Cel Sci Corporation (CVM)

[Spideyboy]

In continuation of my just prior post on this end-point confusion, I found this on the Cel-Sci website.

http://www.cel-sci.com/multikine_phase_3_clinical_trial_design.html

"In April 2017, CEL-SCI announced that in light of new information CEL-SCI has decided to withdraw the study protocol amendment for additional patients that was submitted to the FDA and other regulatory agencies in the summer of 2016. It is now possible that CEL-SCI may not need to add more patients to the study or that only a smaller number of patients need to be added to the study to complete it in a reasonable period of time. Should additional patients be needed, CEL-SCI will submit a future study amendment to the FDA and other regulatory agencies to seek their clearance to proceed."

Thus if the logical calculations are correct, indeed Cel-Sci will need to submit a future study amendment for the additional patients needed. The worst thing about this is that that would mean that they might only start recruiting the extra patients once they have realised they need them, thus recruiting in 2020 at the earliest (assuming data in 2020). If this is the case, then we would need to recruit these new patients from scratch and then wait for the their 3 years to see if we can count them as events or not. Meaning waiting till 2023! oi veh!

Also something interesting I just noticed from the clinicaltrials website: https://clinicaltrials.gov/ct2/show/NCT01265849

Primary Outcome Measures:
Overall Survival (OS) in LI + CIZ + SOC vs. SOC [ Time Frame: 3 year ]
OS will be assessed using Kaplan-Meier life-table and compared using a logrank test and confirmed further with tumor stage location and geographic stratified log rank tests. The unstratified logrank test constitutes the primary analysis. A two-sided p-value of 0.05 or less will be considered statistically significant for comparing the two groups. Interim analyses will be performed throughout the study to assess safety, sample size and futility.

So this last line is either good or bad for us. 1. Good that these interim analyses have not sounded the alarm for futility yet. 2. Bad that Hold on a second! If it is a legal requirement as per the design that these "interim analyses will be performed" how come we haven't seen anything yet. Isn't it an offence to knowingly not-divulge information of this nature to shareholders? It is clearly highly meaningful as to our understanding of our investment.