NorthWest Biotherapeutics Inc (NWBO)

[iwasadiver]

That’s a big bite to take on Umibe, but let me read through your questions again and see if I can shed some light.

I will tell you this: when you look at the current state of the universe, and see how the internet has connected us to allow us all to delve into the minutiae of everything you’ll find that sometimes that minutiae causes one to feel things are more complicated than they need to be.

I do believe the SAP is being done pretty much in the way you surmise. If you look, for example, at the Keytruda Study application to the EMA for a variation to include use for the treatment for head and neck Squamous Cell Carcinoma to the indications already approved for NSCLC it will make your head spin. In that application they noted that:

“Overall, the statistical analyses proposed in the protocol are considered adequate. However, the protocol was amended several times and the changes have HEAVILY MODIFIED THE STATISTICAL COMPONENT OF THE STUDY DESIGN (definition of primary endpoint, stratification factors, follow-up duration, unplanned crossover) and sample size, and therefore have influenced the conduction of the study, having implications for the clinical interpretation of the results.”

They did additional sensitivity analyses on several of the factors that they found that appeared may influence the OS. In the first few months of the study the death rate was actually greater in the treatment group than the control so they did analyses to see what factors may have been present to cause this. They also had to do sensitivity analyses on people that crossed over to other treatments after progression (ones outside of this trial). Additionally they used a supportive analysis using something called Restricted Mean Survival Time to show that PFS, which was not statistically significant at the Mean, did indeed separate and increase in favor of the treatment arm over time.

So, the statistical analysis has been a moving target in immune therapy trials, and all the hubbub concerning NWBO’s SAP is nothing but blather to throw off people who can’t find the time or have the skill to read through all of this. It’s confusing as hell, and it takes a lot of effort and time.