@Andre_AGTC Agree and the only one of the group that is truly clinically derisked. CGON and FTH have EOY binary events. NRIX is a degrader play but their collab with Roche may have lowered their BO potential.
@bioinvestor24 I’ve been in this space for close to 30 years. There will not be an issue with coverage even with generics out there. The label is purposefully broad given the unmet need.
@Maximus_Holla Holding some lottos just in case they figure out a path with the FDA. The data are solid but approval of a combo without single agent approval will be the issue.
@Sanctuary_Bio It won’t end well. The problem in PPD is diagnosis….most patients are missed. I think HCPs will be hesitant to prescribe and prior auths will slow down the process.
@Andre_AGTC@Sanctuary_Bio Agree that agitation has been derisked but every indication/product beneath that is a huge ???. When 07 is finally approved in migraine there is no way that will be anywhere near 500M. CGRPs rule that space.
@Andre_AGTC I hope the FDA accepts the NDA. A few watch-outs, 1. FDA always questions post-hoc analysis of subgroups 2. I don't think type 3 was stat sig (p=0.053), but rather showed a numerical treatment benefit (which could still be clinically meaningful).