Avid Bioservices Inc (CDMO)

[nuke661]

WH,

I'm glad you posted this. I have had a lot of thoughts similar to yours today. If I might add a little.

It seems to me that one of the more significant purposes of having a control group is to assist in the removal of biases in treatment assignments and in treatment locations (skill of the craft so to speak and genetic/ethnic populations etc...).

It is my take away from the PR today and all the other news since Sept 24 is that this bias removal purpose of the control group has not been defeated/pierced/rendered useless - it is still intact and of great benefit. Pooling the control and 1 mg arms into a single control group allows the 3 mg arm to be a clean trial treatment group whose results should easily be compared to historical MOS data for the SOC used.

As far as using a control group to establish a "current" MOS for SOC I would think that after having used the SOC in numerous other trials (whose results have been posted here on the board several times) the importance and usefulness of the control group for this purpose (establishing current SOC MOS) would be diminished, and diminished to an extent proportional to the number of trials and number of patients in those trials using the SOC that we have used.

I don't see how the FDA can ignore the realigned trial data when the control group is "clean" for its very important purpose of reducing biases and we still have a "clean" trial group for the 3 mg and the industry has significant historical SOC trial data for 2nd line NSCLC control groups.

I can't see how the FDA could justify ignoring this data especially in this era of trying very hard to improve their ability to get new and improved and proven therapies approved. Especially when the trial data is such a significant improvement over historical SOC numbers. They have to take this data seriously in support of PIII.