Actually Coming up to 4 months since SB engaged the FDA although the initial contact is likely even further back. Nearly three weeks since ANP politely asked SB WTF is happening with a licencing agreement they signed 10 months ago? Has the review cycle started and where in the review cycle are we? Also what is happening with all the other activities that are suppose to be happening in parallel?
From 9/9/15 - This ATL1103 higher dose study being undertaken by ANP will run in parallel with other activities to be conducted by its licensing partner, Cortendo AB (now Strongbridge Biopharma plc). These activities include seeking orphan drug designation from the FDA and the EMA, the conduct of Phase 3 enabling chronic toxicology studies and a pre-IND meeting with the FDA in the second half of 2015 to discuss requirements for entry into Phase 3 clinical development.
Strongbridge - partner or predator?
Actually Coming up to 4 months since SB engaged the FDA although...
-
- There are more pages in this discussion • 32 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
