Replies to post #75932 on Avid Bioservices Inc (CDMO)

[honestabe13]

Dog..."let them take their time"?????

what's another 10 years...

[jonnyrocket]

I agree that what you say could very well be what the holdup is, and I just as much agree that the FDA may have some issues with the India outlier data and why the India data was twice as good as the entire data. Maybe it's just catheter placement and the India Doc is that good. I just have no idea, and keeping in mind PPHM past history, I give your take on the situation and the above scenario equal 50/50 odds.

[entdoc]

rrdog,agree. freemice, yes!betabodies. I share your enthusiasm.

[Robert C Jonson]

Since this can not be a randomized, placeboed trial which is the gold standard

It can't even be a blinded trial, it seems to me, since if a patient gets a hole bored in his skull, he'll be getting Cotara. It is a dilemma for the FDA, I would imagine whether they'll be able to approve a drug based on an open-label trial.