It has been very well established through multiple credible and governmental sources that no interim efficacy analysis was performed (thus reserving alpha), nor ‘efficacy peak’ at least up to the court information from 2017.
We both know that when regulatorS put the August 2015 halt in place what they did was halt new screening, not new enrolling. We also know that placebo in the final 31-32 people was removed.. this likely had been discussed with FDA as evidenced by the 2017 JTM article demonstrating an imbalance. This publication would have to be cleared with FDA or suffer severe potentialities which no attorney would do. This is evidence of another time point of communication with FDA BTW IMHO. As the study was allowed to continue in 2015, we know with certainty that the halt WAS NO DUE to DRUG SAFETY. Later publication confirmed an extremely low AE rate. As nee patients were added to treatment in 2015, this proves that no manufacturing problems had occurred. After March 2017 we can follow a blinded grouped cohort through time on he Kaplan Meyer Curve later posted in 2018. Key word in that sentence is BLINDED. The only reasonable question as to whether they remain truly blinded comes in NOV 2018 when we see likely OCT 2018 results as it allows one to follow that 32 patient cohort, however, those individuals remain completely deidentified to the company, themselves and their physicians. They are blind technically and effectively. In November 2018 they publicly state that they are beginning the process towards locking the database. This means that when they began work on the SAP they were blind and negotiation with FDA and other regulators as to the future course of data analysis in a mandated alteration to the original study design that clearly has a negative impact on treatment benefit determination.
Now the question that some may have, but I do not, is whether no more placebo means no more new randomized placebo patients or whether no more means no more… it means no more. This means between August and probably November all existing placebo patients were transitioning to treatment. It is unethical to use placebo per The DSM.
Comparing data from 2017 to 2018 may allow me to speculate with a high degree of certainty the results of those treated with DCVAX-L before progression, but I do not have a good comparison group because it is at least 2/3 mixed with treated patients of which more than 70% likely received DCVAX before progression. DSM already determined an impact on mortality back before AUG 2015 when regulators forced the removal of placebo thus implicitly establishing efficacy and not only obliged to accept SAP changes to efficacy analysis but also learly demonstrating support for the products efficacy. I contend FDA has been working with us all along, not against us as some dribbling typetwisters may suggest.
AI
