Replies to post #28749 on Cel Sci Corporation (CVM)

[lightrock]

What assumptions did you make to run a kaplan meier ?

That seems going too far with what can be known

[lightrock]

Also, can you elaborate on this ? It seems rather far fetched that less than half of all possible events come from the SOC, where unless there is toxicity, this number must be 150 at an absolute minimum.

3. Re: Fosco's Model, if there were 162 event in control by Sept 2019, there are probably 109-126 events in the SOC as per his model, dividing the two number (assuming 1:1 randomization ratio) yields a HR in 0.60s-0.70s range, idk how you were able to derive 0.84.

[lightrock]

To be sure...

3/7ths of the total enrolled are test
3/7ths of the total enrolled are control
1/7th is auxiliary and not compared

That means the total enrollment between test and control is 794

[przgwxl]

@ZS: I agree on the stopping criteria. I needed to go deeper. I do think the correct interpretation confirms that the trial would not have been stopped early for efficacy. Is there anything else to be gotten from this view?

For instance, if Cel-Sci/SEER survival statistics are assumed for the control arm, then the hazard ratio now is around 0.5. It was unlikely to be much different last October. If MK is generating that size of effect, why would the trial have not been stopped in October?

On the hazard ratio, I likely mis-computed.

Sorry for all the confusion. I would be interested in the answer to the question, may give a hint of the likely range to treatment effect. I did point to a paper in a previous post that pointed to a very large treatment effect when the ratio of CD4/CD8 leukocytes was adjusted by a treatment, exactly the impact Cel-Sci believes MK would have. I just don't know if this is possible given the results of the interim analyses.

I'd think the IDMC recommendation would be independent of Cel-Sci's desire to continue or stop the trial, so when the IDMC says continue I assume stopping criteria have not been met.