After listening to the recorded webcast, I understand somewhat where you guys are coming from.
Some heard SK's "in a few years", some probably heard Jeff's "[SUNRISE] close to approval".
Really, it's vague until it's not. It's a small biotech until it's not.
Garnick really shines though. Garnick to the BOD! Very good public speaker (he has to be). What I've liked:
* Wants the same document but with bevacizumab replaced to bavituximab.
* Gives credit to Shan for executing on Phase III.
* Trials are in developed countries. China and India would be questioned by everybody.
* Nobody knows the mechanisms of actions 100%
* Bavituximab good is that it's safe and we know the dose. Many others don't, even in Phase III!
* Defending the submission is hard work.
* FDA approval letter will contain the manufacturing site: "in our case, it's Tustin"
* Fast Track is tremendously important.
* OS is an extremely clear endpoint in terms of approval.
* Standard (2+10 months), Priority review or BTD. E.g. Nivolumab submitted BTD after Phase III.
* You don't wanna have RTF - Refuse To File within 2 months of submission.
* "What I think is the Holy Grail, is the Priority Review" - 2+6 months.
BLA and MAA are submitted, wait 60 days, decide whether accept or not, pre-approval inspection of facilities. Issues have to be resolved before drug is approved. First-class manufacturing has to be in place.
* Since it's a single Phase III trial, ODEC committee meeting with 8-10 FDA-appointed physicians most likely required. Garnick been on 3-4 meetings. An intense public meeting, preparation is 4 months. Meetings are a torture. They are very emotional. Dr. Shan will answer the questions. ODEC decisions are not binding, but FDA 80...90% goes along with the committee.
