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$SLS Let&#39;s take a deep dive looking at the long BAT tail risk for REGAL. The bear thesis is a specific mechanism: patients randomized to BAT can leave the maintenance/observation world and bridge to allogeneic transplant (allo-HCT) while in CR2, either because a donor is finally identified, or because they relapse and are salvaged back into a transplantable state. Transplant is potentially curative, so if enough BAT patients get transplanted, the control arm grows a long survival tail that could erase the GPS advantage. 
 
Based on @yG19s excellent work, the study at risk if (among other unlikely variables)  &gt; 45% of the BAT arm transplants. Here&#39;s where the published evidence lands (love open evidence). 
 
The single most important concept is that being in CR2 is the end of a long attrition funnel, not the start of one. A patient must survive relapse, be fit enough for re-induction, actually achieve CR2, have (or find) a donor, and stay in remission long enough to reach the transplant date. Every step sheds patients. 
 
Kurosawa et al. (Haematologica 2010, n=1,015 relapsed AML): the cleanest dataset, because it starts counting at relapse . Of 931 relapsed patients with full follow-up, 50% achieved CR2, and only ~26% were transplanted while still in CR2. Their words: &quot;of all patients who relapsed without a transplant in CR1, only one-third went on to receive a transplant in CR2.&quot; 
 
MRC AML10/12/15 (UK; Burnett/Wheatley data): Of ~2,029 intermediate-risk patients entering CR1, one-third were transplanted in CR1. Of the 1,271 (60%) not transplanted in CR1 who then relapsed, only ~half (642) achieved CR2, and only one-third of those who relapsed ultimately received a transplant in CR2. Same funnel, same terminal fraction. 
 
Across UK, Japanese, and US cohorts spanning thousands of patients, the CR2-transplant rate clusters at roughly 25–35% of patients, and that&#39;s measured in populations WITHOUT the extra frictions REGAL imposes.  
 
Two REGAL-specific factors push it lower still: 
 
These are patients already in CR2 at enrollment who did not have a transplant lined up. The &quot;easy&quot; candidates, those with a ready sibling donor for example, get transplanted before they&#39;d ever be randomized into REGAL. The trial population is enriched for patients not on an immediate transplant path. The bridge has to happen inside the trial&#39;s follow-up window, in remission. The gap between &quot;achieved CR2&quot; and &quot;transplanted in CR2&quot; is exactly where most candidates are lost, from relapse, comorbidity, donor delay, or patient choice. 
 
Getting from a real-world ceiling of ~35% to the &gt;45% the bear case requires, in a population selected against immediate transplant, is a steep climb. 
 
Even the ones who bridge don&#39;t get a permanent tail. 
 
The bear thesis implicitly treats a BAT-arm transplant as a permanent escape to the survival plateau. But allo-HCT in AML relapses often, and early, which caps the length of any tail bridged patients can produce inside the observation window. 
 
Yanada et al. (Bone Marrow Transplantation / Nature, 2021) — the largest dedicated study of relapse kinetics after allo-HCT for AML. In 1,265 patients who relapsed after allo-HCT performed in CR (CR1 and CR2 combined however), the median time to relapse was 6.1 months. A BAT patient who bridges late in the trial and then relapses at a 6-month median doesn&#39;t generate an indefinite survival tail, they re-enter the high-mortality relapsed/refractory state measured in months. 
 
And on top of that. Some attached clips from the NMDP national survey of US Hem/Onc physicians shows the main cited reasons why a randomized BAT patient may never bridge: comorbidities (still the top barrier at 65%), older age (63%; the average maximum referral age in 2024 was 73.5 years), non-transplant options available, and logistics like distance, insurance, and donor availability. And as we&#39;ve discussed before, going through transplant is a GRIND (GvHD, prolonged hospitalization, etc) and patients seems to be seeking this out even less &quot;patient declined referral&quot; rose (42% -&gt; 52%).  
 
Bottom line 
 
The &quot;long BAT tail from CR2 bridging&quot; is a real mechanism, but every large real-world AML CR2 cohort bounds it hard. The rate required to flip REGAL sits outside the range ever observed: referral leaks, the CR2 funnel caps the middle at 25–35%, trial selection depletes the easy candidates, and a ~6-month median relapse decays the tail downstream.

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$SLS @LeftyMD this was a fun college brainstorm &quot;puke on paper&quot; and not a well thought out post.  Probably good enough for the Rope Hat audience, but not for the rest of us.  
 
While I appreciate the acknowledging the role in Stem Cell Transplant in REGAL P3, I think some of your conclusions (Or &quot;hope pumps&quot;) miss the target.  Throwing a bunch of previous studies that don&#39;t directly relate to REGAL is weak, and confusing to the audience.   
 
You&#39;re basically acting like a Car Salesman telling us every amenity on a new car, but still won&#39;t answer our only question of whether there were heated seats or not.  Fluff the RHs, but you would have gotten a lot more traction simply acknowledging the possibilities.   
 
Maybe a better showing next time, but you fumbled this one.  
 
Cheers!

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$SLS @LeftyMD @yG19s this is excellent as always.

Let me distill this down in layman’s terms.

The barriers to a patient actually going into Regal in CR2 status ineligible or unwilling to transplant, and then converting to a stem cell transplant are incredibly high.

The reality is the amount of Regal patients who ever did this is no more than a handful maybe 3-5 -  that’s it. 

There are simply not going to be dozens of patients in Regal who did this.

And even if tonthe extent there are are a handful of stem cell transplant in Regal, such a transplant at CR2 status is not as potentially curative at this  more serious, advanced and aggressive stage of the disease.  The odds and speed of a relapse are higher for a post transplant CR2 patient than at earlier stages of AML.

@LeftyMD if I have misstated the facts, please do correct me.

$SLS now that’s how you DD. Great post. #40billy #godzilla

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$SLS honestly its hard for me to understand the depth of this post as im sure it is for most of our longs. However I understand very clearly the 7 green letters &quot;BULLISH&quot;  under your post.

John Pace

SELLAS Life Sciences Group Inc

 Let's take a deep dive looking at the long BAT tail risk for REGAL. The bear thesis is a specific mechanism: patients randomized to BAT can leave the maintenance/observation world and bridge to allogeneic transplant (allo-HCT) while in CR2, either because a donor is finally identified, or because they relapse and are salvaged back into a transplantable state. Transplant is potentially curative, so if enough BAT patients get transplanted, the control arm grows a long survival tail that could erase the GPS advantage. 
 
Based on 

 excellent work, the study at risk if (among other unlikely variables)  > 45% of the BAT arm transplants. Here's where the published evidence lands (love open evidence). 
 
The single most important concept is that being in CR2 is the end of a long attrition funnel, not the start of one. A patient must survive relapse, be fit enough for re-induction, actually achieve CR2, have (or find) a donor, and stay in remission long enough to reach the transplant date. Every step sheds patients. 
 
Kurosawa et al. (Haematologica 2010, n=1,015 relapsed AML): the cleanest dataset, because it starts counting at relapse . Of 931 relapsed patients with full follow-up, 50% achieved CR2, and only ~26% were transplanted while still in CR2. Their words: "of all patients who relapsed without a transplant in CR1, only one-third went on to receive a transplant in CR2." 
 
MRC AML10/12/15 (UK; Burnett/Wheatley data): Of ~2,029 intermediate-risk patients entering CR1, one-third were transplanted in CR1. Of the 1,271 (60%) not transplanted in CR1 who then relapsed, only ~half (642) achieved CR2, and only one-third of those who relapsed ultimately received a transplant in CR2. Same funnel, same terminal fraction. 
 
Across UK, Japanese, and US cohorts spanning thousands of patients, the CR2-transplant rate clusters at roughly 25–35% of patients, and that's measured in populations WITHOUT the extra frictions REGAL imposes.  
 
Two REGAL-specific factors push it lower still: 
 
These are patients already in CR2 at enrollment who did not have a transplant lined up. The "easy" candidates, those with a ready sibling donor for example, get transplanted before they'd ever be randomized into REGAL. The trial population is enriched for patients not on an immediate transplant path. The bridge has to happen inside the trial's follow-up window, in remission. The gap between "achieved CR2" and "transplanted in CR2" is exactly where most candidates are lost, from relapse, comorbidity, donor delay, or patient choice. 
 
Getting from a real-world ceiling of ~35% to the >45% the bear case requires, in a population selected against immediate transplant, is a steep climb. 
 
Even the ones who bridge don't get a permanent tail. 
 
The bear thesis implicitly treats a BAT-arm transplant as a permanent escape to the survival plateau. But allo-HCT in AML relapses often, and early, which caps the length of any tail bridged patients can produce inside the observation window. 
 
Yanada et al. (Bone Marrow Transplantation / Nature, 2021) — the largest dedicated study of relapse kinetics after allo-HCT for AML. In 1,265 patients who relapsed after allo-HCT performed in CR (CR1 and CR2 combined however), the median time to relapse was 6.1 months. A BAT patient who bridges late in the trial and then relapses at a 6-month median doesn't generate an indefinite survival tail, they re-enter the high-mortality relapsed/refractory state measured in months. 
 
And on top of that. Some attached clips from the NMDP national survey of US Hem/Onc physicians shows the main cited reasons why a randomized BAT patient may never bridge: comorbidities (still the top barrier at 65%), older age (63%; the average maximum referral age in 2024 was 73.5 years), non-transplant options available, and logistics like distance, insurance, and donor availability. And as we've discussed before, going through transplant is a GRIND (GvHD, prolonged hospitalization, etc) and patients seems to be seeking this out even less "patient declined referral" rose (42% -> 52%).  
 
Bottom line 
 
The "long BAT tail from CR2 bridging" is a real mechanism, but every large real-world AML CR2 cohort bounds it hard. The rate required to flip REGAL sits outside the range ever observed: referral leaks, the CR2 funnel caps the middle at 25–35%, trial selection depletes the easy candidates, and a ~6-month median relapse decays the tail downstream.

LeftyMD

@LeftyMD @yG19s this is excellent as always.

Let me distill this down in layman’s terms.

The barriers to a patient actually going into Regal in CR2 status ineligible or unwilling to transplant, and then converting to a stem cell transplant are incredibly high.

The reality is the amount of Regal patients who ever did this is no more than a handful maybe 3-5 -  that’s it. 

There are simply not going to be dozens of patients in Regal who did this.

And even if tonthe extent there are are a handful of stem cell transplant in Regal, such a transplant at CR2 status is not as potentially curative at this  more serious, advanced and aggressive stage of the disease.  The odds and speed of a relapse are higher for a post transplant CR2 patient than at earlier stages of AML.

@LeftyMD if I have misstated the facts, please do correct me.

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 this is excellent as always.

Let me distill this down in layman’s terms.

The barriers to a patient actually going into Regal in CR2 status ineligible or unwilling to transplant, and then converting to a stem cell transplant are incredibly high.

The reality is the amount of Regal patients who ever did this is no more than a handful maybe 3-5 -  that’s it. 

There are simply not going to be dozens of patients in Regal who did this.

And even if tonthe extent there are are a handful of stem cell transplant in Regal, such a transplant at CR2 status is not as potentially curative at this  more serious, advanced and aggressive stage of the disease.  The odds and speed of a relapse are higher for a post transplant CR2 patient than at earlier stages of AML.



 if I have misstated the facts, please do correct me.

@LeftyMD @yG19s  
Not to mention that transplant is a potential for both arms, correct?

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Not to mention that transplant is a potential for both arms, correct?

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@Parsnipchewter @yG19s Correct. GPS-arm transplants can only ever lift the GPS curve. For transplant to flip the study toward BAT, you don&#39;t just need transplants to happen, you need BAT to transplant at a materially higher rate than GPS.

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 Correct. GPS-arm transplants can only ever lift the GPS curve. For transplant to flip the study toward BAT, you don't just need transplants to happen, you need BAT to transplant at a materially higher rate than GPS.

@LeftyMD @yG19s 

Great observations Lefty. Trial design does matter. I think in this case it’s pretty tight. I think the change in protocol to allow unlimited dosing until relapse will be the nail in the coffin of shorts. That plus the robust epitope spreading MEASURED IN THE CLINICAL TRIAL .. will prove to be the factor pushing over the finish line

Ulaughing

 

Great observations Lefty. Trial design does matter. I think in this case it’s pretty tight. I think the change in protocol to allow unlimited dosing until relapse will be the nail in the coffin of shorts. That plus the robust epitope spreading MEASURED IN THE CLINICAL TRIAL .. will prove to be the factor pushing over the finish line

Tully

@LeftyMD also I&#39;m pretty sure that Sellas as a company(since they are sponsors of the Regal trial)  are notified whenever a patient on either arm decides to get a Cell Transplant since that is technically not approved for patients in the study. Below is the publicly available Regal SAP where I&#39;ve outlined the sections that indicate they get notified of Cell Transplants. This would explain why the CEO is so bullish since he knows the exact count of SCT and that it&#39;s a non issue.

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 also I'm pretty sure that Sellas as a company(since they are sponsors of the Regal trial)  are notified whenever a patient on either arm decides to get a Cell Transplant since that is technically not approved for patients in the study. Below is the publicly available Regal SAP where I've outlined the sections that indicate they get notified of Cell Transplants. This would explain why the CEO is so bullish since he knows the exact count of SCT and that it's a non issue.

Mark15763

@LeftyMD @yG19s  thank you Lefty!  From what I could deduce, in this population, the likelihood of referrals being anywhere higher than 5% in this population is non-existent.  And, IMO, the inclusion/exclusion criteria being so specific would seem to ensure that ceiling is not tested.  As you wrote, the easy referrals were already weeded out.

  thank you Lefty!  From what I could deduce, in this population, the likelihood of referrals being anywhere higher than 5% in this population is non-existent.  And, IMO, the inclusion/exclusion criteria being so specific would seem to ensure that ceiling is not tested.  As you wrote, the easy referrals were already weeded out.

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@LeftyMD @yG19s wow. get fucking owned bears. this is devastating to your thesis. get buttfucked.

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 wow. get fucking owned bears. this is devastating to your thesis. get buttfucked.

@Mark15763 Thanks for this Mark. They would be blinded so not likely to know which arm the transplants occured in but may the total number. I wonder if under an NDA a potential acquirer would be allowed access to this, would be very interesting.

 Thanks for this Mark. They would be blinded so not likely to know which arm the transplants occured in but may the total number. I wonder if under an NDA a potential acquirer would be allowed access to this, would be very interesting.

@LeftyMD so I would agree the &quot;Sponsor&quot; Sellas is blinded to trial results and outcomes but if you look at the wording it says &quot;notification of early discontinuation will be made to the sponsor&quot; which makes it seem they will be updated as the trial progresses not at the end otherwise what would the be &quot;notifying&quot;

Willy

 so I would agree the "Sponsor" Sellas is blinded to trial results and outcomes but if you look at the wording it says "notification of early discontinuation will be made to the sponsor" which makes it seem they will be updated as the trial progresses not at the end otherwise what would the be "notifying"

@LeftyMD @yG19 Hi, i was reading BAT 25% are observation and 25% are LDAC. 0% from those go to transplant as neither can bridge.  
 
1. The VIALE-A Landmark Data (DiNardo et al., NEJM) 
In the definitive Phase 3 trial establishing Azacitidine + Venetoclax for older or unfit patients with newly diagnosed AML, the baseline population was strictly restricted to those ineligible for intensive induction or stem cell transplant. Despite the high complete response rates, only ~5.5% of the patients randomized to the active combination arm ultimately crossed over to receive an allogeneic stem cell transplant on-study. 
 
31.5*0.05 = 1.575 get to transplant from Ven / HMA combo

 Hi, i was reading BAT 25% are observation and 25% are LDAC. 0% from those go to transplant as neither can bridge.  
 
1. The VIALE-A Landmark Data (DiNardo et al., NEJM) 
In the definitive Phase 3 trial establishing Azacitidine + Venetoclax for older or unfit patients with newly diagnosed AML, the baseline population was strictly restricted to those ineligible for intensive induction or stem cell transplant. Despite the high complete response rates, only ~5.5% of the patients randomized to the active combination arm ultimately crossed over to receive an allogeneic stem cell transplant on-study. 
 
31.5*0.05 = 1.575 get to transplant from Ven / HMA combo

@LeftyMD @yG19s excellent post as always. I also found a very recent June 22, 2026 publication by Nguyen and Kantarjian at MD Anderson in the journal Clinical Cancer Research where they looked at 657 R/R AML patients undergoing second treatment salvage therapy (akin to AML CR2 patients relapsing and then getting salvage treatment). They found that only 10% of these patients bridged to allogeneic stem cell transplant. Given that this was at one of the very best cancer hospitals in the world, I would expect the rate to be even lower at most other places. (Clin Cancer Res. 2026 Jun 22. doi: 10.1158/1078-0432.CCR-26-0951. Online ahead of print)

Tony M

TTP222

 excellent post as always. I also found a very recent June 22, 2026 publication by Nguyen and Kantarjian at MD Anderson in the journal Clinical Cancer Research where they looked at 657 R/R AML patients undergoing second treatment salvage therapy (akin to AML CR2 patients relapsing and then getting salvage treatment). They found that only 10% of these patients bridged to allogeneic stem cell transplant. Given that this was at one of the very best cancer hospitals in the world, I would expect the rate to be even lower at most other places. (Clin Cancer Res. 2026 Jun 22. doi: 10.1158/1078-0432.CCR-26-0951. Online ahead of print)

Huong Wei Lo

@kpopinvestor @yG19 Those % were design intent but not hard numbers and I wouldn&#39;t assume 25% were on observation only. Regarding VIALE-A. VIALE-A skews old (median 76), but the bigger reason the crossover is so low is that the trial enrolled only transplant-ineligible patients by design, so ~5.5% is really a floor for an untransplantable population. But it shows how real-world bridge rates collapse once fitness is accounted for. I am sure REGAL will be higher than this.

 Those % were design intent but not hard numbers and I wouldn't assume 25% were on observation only. Regarding VIALE-A. VIALE-A skews old (median 76), but the bigger reason the crossover is so low is that the trial enrolled only transplant-ineligible patients by design, so ~5.5% is really a floor for an untransplantable population. But it shows how real-world bridge rates collapse once fitness is accounted for. I am sure REGAL will be higher than this.

@LeftyMD @yG19s ok but both arms are eligible and most of the patients were not eligible for bmt. The whole point is to find as many no eligible patients to test a theory. No more than 5% percent of all patients likely 2 and no more than five underwent bmt and the numbers must be adjusted for that change. Great post but it&#39;s a dumb theory as we are testing the efficacy of gps not bmt.

 ok but both arms are eligible and most of the patients were not eligible for bmt. The whole point is to find as many no eligible patients to test a theory. No more than 5% percent of all patients likely 2 and no more than five underwent bmt and the numbers must be adjusted for that change. Great post but it's a dumb theory as we are testing the efficacy of gps not bmt.

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@LeftyMD @yG19s wouldn’t the REGAL SCT exclusion criteria cause those patients who became eligible for transplant to be censored and therefore considered to be similar to the other patients in the same arm of the study?

 wouldn’t the REGAL SCT exclusion criteria cause those patients who became eligible for transplant to be censored and therefore considered to be similar to the other patients in the same arm of the study?

@Thestokinator @yG19s Agree transplant isn’t likely a threat here, but not because it’s a “dumb theory”. Two things contain it. 1) it’s intention-to-treat, so any transplant survival counts for the arm the patient was randomized to; GPS transplants can’t leak onto BAT. (2) Even where BAT patients relapse and get salvaged toward transplant, only ~25–35% of relapsers actually reach a CR2 graft, and those relapse at a ~6-month median. 

REGAL bridged transplants will be around 10 in my opinion.

Paul Nipkow

 Agree transplant isn’t likely a threat here, but not because it’s a “dumb theory”. Two things contain it. 1) it’s intention-to-treat, so any transplant survival counts for the arm the patient was randomized to; GPS transplants can’t leak onto BAT. (2) Even where BAT patients relapse and get salvaged toward transplant, only ~25–35% of relapsers actually reach a CR2 graft, and those relapse at a ~6-month median. 

REGAL bridged transplants will be around 10 in my opinion.

@LeftyMD @Thestokinator @yG19s 10 transplant just in BAT? Am I get it right?

 10 transplant just in BAT? Am I get it right?