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If gps is actually is in fact prolonging life this is going to so fuking big.
According to the doctors running the trial on R&D day said BAT 8 months or less and last patient was enrolled 27 months ago now. Give or take that’s about 8/27 =0.296
If hr is that, Jesus bless us all, for u know parents and investors deserve this..
There’s a lot of fud since the stock reached $7 and now way way more fud. In my opinion, it’s worthy of a hold if u was buying in the 1s 2s 3s and loaded in options, hold to the end. U all deserve it

Hi, thank you for your kind words.
People are being rude because there is a cult like following around this stock, and everyone sees it as their ticket to financial independence. To be clear, I am not a biostatistician or a seasoned biotech expert. I just pointed out some major red flags surrounding this company moving away from the biology, especially since I used to be a hyper bull myself until the cracks became too big to ignore.
As far as your study is concerned, it might share the most similar population to the control arm in REGAL, but I do not believe the control arm will mirror that study's performance. The study is more than a decade old, and Best Available Therapy (BAT) has definitely improved since then. Furthermore, my biggest red flag regarding why this stock will fail has almost nothing to do with the biology itself. If you are interested in hearing more about it, feel free to DM me.

AI but still valid: While QUAZAR AML-001 was a CR1 maintenance trial, it provides the definitive biological proof of concept that shatters your 'you must have a transplant to survive 3 years' narrative.
In QUAZAR, older, strictly transplant-ineligible patients on oral azacitidine maintenance hit a median overall survival of **24.7 months**, and a massive **37.4% of those non-transplanted patients cruised straight past the 3-year mark**.
When you move to the REGAL CR2 setting—where patients have already proven themselves to be elite biological responders by forcing a relapse back into a clean remission—and you give investigators the freedom to use even more potent modern maintenance combinations like Venetoclax + HMAs on the BAT arm, expecting an upper-quartile survival tail to approach 2–3 years isn't a statistical fantasy. It's exactly what modern outpatient oncology achieves, and it is precisely why the trial is hitting an event bottleneck at 78 out of 80 deaths.

The GPS arm would have some deaths clusters at the start too, the non responsive participants and ones that didn’t generate an immune response yet. If all of BAT were dead we would hit 80 from the initial non-responders.

Ven/aza could be as high as 12. but again, you could have 63 BAT deaths and still not be at 80 - BAT mOS being a few months higher is not enough to explain the delay.

yea there really is no possible way for the HR to be above .636 without an 80th event by july 2026. You'd need a crazy BAT mOS combined with something insane for the 3 year OS. Id put the chances at less than 1%, my monte carlo simulations have the probability at even less than that

Looking at this I was weighing them too heavily at the end… my estimates are wrong…yeah mOS is going to be longer, that does put it out of reach even with a strong performance in the BAT. Bullish for the Hazard ratio.

New data from ASCO just ONE MONTH AGO completely dunks on the super BAT case. 25% 3 year OS in CR1, you need a 30% 3 year OS in regal to push HR in the danger zone. 3 year OS won't be above 15% in all likelihood in REGAL BAT

but carry on with your super BAT.

pooled mOS is over 25 months, if it were 17 months we'd have seen 60 deaths in mid 2024 and 80 deaths in 2025. BAT at 12 months means the HR is below .35, need it to be above 16 months just to get HR above .5

Thank you for your detailed responses and conversations. I don't know why people are being so rude to you.
The way I see it, there are basically two reasons they could fail. One is Ven, let's [assume](https://chaotropy.substack.com/p/sellas-why-the-bear-case-might-not?utm_campaign=post-expanded-share&utm_medium=post%2Bviewer&triedRedirect=true) that won't have a material impact on the trial. The other is, as you pointed out, depends on how much the six month cutoff impacts the results.
What do you think of the argument that the most comparable group in the published research is intermediate full second remission in the 2010 Kurosawa study, or (as I understand it) the black line in Chart C in Figure 4 of the following? That would indicate a roughly 20% OS at year 3 for BAT, which would seem to tilt the odds towards GPS success if the trial continues much longer.
[Prognostic factors and outcomes of adult patients with acute myeloid leukemia after first relapse | Haematologica](https://haematologica.org/article/view/5781)

Yes for sure. BAT is suddenly vastly outperforming the historical data, because they excluded the patients that were already on the verge of dying. Which equally benefits the GPS arm btw due to higher immune response. Makes sense.

"It could come in double or more. I think we all believe that GPS is doing something, but enough to clear the Hazard Ratio?"
Yes, even if BAT doubles, GPS would still easily clear the hazard ratio target of 0.636. The math has already been done on this several times over. BAT has to go over 18, I think maybe go to even 21 before we start seeing possibilities of HR not being met.
Now is BAT CR2 pulling 18-21 months when BAT couldn't do that in CR1 (14.7 months from Vialle-M study)? Is BAT CR2 pulling numbers that require stem cell transplant in REGAL for which the patients are transplant ineligible? The answer is of course "no". And the doctors most experienced with AML, Dr. Omer Jamy and Dr. Tsirigotis, the very doctors who are involved in the REGAL study, also openly stated CR2 durability has not changed in the last 5 years.
Bears will never argue the math because the math (and biology) cannot be argued with. This is why they only ever try "what if" to cast doubt.

More like 60%.
Crux of the problem is BAT is NOT coming in under 6 mOS. It could come in double or more. I think we all believe that GPS is doing something, but enough to clear the Hazard Ratio?
If BAT was truly that low, do we have reasonable expectation that somehow GPS mOS exploded over phase 2? Probably not, but aggregate mOS could be consistent with GPS working in line with prior results, but also the BAT mOS climbing into the early teens.
Those numbers Hazard Ratio has a chance of hitting, but becomes closer to a coin flip, but this is example would also give us confirmation on the phase 2 results that GPS shows clinically meaningful response, and could have its own place in treatment going forward… it would just take more time and money to move to approval and the market.

You seem totally clueless for how a wt1 cancer immunotherapy can work and why if it succeeds it portends a paradigm shift. You seem not to grasp at all why people with unfavorable mutations that make them naturally resistant to traditional BAT aml treatment are living 2,3 times longer in 009. If you were doing my company valuation I would be toast

*Angotzi et al., (2024). "Efficacy and safety of venetoclax plus hypomethylating agents in relapsed/refractory acute myeloid leukemia: a multicenter real-life experience."* Published in *Frontiers in Oncology*
In this study there is a group of patients that is surviving longer. **"The median OS was 8.2 months, reaching 20.1 months among responding patients (23 patients including CR CRi PR and MLFS)."**
This is with current new treatment and patients in good condition, and with certain subtype of AML. so selected group. You don’t think all survivors in SLS are from the treatment arm. So the thesis patient can’t survive longer than 12 months in BAT is incorrect. Median of 20.1 means some are surviving longer than 20.1 month .

The trial passed IA so we know at that point there was some level of effect otherwise the IDMC would have halted the trial for harming patients.
I am of course open to any arguments or theories as to why the BAT arm is outperforming estimates, but none of those show a possibility that the arm is performing well enough to come even close to the numbers we are seeing in REGAL survival.
What does have some evidence from p2 trials is that GPS can increase survival more than expected.