Replies to post #106670 on Avid Bioservices Inc (CDMO)

[tradero]

WH, I absolutely agree with you. Common Sense should rule here.
I do not see FDA as a tough board that gives BIOs very hard tests to pass... just for the sake of being tough but rather as an Agency that should be there to help people fight diseases.
In a recent video (recommended on this Board) that's what they were stating. They were very aware that they would be held responsible for any unnecesary delays in approving breakthrough drugs.
Otherwsie what would be the reason of their recent "breakthrough drugs program"?
Any other worse disease than cancer? Another drug with better results (MOS) than Bavi?
of course IMO

[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.

[eb0783]

Wildhorses I totally agree with you: “While I appreciate all of this (and understand too much of it to be truly sane), I prefer the common sense approach.” I have felt the same way as all of this “noise” about hazard ratios, stat significance, etc over the last many months has distracted so many. Is it safe? YES Does it work? YES, people are living twice as long. That is all I need to know. I see very little risk as I buy and hold (I should say the risk v reward is unbelievably good). You have extensive business experience as you shared with us over lunch after the annual meeting, so I’m sure this “noise” makes you shake your head in disbelief. All we need to know is “Where’s the Beef?” PPHM has it!