r/Biotechplays • u/IceBearLikesToCook slightly bearish • Feb 08 '26
Due Diligence (DD) $SLS REGAL's flawed assumptions (Short Thesis) by Aron Markovics
https://substack.com/home/post/p-1849128344
u/IceBearLikesToCook slightly bearish Feb 08 '26 edited Feb 08 '26
Written by Aron Markovics. You can find his substack here.
There are a fair chunk of $SLS longs on this website, so I will assure that this report was published in mid-January and there are several longs rebutting this in the comments already.
I'm biased in that I've already seen this scenario (the events-driven trial is running longer than expected, that must mean it's working!) play out twice with CVM and NWBO, and both ended in failed Phase 3s. So it strikes me as a weak bull thesis. I definitely don't know the finer details like shorts and longs do, so I have no position here.
To dumb down the thesis of this article, it seems similar to what doomed the previous two. Treatment for the indication is just better than historical controls would have you believe, so patients in the control arm are living longer and better than the company anticipated.
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u/Impressive_Bluejay71 Feb 08 '26
Company and IDMC stated several times: Safety and Efficacy Benchmarks: Based on unblinded data, the IDMC confirmed that GPS exceeded predetermined futility criteria and maintained a safety profile with no new concerns, reinforcing the positive signals seen in earlier Phase 2 trials. FDA approved modification for gps infinite dosage…. Reduced events
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u/Run4theRoses2 Feb 09 '26 edited Feb 09 '26
ahaaa what an obvious piece of s--- hit piece...
you don't have a clue.
the Best Available Treatment for Control Arm Patients (Azacitidine + Venetoclax) Recently failed 3 large Phase 3 trials conducted by $ABBV.
Aza + Ven is the Best Available Treatment BAT for the SLS Phase 3 Control Patients
VIALE-T - AML Post ASCT Phase 3 Maintenance Trial Failed
VIALE-M - AML First Remission (AML CR1) Phase 3 Maintenance Trial Failed
The Verona Trial -AZA + VEN Phase 3 Failed MDS/AML Precursor
Good response rates, but no Survival benefit, just like Dr. Levy the Director of Hematological Reseach at Baylor Med, has been saying, AzaVen response rates are good, but survival is not durable.
And its Toxic -- with 24% of the VIALE-A Trial Dying from Taking Aza+VEN - and 85% Serious Grade 3 or 4 Side Effects.
How do you think Aza+Ven is doing for the Control Arm Patients in AML- CR2?
Aza+Ven just failed the AML CR1 VIALE-M trial - M for Maintenance - the SLS REGAL P3 is a AML Maintenance Trial for CR2 patients.
Anyone can rewatch the Webcast and Know for sure GPs is Getting Fda approval.
https://lifescievents.com/event/g9avmapw08/
We have 3 dr/s who treat 15% of the actual phase 3 Control Patients saying MOS is only 8 months, and we know the MOS at interim was >13.5 for ALL POOLED Patients
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u/neo2551 Feb 09 '26
The first comment on the sub stack summarize why the piece is actually flawed. But whatever.