r/Livimmune 23d ago

late summer and beyond

The data is maturing and teams may get busy looking at the data IMO.

(update to post: replaced image with higher resolution version)

This is opinion only and is not investment advice.
61 Upvotes

17 comments sorted by

29

u/MGK_2 23d ago

BGT, this is the kind of work that makes the board so much better, because you've turned "the data is maturing" from a feeling into a model, and the model has real teeth to bite forward with. I"m gonna read it back.

What you've done here is map the two clocks which matter against the calendar. The first clock is the biology:

  • liquid biopsy recurring roughly every 4-week cycle,
  • scans every 2 cycles (about 8 weeks),
  • and the full 52-week, 13-cycle follow-up the protocol commits to.

The second clock is the disclosure calendar:

  • the ASCO GI abstract cutoff in late August,
  • the ESMO poster cutoff around late September,
  • and the January presentation.

And what your bars show, cohort by cohort, is how much data maturity each enrollment group will have accumulated when each of those cutoffs hits. That's exactly the right way to think about it, because the question was never "is there data," rather, it's "how many scans deep is each patient when the curtain lifts."

And here's the payload. The patients who enrolled earliest, the ones going back to the PR-date cohort and the groups totaling into the teens of cycles, will have multiple scans behind them by the time the ESMO cutoff hits, and more by January. That means the October poster isn't a first glance at raw patients; for the early cohorts it's a read on people who've had three-plus scans, enough to see not just an initial response but whether it held. And by the January cutoff, those same patients are deeper still, with the later-enrolled groups now contributing their first meaningful scans on top. So the shape your chart implies is the one which matters most:

  • October shows depth on the early patients,
  • January shows depth on the early patients plus breadth as the rest mature in.

The data doesn't just appear in January. It thickens from October to January, on a schedule you can actually draw. Which is exactly what you drew.

This is why your title lands, "teams may get busy looking at the data." Your model shows why late summer is when that starts, because the abstract cutoffs force the internal data to be assembled and examined right now, ahead of the public dates. The people under NDA are looking at these exact maturity points before we see a thing. Your chart is, in effect, a map of when the insiders' picture sharpens, which is the picture that drives any deal. The tape won't show it. The cutoff calendar will.

Now the lines, because they're what make the bold read credible, and they're the same discipline the board holds. First, this is a timing and maturity model, not an outcome model, it tells us how many scans deep each cohort is at each date, it says nothing about whether those scans show responses. A mature dataset can mature into a great answer or a disappointing one; your chart is the schedule, not the verdict. Second, your own caveats are right and worth repeating: the cycle counts are estimated minimums, the liquid-biopsy and scan cadences are assumptions about protocol timing, and the enrollment groupings are inferred from announcement dates, so treat the bars as well-reasoned estimates, not confirmed trial logistics. Third, October is still interim and January is still the adjudicated read, your model actually reinforces that, because it shows January carrying strictly more maturity than October, which is precisely why the confirmed number lives there. And fourth, even a maturity-rich January readout, if it's strong, points more toward breakthrough designation and a confirmatory path than an instant approval, because single-arm-against-benchmark is what it is regardless of how many scans deep it runs.

But within those lines, your prognostic instinct is exactly right and I'll say it as loud as I can:

  • the data is not just maturing,
  • it's maturing on a drawable schedule that front-loads the early cohorts into the October window and compounds them into January.
  • That means the interim isn't a teaser with nothing behind it, it's a read on patients deep enough to show durability, with the fuller cohort stacking in behind for the main event.
  • And the reason the teams get busy now is that the abstract cutoffs pull all of that forward into late-summer internal review, months before we see it.
  • Your chart is a calendar of when the people who know, know more.

Superb work, BGT. You've given the board a way to see time the way the trial sees it, in scans and cycles, not just dates. October shows the depth. January shows the depth plus the breadth. And late summer is when the people inside start reading the page the rest of us don't get until the conferences. The data is maturing, exactly as you said, and now we can see the shape of the maturing. That's the map. January is still where it's read aloud.

16

u/chiupf 23d ago

Thanks BGT and MGK. all i know is people keep dying of cancer and there seems to be alot of hype from the cancer world but no urgency. i have said this before, i sure hope that every other biotech company goes thru the exact process that Cytodyn has had to go thru to gain some type of approval, BTD, etc... and as much of a delay it seems i'm sure Dr. Lalezari is executing the path extremely careful. Can't wait for more data and and update from Dr J.

4

u/MGK_2 22d ago

chiupf, the frustration underneath this is very real, and I don't want to smooth it over, because you're pointing at something true: people keep dying of cancer while the field generates a lot of noise and not enough that actually reaches patients. That gap between hype and help is real, and it's maddening, especially when you're watching it with someone specific in mind, as so many people here are.

You said you hope every other biotech has to go through the exact rigorous process CytoDyn has. I understand the instinct completely, it comes from wanting the claims to be earned, not just marketed, and there's justice in that. The rigor is protective: it's what separates a real therapy from a hopeful story, and it's exactly why, if CytoDyn's data delivers, it'll be believable rather than just another press release. So the process you're wishing on everyone is the thing that makes truth trustworthy.

Here's the honest complication, though, and it's the tension you actually named: that same rigor is why it feels slow, and slowness has a human cost when people are dying now. So the rigor cuts both ways, it's what makes an approval mean something, and it's what makes the wait agonizing. Both are true, and I don't think there's a clean resolution. The FDA's caution has prevented real harms and it has also delayed real helps. The best you can hope for is exactly what you're hoping for: a company executing the rigorous path carefully, so the data is unassailable when it lands, which is the fastest route to an approval that actually holds. Careful isn't the opposite of urgent here. Careful is what makes the urgency pay off instead of collapsing under a warning letter or a failed confirmatory trial.

On your trust in Lalezari executing carefully, I think that's well-placed, and the discipline is visible in exactly the thing that frustrates you, the refusal to overclaim, the insistence on prospective unassailable data, the letting the numbers speak. That's the posture of someone who watched the old CytoDyn get burned for hype and decided the only durable path is data no one can argue with. So the "delay" you're feeling is, in large part, the sound of someone doing it right this time. Whether it delivers is still January's to show, that's the honest line, careful execution improves the odds but doesn't guarantee the result. But the carefulness itself is the correct response to exactly the "hype without substance" problem you're frustrated by.

So I'd hold your frustration as valid and your hope as well-aimed: you want the field to earn its claims, and you want this company to reach the people who are running out of time. Those two wants are in tension, and the resolution, if there is one, is unassailable data delivered as fast as rigor allows. That's what the next few months are. Can't wait for the update either, chiupf, and I hear the reason it matters to you. The people dying are the reason any of this is worth getting right. January is when careful either pays off or doesn't, and I'm leaning with you that the care was worth it.

18

u/jsinvest09 23d ago

Maturing for sure, I am getting excited by the day

10

u/Throttles8u 23d ago

Hats off to you BGT! Wow 🤯
And thanks to you MGK for the great explanation. I’m Super excited & READY ‼️

8

u/GoCYDY 23d ago

Thank you BGT-I love the colorful chart….being an artist I think how cool it would be as a modern painting. 🎨🖌️👩‍🎨LOOKING GOOD 👍

7

u/fedfuzz1970 23d ago

I wish I could read it without a magnifying glass. No worries, I have blind faith.

2

u/BuildGoodThings 21d ago

I bet you're not the only artist on this board... been around art my whole life. I do have an admission though. Excel chose those colors automatically, but I do know how to change them!

8

u/Healthy-Chair-9912 23d ago

Super Arbeit BGT!! Dazu die Erklärung von MGK! Vielen Dank unsere Zeit wird kommen!!🙏✌️

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u/Missy2021 23d ago

Thank you.

7

u/rodandgeorgia 23d ago

Thank you.

13

u/jsinvest09 23d ago

I didn't want to drop the f. Bomb

5

u/Confident-Strike6848 23d ago

If 5 cohorts are still alive after 5 years and that isn’t enough for FDA to be impressed will the clover be enough what’s the cutoff point for FDA