Avid Bioservices Inc (CDMO)

[exwannabe]

Nuke, on your censoring issues:

My answer is "it is what it is and the numbers were generated using required FDA censoring methods by an independent medical review board and the resulting data for MOS is valid per FDA methodology".

You have 2 types of censors in a trial as such.

. If patients have been in the trial for say 6 months, then there is no data for months 7 and above. This will require the patient be censored at month 7, these are EOT, end of trial, censors.

. If the patient status is unknown (which would have to be because they can not be found), then they will be censored. These are the LTFU, lost to follow up censors.

There is no determination of anything else. If a patient is run over by a truck on his way for his first treatment, he counts as dead, not censored.

There would be no need of an independent review board to decide on these.

Do you have published information such as FDA guidance or reports or any industry reports that would show that the censoring numbers in the PPHM trial data is an aberration or represents data generated in some type of non-professional and/or deceitful manner?

The number of LTFU censors early in the trial seams to be on the high side compared to other OS studies I have seen, but I will not make a claim that they are off the charts. The cause though simply does not matter, one would rationally expect the LTFU patients to be doing worse than the others, so there would be a bias in the stats.

I have tried to find an FDA document dedicated to the subject of censoring that would provide clear guidance on this matter but I have not been able to find one.

Since censors include both EOT (which are normal and can be quite high) and LTFU censors, the number means little. I wuld not expect any FDA guidance on this. They might have some comments on LTFU if you search around for that, but even then it will probably be general as this will vary. The FDA would certainly accept a dataset with censors such as this, but might look into the early LTFUs. Might be an interesting search going through FDA breifing docs for ODAC and see if the subject ever comes up.