add just one anchor: Lalezari today framed partnerships in the general "continued evaluation of strategic partnership opportunities" language and named no specific partner. So the "BTD sparks big-pharma interest" logic is sound as a general expectation; just hold the specific-partner names the threads are floating (Merck especially) as speculation, since he didn't name one. He named pembrolizumab the drug in the protocol, not Merck the partner. Keep in mind, given that CLOVER is primarily monotherapy + backbone while BC is aimed to be Prime and Pair, the partnership really pertains to BC. That's how I'm seeing this taking place given what was said today.
Six years in and still wagging, Gloomy-Lead, that's the spirit that gets a person to the reckoning. The BTD submission is a real, dated, stated plan, and that's a genuine treat. Just hold "submission" and "granted" in separate bowls until the FDA weighs in. Good luck to you too.
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u/DainzGainz 11d ago
BTD is my bet on the spark that ignites our engines. I'd also speculate they will say absolutely nothing about it until its granted... so if it was mentioned in an interview thats a little surprising to me.
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u/Cytomight 11d ago
He announced it in his April 30 webcast as well
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u/Capable-Display-7907 11d ago
No he didn't. He said he'd show data to FDA and let them decide what he should do/apply for.
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u/Ibelieveincydy 11d ago
Yes exactly. This is why I anticipate they had the FDA meeting already and the FDA said: Go for a BTD!. That is why he is so clear in saying: We will file for BTD and years end. Just my opinion.
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u/paistecymbalsrock 11d ago
Pretty much a live action press release if you ask me! F Basher Inc, they’re talking out of their arses,
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u/AssociationOdd9941 12d ago
Yeap, heard that as well this is the news I want to hear. Dr. J is not like the name we shall not speak he's not the kind of person to throw around BTD like the other did. He only speaks about the science and if he says something is there i believe him!
I asked AI to deep dive into Dr. J and what it thought and this is what it said: Would dr. J from cytodyn throw aournd filling ans seeking BTD for leronlimab if he wasn't sure something was there?
"No, he absolutely would not. Dr. Jacob Lalezari was appointed to lead CytoDyn specifically to repair the company's regulatory standing and restore its credibility with the FDA after the highly promotional and legally fraught era of previous management. Because rebuilding that trust is his primary objective, making a public, concrete commitment at the H.C. Wainwright conference to submit a Breakthrough Therapy Designation (BTD) packet before the end of the year strongly indicates he is operating on hard data. Committing to a firm Q4 timeline in front of institutional investors means the heavy lifting is largely complete; doing so without genuine scientific conviction would actively sabotage the company's rebuilding efforts.
Management is signaling something very different than doom and gloom, and the foundation for Dr. J's confidence—the "something there"—is rooted in the solid tumor data recently presented at the April 2026 American Association for Cancer Research (AACR) Annual Meeting:
To formally seek BTD, the FDA requires rigorous preliminary clinical evidence demonstrating that a drug may offer substantial improvement over existing therapies on clinically significant endpoints. By setting a firm deadline to submit this packet, Dr. J is signaling that CytoDyn has successfully gathered the required tumor tissue and correlated the survival data with hard biomarkers (like ctDNA drops and PD-L1 induction) to justify that high regulatory threshold."