Avid Bioservices Inc (CDMO)

[jbainseky]

For those who don't believe the FDA had anything to do with approval, or the trial design etc. Look at this presentation, and yes, I realize at the beginning it says it isn't FDA guidance, but it is from the FDA site.

And for those who don't fully appreciate what the mis-labeling in the phase 2 trial really did, look at slides 48 through 52, especially the first bullet on slide 51. No doubt we were on the verge of AA, and it is still a possibility based on slide 6, but have to admit, probably unlikely due to the mis-labeling!

http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ucm103366.pdf

JBAIN