My gut tells me that the FDA is going to request more data on the mTNBC BTD. With how they’ve been with the HIV trials, I think the shell game will continue. Hopeful I’m wrong, but with so few BTD’s given, data on 5 patients seems they will request more. If they do, hopefully only 10-20 max. IMO I think NP has heard back from the FDA about BTD. As has been discussed here, why would he have an update on BTD for the CC if he hasn’t heard anything? Additionally, if it were granted, he would’ve PR’d it in a heartbeat.
I think there will be some good news on the CC, and with some news on delays for BLA (sometime in March) and whatever hoops the FDA tells us we have to jump through to get BTD. Maybe he reads a few non dilutive term sheets and says, “we aren’t going to sign these” followed by a “BUT, we have signed this one” and he proceeds to tell us about it. Maybe I’m just dreaming... we shall see on Thursday.