Avid Bioservices Inc (CDMO)

[bimerkjaere]

Nice post ftm, and just to add that the FDA does not require a placebo controlled IIb to move into phase III testing in NSCLC. Meaning, even if the FDA discredits the new 'control' arm of 1mg/placebo mix, the 3mg arm results of 13+ mo of MOS compares very favorably to the historical average MOS for docetaxel in 2nd line setting (7-8 mo), granted it is a small sample with just the 3mg treatment group.

Still, with an unaltered, clean 3mg treatment arm, I think bavi gets the green light to ph III trials, and a BP should be quick to sign once the go-ahead is given. However, FDA may want to see 1mg and 3mg tested in ph III to ensure 3mg is correct dose.

IMO