Cel Sci Corporation (CVM)

[Spideyboy]

10% improvement was considered for each of the 2 groups of radiotherapy and chemo/radiotherapy individually over respective SOC group. Please feel free to review the call from minute 3 to minute 5.
https://frugalnorwegian.com/cvm/

Thus the 14.1% absolute improvement in the radiotherapy group is valid for meeting the Primary Efficacy Endpoint for this group as mentioned by the statistical analysis group in their letter that was read out and stated for clarity as being met.

I have just posted a post with the OS results break-up of the (MK+Surg+Rad Vs Surg+Rad) as you say in the low risk treatment arm using the information provided on the call and little bit of logical mathematics from the randomisation, please read it.

It took 6 years (2011 to 2017) to enroll the 928 patients in the largest head and neck cancer study in history, some months enrolling at record rates of 30+ patients/month, and you are saying that it is not enough?? You state needing thousands, so just to reach 2,000 you expect a company to spend 12 years enrolling patients? While CVM was enrolling from 78 different sites in 24 countries on 3 continents. Even with significant more investment in would take minimum 10 years to reach 2,000 enrolled patients, and obviously many more years to reach 3000 if that's how far your 'thousands' goes. For sample size it is not simply about the enrollment numbers but about the ability to observe the requisite p-value on the endpoint which was clearly met at p=0.0236. Clearly your premise is ridiculous in light of the relevant patient population and resulting OS efficacy seen in the radiotherapy groups.

Not only that but the 163 vs 163 radiotherapy groups with a p-value of 0.0236 clearly demonstrates the significant difference attributable between the 2 radiotherapy arms as this is p-value is very much considerably lower than the required p=0.05. Mathematical Statistical benefit was categorically demonstrated for the primary efficacy endpoint in radiotherapy patients.