Replies to post #32387 on Cel Sci Corporation (CVM)

[GD]

25% OS advantage is a blockbuster homerun, and 48%-52% SOC OS
is a grand slam, may be too good to be true, guarantee CVM going
over $100+ the day topline PR, IMO.

[Biobonic]

A look behind the numbers in the prior post


A couple of examples: High improvement: 8% dropout and SOC OS of 48%

398 per arm. 8% dropout=366 per arm

SOC OS of 48% equates to (52% deaths of the 366 is 190 in SOC arm)

With 298 total events, leaves 108 deaths in the MK arm.

OS improvement based on those living:

SOC: 366 less 190 deaths leaves 176 living

MK: 366 less 108 deaths leaves 258 living

MK arm: 82 more living than SOC: 82/176= 48% improvement.



Example: Low improvement: 12% dropout and SOC OS of 52%

398 per arm. 12% dropout=350 per arm

SOC OS of 52% equates to (48% deaths of the 350 is 168 in the SOC arm)

With 298 total events, leaves 130 in the MK arm.

OS improvement based on those living

SOC: 350 less the 168 deaths leaves 182 living

MK: 350 less the 130 deaths leaves 220 living

MK arm: 38 more living than SOC: 38/182 = 21% improvement

[Proxima]

This is exactly my main worry about this CT.

Quote: "124 can drop out or 15.5% and still meet the trials original design for statistical power. "

In a SEC filing 11/30/2015 Cel-Sci stated: "About 100 of these 117 patients enrolled during the tenure of the former CRO as the global manager of the Phase 3 clinical trial will likely not be considered to be evaluable subjects at the close of the study. "

How will these patients be treated in the analysis?
If the IDMC did their job I guess this is a moot point, they recommended the study continue post 2017 several times. I know some people have pressed Gavin and he stated they WOULD be included in the analysis, though that could mean other things than "evaluable". Just wish the clarification had been done in a SEC filing rather than a statement by IR.

We'll find out in the next few weeks.
Best wishes!