Avid Bioservices Inc (CDMO)

[exwannabe]

The rolling submission does not change the PDUFA date, but would help to avoid a minor delay on a CMC or pre-clinical issue (which presumably would be the early sections submitted).

But the clinical section submission must be a single filing. And can not be until after they have the data.

I would tend to think a submission of the complete BLA by end of '17 would be a reasonable target (though of course with an event based data cut one can not "hope" for it being on time).