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Re: Closewatcher post# 2633

Friday, 07/28/2017 1:39:59 PM

Friday, July 28, 2017 1:39:59 PM

Post# of 6315
NB1222 is a prodrug, so it will likely need a phase 3 trial (source: your link). Phase 3 trials are never small. Approval will still take several years, and dronabinol/nabilone (for CINV) are only approved as last line treatment options meaning they are only prescribed when patients fail to respond to conventional antiemetics. NMUS needs to license NB1222 (or in-license unfortunately), and that doesn't require an NDA.

I didn't know until I read your link that 505b2 pre-ind meetings occurred before formulation development. I don't remember NMUS mentioning that they had completed a pre-ind, but I guess they did. Seems like something that would be in a presentation or part of a pr.

Anyone else notice NMUS mistakenly referred to NB2111 as NB2222 in their last pr?