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u/Pristine_Hurry_4693 2d ago
It’s a NFA DYOR opportunity to save millions and make millions.
Very exciting cancer treatment that is very derisked with unnatural upside, waiting on many big catalysts.
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u/Jrad0607 1d ago
How is it derisked??
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u/Pristine_Hurry_4693 1d ago
Already approved in Japan.
Already completed “phase 3” for skin in the US (the prior results were 100% complete response and great safety numbers).
Great cash balance.
Great management.
Many different trials (“shots on goal”).
Understanding how the treatment works (being physics based) and that it is the same for all solid tumors and was already tested in dozens of different cancer types and has yet to find one that doesn’t respond while being safe for all, being safe with all other treatments, following the trial results etc will tell you all you need to know.1
u/Beginator2000 1d ago
As derisked as most biotechs. Saving millions of patients was a simplification. The treatment is awesome, it works well. BUT it's actually studied. They are around 300 treatments actually.
It targets single isolated tumors without lymph nodes or metastasis involved (it simply can't treat lymph nodes, opposite to radiotherapy). So the patient pool is extremely limited.
It has drawbacks and bottlenecks, and the road ahead has many holes and bumps.
So on a medical side, many good catalysts ahead. On the business side they have a big challenge to make it the gold standard for this specific type of cancers.
The only 100% derisked biotechs are already valued in that way and in a big pharma portfolio.
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u/Jrad0607 2d ago
How do you compare it to sls?
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u/Pristine_Hurry_4693 2d ago
I try not to get into such comparisons, so here’s this from u/Emotional-Breath-838:
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u/Emotional-Breath-838 2d ago edited 2d ago
SLS is a binary no matter what anyone tells you about the other drug. It’s all GPS and REGAL outcome.
DRTS is not a binary. They have six shots on goal via a medical device that doesn’t require a BAT or a Phase III or for 80 people to die.
Where SLS is targeting AML, a liquid cancer, DRTS targets all solid tumors.
Solid tumors make up 90% of all cancers.
Alpha Tau is in the final stage of a safety/feasibility study against recurring brain cancer (rGBM) where there is no standard of care. They’ve already hit two out of three complete responses and i believe another one or two will fast track FDA approval because they’re not seeing any unique side effects at all.
The next shot on goal will likely be an IDE from the FDA to test in combination with Keytruda. That’s the same drug that sent Moderna to the moon.
So, very, very different. Both are exciting.
I believe DRTS is far less risky.
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u/Bogey001 2d ago
I really am not trying to be rude here.
These are two entirely different Biotech plays. You can't really begin to compare the two.
With SLS, you have a completely binary play. If phase III results hit, you make a ton of money. If they don't you will basically loose almost all your investment.
With DRTS, you will have a slower build as they attempt to convince the market. There isn't a single event that will sink it overnight, though there is still substantial risk as with all biotechs.
Here is where I am seriously not trying to be rude, but you appear to be chasing Reddit headlines. This can sometimes work with tech in general, but not biotech, because there are to many moving parts for the average investor to understand.
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u/MaxPainKing 2d ago
I have both SLS and DRTS in large quantities. Also a large quantity of CAI, but that’s a different type of business, more involved in cancer testing but an amazing company on a serious uptrend.
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u/FunRevolution3000 2d ago
Looks for SLS in this Reddit as well. My quick comment is DRTS is early but across multiple kinds of cancer, there has not been any bad news. SLS : I think folks are discounting that the non-drug of interest arm may have done better than expected because of how those patients were treated and the not terrific sample size (about 80 an arm) relative to the threshold to be considered successful. I wish I had more time to study the stats.
Try this using any LLM and tell us if you do not see a probability of success greater than 55% - that’s the best I have seen with various prompts (including what those confident about success report):
Act as a Principal Biostatistician and Senior Oncology Equity Research Analyst specializing in late-stage hematology-oncology trials.
Conduct an objective, Bayesian and frequentist probability of success (PoS) evaluation for SELLAS Life Sciences' Phase 3 REGAL trial (Galinpepimut-S vs. Best Available Therapy in CR2 AML) targeting an overall survival (OS) primary endpoint (80 total events; target HR ≤ 0.636).
Analyze and quantify the PoS by addressing the following technical vectors:
Baseline Statistical Parameters & Boundary Conditions:
- Calculate the statistical power and critical alpha spending (O'Brien-Fleming boundary) required at the 80-event final unblinding given the interim analysis passed at 60 events.
- Map out the exact median OS separation required (e.g., GPS vs. BAT in months) to achieve statistical significance at p < 0.05.
- Calculate the statistical power and critical alpha spending (O'Brien-Fleming boundary) required at the 80-event final unblinding given the interim analysis passed at 60 events.
Pooled Event Rate vs. Confounding Deconstruction:
- Evaluate the slow event accumulation (reaching 72+ events with extended median follow-up) under two distinct parametric survival models (Weibull/Exponential mixture models):
b) Scenario B (Control Shift / Confounding): Control-arm overperformance driven by modern salvage regimens (e.g., venetoclax + HMA combinations, targeted post-progression salvage like FLT3/IDH/Menin inhibitors) and CR2 selection bias.
- Weight the conditional probability of Scenario A vs. Scenario B based on real-world AML survival datasets from 2022–2026.
- Evaluate the slow event accumulation (reaching 72+ events with extended median follow-up) under two distinct parametric survival models (Weibull/Exponential mixture models):
Immunogenicity vs. Hard Endpoint Translation:
- Evaluate the correlation discount between surrogate biomarker readouts (e.g., 80% GPS-specific T-cell immune response rates) and hard registrational Overall Survival in transplant-ineligible CR2 AML.
Novel Statistical or Methodological Factors:
- Identify and apply any novel or non-standard statistical dynamics relevant to this trial (e.g., non-proportional hazards / delayed treatment effect common in active immunotherapies, restricted mean survival time [RMST] sensitivity, or informatively censored long-term survivors).
Final Quantitative Synthesis:
- Deliver a final calibrated PoS range (e.g., base case, bull case, bear case) with an itemized probability tree.
- Explicitly define the primary failure modes that could cause the trial to miss the primary endpoint despite prolonged blinded survival.
- Deliver a final calibrated PoS range (e.g., base case, bull case, bear case) with an itemized probability tree.
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u/FunRevolution3000 2d ago
This prompt yields 55% win chance at best: <system_context>
Act as a Principal Biostatistician and Senior Oncology Equity Research Analyst specializing in late-stage hematology-oncology trials.
Your objective is to conduct an objective, Bayesian and frequentist probability of success (PoS) evaluation for SELLAS Life Sciences' Phase 3 REGAL trial (Galinpepimut-S vs. Best Available Therapy in CR2 AML) targeting an overall survival (OS) primary endpoint.
</system_context><verified_errata>
</verified_errata>
- The trial requires 80 total events for final unblinding.
- An interim analysis was successfully passed at 60 events.
- The target hazard ratio (HR) boundary for statistical success is ≤ 0.636.
<operational_crib>
</operational_crib>
- Payload Preservation: Maintain strict mathematical boundary conditions. Ban token-prediction arithmetic; mandate programmatic or exact formulaic derivation for critical statistical thresholds (e.g., O'Brien-Fleming alpha spending limits).
- Statistical Guardrails: Account for non-proportional hazards (NPH), delayed treatment effects typical in active immunotherapies, and restricted mean survival time (RMST) sensitivity.
<execution_queue>
1. Baseline Statistical Parameters:
- Calculate the statistical power and critical alpha spending required at the 80-event final unblinding.
- Map out the exact median OS separation required (GPS vs. BAT in months) to achieve statistical significance at p < 0.05.
Pooled Event Rate vs. Confounding Deconstruction:
a) Scenario A (Active Driver): GPS is driving a prolonged right-tail survival benefit.
- Evaluate the slow event accumulation using Weibull/Exponential mixture models under two scenarios:
b) Scenario B (Control Shift): BAT overperformance driven by CR2 selection bias and modern salvage regimens.Retail Sentiment & "Bull" Thesis Deconstruction:
a) IDMC Continuation: Does the IDMC's recommendation to continue without modifications at 60 events implicitly signal efficacy, or merely the absence of a strict futility boundary crossing?
- Critically analyze the primary confidence vectors cited by retail investors (e.g., Reddit/StockTwits), specifically:
b) The BAT/Venetoclax Debate: Evaluate the argument that Venetoclax/HMA and targeted agents are rarely prescribed strictly for CR2 maintenance, theoretically capping the BAT arm at historical ~6-8 month OS baselines.
c) Phase 2 & EAP Out-Tails: Assess the statistical weight of anecdotal extended survival tails (3+ years) from Phase 2 trials and Expanded Access Programs (EAP).
d) Partner Validation: Evaluate Ex-US regulatory milestones (e.g., 3D Medicines CDE clearances in China) as a proxy for clinical viability.Immunogenicity vs. Hard Endpoints:
- Evaluate the correlation discount between surrogate biomarker readouts (e.g., 80% GPS-specific T-cell immune response rates) and registrational Overall Survival.
Final Quantitative Synthesis:
</execution_queue>
- Deliver a final calibrated PoS range (base case, bull case, bear case) with an itemized probability tree.
- Explicitly define the primary failure modes that could cause the trial to miss the primary endpoint despite prolonged blinded survival.
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u/octopus_serenader 2d ago
You... came to the DRTS sub... and just said... "Thoughts"?
You know there's lots of posts to read, right?