Replies to post #112437 on Avid Bioservices Inc (CDMO)

[Protector]

KT,

First,my recollection was that PPHM was indicating that it was the 1 mg/kg arm that was showing stat sig relative to the control arm. The post you were responding to suggested it was the Combined control arm that was stat sig, which is something that I don't recall PPHM has addressed in their communications.

No, I have always been under the impression 3mg wasn't stat sig, 1mg was, and for the combination I actually never gave it a thought.

My call out is that the MOS can indeed get better by showing longer survival for censored patients that event than survival indicated by an interim result

We have no discussion on that point, you are correct for the final MOS, but notice the bold part. I may have worded it bad, but "on 50% passing away" is actually the interim results MOS.

[investingdog]

<< My call out is that the MOS can indeed get better by showing longer survival for censored patients that event than survival indicated by an interim result-- if censored patients event over time where there are more patients that event "to the right" of the interim MOS value than to the left >>


Correct. Furthermore one can argue that the 3mg Bavi patients that were censored last time they announced MOS in September were the ones that were still alive at that time and living longer than average for the arm, and if/when they event it is likely to push MOS to the right. Same goes for combo of 1mg Bavi plus placebo arms but to a lesser degree. IMO final MOS for 3mg Bavi will move to the right, and 1mg Bavi plus placebo combo may also move to the right but less than 3mg arm.

[Protector]

To KT and other board members following the MOS discussion!

I have spend several hours understanding why we have this MOS discussion because I knew for sure the maths were correct. I then finally found it was not in the maths but in this phrase of KT which I have not given sufficient attention:

As you noted, patients shifting their status from censored to evented can shift the MOS for the trial arm.

In everything I have been posting about this topic I have ALWAYS assumed that when a patient gets censored that patients is kind of technically out of the trial. His results are not counted because there is a reason why he has been censored.

As a consequence there is/was no way that the MOS could EVER improve after the 50% HR cross. If it is correct that for the MOS correction censored patients DO COUNT and the number of months they survived is added to the MOS series then they can be added to the left as well as to the right of the current median in which case the median can shift to the right and can improve.

If this is so then I have been overlooking that possibility. All posts are correct except then for the statement that the MOS cannot improve (become better). I appolagies to the board for that mistake if such is the case. Ironically, as a positive posters I will then have kept an argumentation that the MOS could not improve, while when me being wrong it can, which certainly add to the fact that I do not try to suppress any negative information as I was myself the source of a more negative outcome then the one which comes into line when I am wrong.

That being said, just as I raised some questions about the validity of not assigning ECOG groups in a more balanced way over the arms, I do have my questions about including censored patients into the MOS series. I some case we'll even won't know what became of these patients and if they where censored they where so for a reason so why must their results be disqualified and their death being included in the MOS! But that is another discussion.

Again, if censored patients reenter the clinical trial when they pass away then the MOS can improve and I was wrong saying it could not. Let this be the good news to start the day :)