Replies to post #18454 on Cel Sci Corporation (CVM)

[yankeesnyc27]

When was the last P3 patient treated???

ANSWER: Late Sept. 2016. Wasn't that 29 months ago???
SOO,anyone think there are issues going back that far??? AND the FDA has made zero comments in that time???

To the best of my recollection; P3 patients that expired within their first 6 months were excluded from the trial.
AFTER 6 months cause of death is not a factor..... it's mortality between the TWO groups that the FDA will evaluate.

The FDA assumed that would/could happen and actually required LESS than 880 patients.
My recollection was 11% (880-96=784 ).

The FDA is in charge of the P3, NOT a CEO, NOR message board posters.

I was beginning to wonder if the P3 ends after 298 spread sheets.

Per the FDA the P3 is OVER ,COMPLETED.

BTW : The P3 patient tally is posted ( EXCLUDING the first CRO patients.)

[Fosco1]

Hi
I am not so worried about people dying from another disease during the trial as this is already factored in our models, and that’s why we talk about “relative survival” VS “overall” or “observed survival”.

All the models compare:

1) The observed survival curve from the figures we know or assume from Cel SCI IT-MATTERS clinical trial (knowing the dates of enrolments – know some events dates – and assuming an end of trial date to reach 298 deaths)

VS

2)The Standard of Care survival curve.

This SOC curve has to be based on “overall survival” statistics to be able to be comparable. We can use for instance data from SEER DB, but most of the time they provide relative survival stats so one needs to adjust them.

The following link is interesting because it gives a hint the relationship between both :
relavive survival

(All phases observed survival is 56% and relative 65%)

The more we wait with no news, the more this analysis looks good as this shows that 1) is much better than 2)

So, my question is about the “evaluable” patients. If you remember well, 2 patients from the 21 had not HNSCC in phase II trial. Also Cel Sci was often mentioning 780 evaluable patients VS 880 enrolee

So if 298 events is related to the 794 patients from the 2 arms we are looking at (The third arm which accounts for 1/7 of the total 928 not being considered for the primary endpoint) the survival is currently really good after all these years : 497 survivors / 794 = 62%, far above any SOC statistic

But if 100 patients out of 794 were disqualified during the course of the trial because “not evaluable” (I am not saying those who died of other cause during the trial), then the 298 observed (not relative) count as counted by Cel Sci relates to 694 and then the survival is 396 / 694 = 57%. Slightly less than before.

I guess that’s another 10B $ question ??

Have a good day

Fosco