Replies to post #39505 on Cel Sci Corporation (CVM)

[lightrock]

The 5% thing in our case is bolstered by lack of effectiveness of placebo in cancer studies.

Our 5% is not confuse-able with placebo effect

14% at year 5 is 2/3rds of a year added lifespan on average to that population

For immunotherapies that's not 1-3 months, that's substantial - especially into and beyond year 5

... people are alive today that probably wouldn't be otherwise ...

[mikedel]

PlanTrader excellent post and assessment.

The logical answer to why the lack of full discloser is that the subgroup data does not support their claim due to insufficient data points.

Recent FDA statement to another company with similar situation:

"Subgroup analyses have well-established limitations, especially in the context of a clinical trial that has failed to show a benefit in the overall study population. For example, subgroups are often small, and therefore imbalances are common. Analyses must meet statistical significance when using established and reliable analytical methods that correct for multiple comparisons. However, as noted above, such analyses may inform the design of future clinical trials. If company plans further studies to determine whether the drug can provide clinical benefit to individual, FDA will continue to provide advice to the company on their development program."

Unlike CVM, This other company provided all critical detailed data to the public and FDA prior to any publication. This was all done expeditiously within ~1 week after reporting.

Due to the criticality of company survivability, Geert will only report supportive information to maintain SH interest and ability to acquire future funding. Expect a long drawn-out publication submittal period prior to reporting details to FDA and public. This is a strategic company decision to delay and NOT required by publisher. Delay tactics to keep the dream alive is consistent with Geert's approach on other studies that ultimately failed.