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Dr Bala

05/03/21 1:57 PM

#374160 RE: AVII77 #374158

Now this is better that you provided a table from the paper itself without commentary. This paper has been quoted in numerous subsequent articles by experts in the field. These articles didn't report problems in the selection criteria.

sentiment_stocks

05/03/21 5:40 PM

#374254 RE: AVII77 #374158

And yet, the point you are making isn’t supported by the chart that DCVax-L figure 1. that you cite. Out of almost 1600 patients, only 41 (3%) were too sick to meet the trial criteria and enroll, and 250 (16%) were either REP or pseudo-progressors, both types of which did not fit the criteria of the trial. If we split 16% down the middle (which seems a fair split as we don’t know who were what), that would mean that 8% were excluded because they were rapid progressors, and the other 8% were excluded as psPD.

I don’t think many would agree with you that the majority of those excluded were for the reason of disease progression, as 11% (3 + 8%) hardly represents a majority of those who were excluded-during-screening patients.

Most of the comparable trials also removed rapid progressors, and often-times, kept the psPD (who you’ve insisted are thought to live longer) in their trials. You, in fact, have many times argued that there were psPD patients in the main arm of the trial, despite the screening pipeline designed to prevent their entrance, and it was for this reason that the DCVax-L trial patients were living longer. And yet, now you can see from the TMJ figure 1 you cite that the pseudo-progression patients were indeed excluded (per the protocol), along with the rapid progressors.

What we can be fairly confident about is that given the list of excluded patients, the DCVax-L trial removed those patients who were likely to live the shortest of times (the REMs), and those who were likely to live the longest of times (the psPDs).

From there, the rest of those patients excluded has nothing to do with disease progression. Therefore, the DCVax-L P3 patients should be easily matched to patients with the same or similar criteria present in most of the other GBM trials (except, again, many of them included the longer living pseudo-progressors, which the DCVax-L trial did not).