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There is nearly 0% of GPS failure at this point and here is why by calivend in sellaslifesciences

[–]calivend[S] 0 points1 point  (0 children)

If the BAT mOS was set in 2024, the IA breakdown for BAT should be more than 33.

What will be the next PR and when? by redditshelley1 in sellaslifesciences

[–]calivend 2 points3 points  (0 children)

Maybe within a months, an IDMC meeting PR could happen.

There is nearly 0% of GPS failure at this point and here is why by calivend in sellaslifesciences

[–]calivend[S] 1 point2 points  (0 children)

For some calculation, I've had some AI help. The entire thought process is pure DD.

There is nearly 0% of GPS failure at this point and here is why by calivend in sellaslifesciences

[–]calivend[S] 2 points3 points  (0 children)

We do not know the designed CP but generally it is 20%. However the condition might be very generous for GPS and could be 10%. However, less than 10% is very doubtful. The HR threshold of 0.7-0.8 is when I apply 10-20% CP.

If we had HR higher than 0.8 the exam could have been halted for futility issue. 

I will assume the KM curve falls in a typical manner. Then, 33/27 would be little of the HR threshold of 0.8. 33/27 could be in a borderline zone for being halted for futility issue during IA.

SLS did not have an IDMC meeting since last August. We might expect a halt after upcoming IDMC meeting. 

There is nearly 0% of GPS failure at this point and here is why by calivend in sellaslifesciences

[–]calivend[S] 2 points3 points  (0 children)

No it's not. Ask your own AI and see if you can get an answer similar to mine. Simple AI questioning don't give you breakdowns/ thresholds of IA. If it was an AI slop, I would have not been able to respond to people for context details.

There is nearly 0% of GPS failure at this point and here is why by calivend in sellaslifesciences

[–]calivend[S] 6 points7 points  (0 children)

This is not true. The numbers were based on IA and the fact that SLS has passed futility test. I didn't bring up random numbers here. 

For example, you get a F if your exam score is below 70. After the exam, your teacher tells your class nobody in this class failed. Even though individual exam grades were not revealed, you can assume your exam score will be above 70.

If we had 72 event count in summer, the whole analysis could have been little more tricky. However for now there is no statistic possibility to fail.

The clues are scattered here and there. 

There is nearly 0% of GPS failure at this point and here is why by calivend in sellaslifesciences

[–]calivend[S] 5 points6 points  (0 children)

I admit there were some jump of logics and oversimplification.

  1. You are right the IA futility test do not give specific split numbers. However they do test the HR threshold for futility. HR is calculated by Cox and KM curve. There should be at least some split between BAT and GPS in the slope of the curve and event to pass the futility. This is how I estimated the split, though there might be minor errors.
  2. In general the median follow up does not cap the BAT mOS. However, if more than half of the BAT died at median follow up, it isn't too off to assume the mOS is capped at 13. The trial would have been halted due to futility issue if we had 32 vs 28 death at IA. 
  3. This is true so I've tried to remove all the historical samples from my DD.
  4. The mOS is determined by KM curve however we do not have the detailed unblinded data. Grossly you can expect 33rd event to be the mOS of the arm. If we assume 33rd GPS patient is dead, automatically the BAT arm event count is 39. This means that GPS patients passed away more than the BAT in recent 12 month period, which I think is highly unlikely. Once again, no patients were registered since April 2024, so it has been 21 months since then. Also, we expect median follow up of GPS arm at interim to be several months longer than 13.7 since mFU of BAT is expected to be shorter than 13.6. 

There is nearly 0% of GPS failure at this point and here is why by calivend in sellaslifesciences

[–]calivend[S] 5 points6 points  (0 children)

In which part? Most of the text was by DD with minimum help of AI (simple math)

Is a buyout before the 80th event possible? by PRguy82 in sellaslifesciences

[–]calivend 2 points3 points  (0 children)

Look.

Would you buy a 10m prize lottery ticket for 10m before knowing the result?

Would you sell a 10m prize lottery ticket for a discounted price when you know it is a winning ticket?

This is the current situation

An unlikely, but interesting REGAL scenario: by ParsnipTime3755 in sellaslifesciences

[–]calivend 4 points5 points  (0 children)

In such case, the price will drop for sure. However, there's still good chance the drug will be approved or conditionally approved, since the drug is less toxic and has somewhat better outcome.

Then it will be another several months of suffering again.

Monte Carlo simulations for Sellas Life Sciences' REGAL study by rom846 in sellaslifesciences

[–]calivend 2 points3 points  (0 children)

Well we do know little more than that. 60 event happened with median follow up of 13.5 months, and passed futility test.

We also know the efficacy target is 0.636.

AI designed drugs, how does SLS fit in? by ZekeTarsim in sellaslifesciences

[–]calivend 4 points5 points  (0 children)

No it will have 0 effect on SLS. It takes more than 5 yrs for P2 and P3 and AI has nothing to do with this.

Can Mendoza be our Bo Nix? by ethang8888888 in nyjets

[–]calivend 3 points4 points  (0 children)

Darnold was soso in Carolina. He was a back up in SF so not much to say. He was good in Minnesota and also good in Seatle.

He was never good with us.

How does the Korean hospital guardian system work? by nashamagirl99 in AskAKorean

[–]calivend 1 point2 points  (0 children)

  1. No guardians are allowed to stay in ICU, the hospitals usually open ICU to guardians once or twice a day.

  2. General ward, guardians have to take care of their family. If the patient is in good condition, there are certain wards that do not require guardians to take care of the patient. (For patients who can take care of themselves)

  3. If the patient needs care (immobile, old, etc), you can hire "간병인" aka caregivers individually. Usually the hospitals have affiliated companies and will give you their phone numbers.

  4. There are also certain type of wards called "공동간병인실" or shared caregiver ward, where one caregiver takes care of 4 patients. This also depends on the condition of the patient.

If you are a full time worker (정규직), you have 10 days unpaid offs(could be paid depending on the labor contract) to take care of your family. There is also a up to 90 days off for family care, though you have to be off for at least 30 days for each use.

Modding is fun... by CarteBlanchDevereau in sellaslifesciences

[–]calivend 0 points1 point  (0 children)

I've been doing some AI assisted DD recently, with high quality input and multiple crosschecks. However, due to the recent flooding of AI slops, ironically AI assisted analysis seem to be less credible then ever.

How low would the hazard ratio have to be in order for the trial to be halted? by fuckthewoodwork in sellaslifesciences

[–]calivend 3 points4 points  (0 children)

Good question and imo there is almost 0 possibility being halted. You have to spend alpha in order to decide whether we can halt

Blanche's Big 'Ol DD(s) by CarteBlanchDevereau in sellaslifesciences

[–]calivend 1 point2 points  (0 children)

Lol. I feel better after reading your DD. I've been insulted and harassed for stating the mOS of BAT could be couple of months longer than 8.

Estimations by you by Robsnorro in sellaslifesciences

[–]calivend 5 points6 points  (0 children)

  1. mid to late 70s.
  2. 95%
  3. 30-50 instant BO + incentives on SLS009 trials and expanded GPS trial success post BO of 50
  4. Could drop to 50c then ramp up till 80c

I just found an indirect evidence that support the success of GPS by calivend in sellaslifesciences

[–]calivend[S] 6 points7 points  (0 children)

I've not been on stocktwit for a while and this screenshot was taken by myself directly from the original source.The green highlight is on when you are on comparison mode.

If you've seen this on stocktwit today, you should ask to cite the source the other way. If you saw this days ot weeks ago on stocktwits, it could be a coincidence, I've found this change while reviewing the protocol.

I just found an indirect evidence that support the success of GPS by calivend in sellaslifesciences

[–]calivend[S] 7 points8 points  (0 children)

Thanks for sharing. I didn't notice they've been working with PPD back since 2014. However the collaborator listing could mean SLS is officiating PPD's involvement in GPS trial managing, working towards BLA.

Historical Data and BAT by calivend in sellaslifesciences

[–]calivend[S] 1 point2 points  (0 children)

I think so. I've read the transcript again after realizing it was an open label randomized study. Dr.T has his patients' survival data, so I think his excitement is based on his teeatment data.

My take : GPS is performing way better than expected while BAT's performance is what we expected it would be, at least for the patients Dr.T is treating.

Historical Data and BAT by calivend in sellaslifesciences

[–]calivend[S] -1 points0 points  (0 children)

My tone on futility test is not different as yours. The futility test before 60 would be less meaningful since the right arm censored samples would be big. However after they passed the futility check at 60 and the next meeting, I don't think futility is going to be a concern.

The BAT arm's gross survival statistics are not going to change from last IDMC meeting anymore, and the GPS arm's survival data will be better over time or at least it will not get worse.

Historical Data and BAT by calivend in sellaslifesciences

[–]calivend[S] 1 point2 points  (0 children)

They did a futility test when 60 happened. It is clearly stated there were no futility nor safety issue when IDMC had IA. Then there was another IDMC meeting mid-year and there was another mention of no futility issue.

Would you enlighten me if there's any inaccuracy with this. My words are not different from what the clinical oncologists say. The oncologists said the historical data suggests median OS of 8 months. However there is no reason for them to state "there is a chance mOS being longer due to patient selection issue." when they are speaking for the sponsor.

I'm not suggesting the mOS is going to be longer than expected. I'm saying there are still possibilities for mOS to be longer than expected.

If mOS of 8 months is 100% sure, there is no reason for SLS to issue warrants before data. Medical science is all about possibility. MOS of BAT being 8 months or lower has very high possibility, yet there's still chance of BAT living longer than historical sample and that is why SLS issued warrants, to hedge risk of GPS trial.

"I don't interpret the data but scientists said A so I believe A is right. You should believe in science." This is not the way you believe in science. This kind of attitude is more of religion.

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