Replies to post #2316 on Revance Therapeutics Inc (RVNC)

[stugwins]

CBE-30 (most likely). The protocol gets submitted to the FDA. You wait for 30 days and if you don't hear back you implement.

I know of cases where the whole cell line (i.e. Master Cell Bank not only the Working Cell Bank) was changed and the changes were done under a CBE-30.

CBE (less likely). You can start implementing upon submission of protocol to the FDA and don't have to wait at all.

All in all, an experienced and competent team should take care of this in a matter of a few months.....

[stugwins]

One could assume the FDA got pissed off because they implemented a change without the comparability protocol (Observation 2). They should have submitted a CBE at a minimum.