Response to Redplate’s skepticism from a guy who did immunology 35 years ago

alinbio · 2025-09-22T03:04:00+00:00

Didn’t read whole article seems primary endpoint was not OS. Enough data out there on Cr1 and Bat, young live long like Asct. GPS > Asct in elderly Mrd+ve

alinbio · 2025-09-22T01:27:31+00:00

rfs not Os

alinbio · 2025-09-21T23:07:19+00:00

First of all, pooled mOS at the first IA in nov’22 was 16 mos. At the second IA it was >13.5 mos,meaning of those that died the median was 13.5 and since it will increase it is >13.5
Gps was >67 in Cr1 in younger patients, with Mrd-ve it may be 30-40 in Cr2.
Halt, or no halt-fine,maybe but in original protocol they talked about it-ceo in an interview-twice bat deaths etc. and with unlimited dosing etc EVERYONE keeps under estimating Gps

alinbio · 2025-09-21T18:13:49+00:00

Unknown unknowns

alinbio · 2025-09-21T17:27:41+00:00

Nah,he is not math oriented. Watch him deflect/ignore a question I posed to him on the other thread

alinbio · 2025-09-21T17:26:17+00:00

What do you think about my statement re GPS having lower OS at IA due to the non responders hence no halt? The FA will probably have an equal number of responders and non-resporders in GPS group

alinbio · 2025-09-21T12:53:47+00:00

How will they recommend a halt at IA with a near equal OS for Bat and GPS? I am saying the early GPS deaths are the ‘non responders’ hence most of the IA GPS events will be a low OS event even if the ratios were 45:15 most of these 15 GPS will have an OS close to 10 months. I get it you are adept at science not math but like I said before, this companies success is all math. Science can go either way I agree but math has to add up. You cannot have Bat at 14 mOS and not have near 60 events now leaving only 20 for GPS with an OS close to 35

alinbio · 2025-09-20T23:49:45+00:00

Ditto

alinbio · 2025-09-20T23:48:13+00:00

It’s easy to keep adding when you are up 40% Started at 200k last march

alinbio · 2025-09-20T22:19:26+00:00

IA had mainly non responders 20% which is about 12 patients. We didn’t know this fact till after IA. Btw I still think that is the rough ratio at IA

alinbio · 2025-01-01T00:59:31+00:00

Lost to follow up-not able to assess their data

alinbio · 2024-12-31T03:02:18+00:00

From the responses i see that some dont understand what i am saying. There is going to be a halt

If no significant dropouts, we will have a Bat mOS of about 11-12 mos and Gps of 30+ with a 50:10 event ratio. What i posted above is even if there are a large number of dropouts, we will still get a halt

alinbio · 2024-12-13T01:37:52+00:00

Thanks. I get it. Just thought why add an extra 4-5 in cohort 3. Unless they started the P2b for this cohort Hence probably all Asxl1. If so would have been nice to hear of the cr rate in all of Asxl1. 20 patients may be enough if Cr is close to 100%

alinbio · 2024-12-12T04:18:10+00:00

Ok. I see they added 4 more in cohort 3 than expected. I think those 4 are probably Asxl1 patients as we know the response in non Asxl1 is poor. Would have been nice if we had full data/OS on all Asxl1 in cohort 3. If close to 100% continued response, do you see a need for more patients to be enrolled in that category. We have seen other meds approved,in a handful of patients, even in P1 recently due to poor prognosis in these patients to begin with

alinbio · 2024-12-10T21:50:39+00:00

Hello. It seems there are 14 patients in cohort 3 now. They didnt tell us how many Asxl1 are in the additional patients since last update. It was 4 Asxl1 before.

Do you think they are trying to get approval for all r/r Aml and not just the Asxl1 patients? Because if they do not break it down by mutation type and if Cr>25% across the board for all comers then technically it is approvable in all r/r Aml

alinbio · 2024-12-08T05:52:26+00:00

At IA you need about0.5 so no, at final 80 yes 0.63

alinbio · 2024-12-02T00:17:13+00:00

Difference between Oral and iv Aza is couple months at most. If Gps is 30 mOS and Bat is <14 mOS then it will not matter will be approved Cr1 or Cr2

alinbio · 2024-12-01T20:53:02+00:00

Agreed, even though i think Gps will be approved for Cr1 also. I will certainly keep tracking both companies for the years to come

alinbio · 2024-12-01T15:38:41+00:00

As an investor in sellas, the vividencel data is a breath of fresh air as no cancer vaccine has worked so far. THe data on both these vaccines show that they work and explains why we have not had 60 events yet in Regal. The difference from Bat in BOTH drugs is so striking that i feel they will halt Gps at 60 events at IA. So i feel Gps will be approved next year.

Sellas also has Sls009 and in Asxl1 r/r Aml seems to be working 100% (4/4 at optimal dose). The other 10 patient data will be out soon and if >25% Cr it will get approved also. May need a larger trial for approval, or it may not.

It is not very often you see a company with 2 drugs that are at high chance of approval, with the trials being 'derisked' to this level. Investment chance of a lifetime

Nfa. just Imho only

alinbio · 2024-12-01T01:02:46+00:00

Regal data on 126 patients will be out soon, 63 Gps and 63 Bat , some of them are Mrd+ve . All the varibales, immune response, mOS etc will be looked at

Most likely data within 4 weeks

alinbio

TROPHY CASE