Has Heron started recruiting pain reps in anticipation of approval of HTX-011? Do you know which recruiting firm is handling it?
Yes, they are interviewing no and managers have just come onboard. This will be a contingent offer based on approval in April, so there is no risk if not FDA approved. Competitive base and Car Allowance. 80% of time deeply within hospital system so if you don't have access, it will not be a rewarding job.
So what’s the plan here with hiring for HTX011 launch THIS time around? Same as before, offer contingent on approval which again may not happen? Don’t think reps want to get burned twice.
For what? 1. Actual approval? Should be 6 mo unless boneheads in reg cmc screw up again. Maybe. 2. Offers for new reps? Why, because our crack mkt team STILL can’t get it together for a successful launch? What’s the strategy here flavor guy? 3. For Mgmt to get something right and sell this pig so we can all get out of here?
A protracted 2 month review is not the current expectation. BQ has been setting the base case as a 6 month review cycle which would suggest a late April/early May decision date. I guess we'll find out in a couple weeks. Also interesting to see that the FDA division that will be reviewing the application is hosting an Advisory Committee meeting in February to discuss the long-acting bupiv product from Durect which has had a bumpy history. Committee could easily add a second day to discuss HTX-011. Timing would work out perfectly, actually. Have to speculate that they were already thinking about the possibility of a two day meeting considering they moved back Durect's PDUFA date (originally in December) to host this Advisory Committee in February, a couple months before a potential PDUFA date for HTX-011. This division has had some notoriously critical and nit picky Adcom's in the past (just go ask our friends at Pacira). With all that's going on in CINV to boot, going to be an interesting next few months at Heron!
They didn’t do AdCom last time around, said only CMC issues, so would be major assholes to do one now. But I wouldn’t put it past them, anything to get in the way of innovation and progress and screw those suffering from opioid addiction too. Maybe BQ needs to handle this Dave Stack style and put them on the payroll.
I agree, I wouldnt say the probability of convening an AdCom this time around is 0% just because they didn't hold one during the first review. This division is wacky as all hell. In fact, it would probably make total sense if they did just that.
