Hmmm looking back over todays announcement & ANP's (09/09/15) was it the chronic toxicology study SBBP undertook in their unspecified animal trial and that's what shook them ? It wouldn't be the first time given that was Teva's exit also. Did they take that data to the FDA meeting ?
08/03/2016 -
"Strongbridge has also confirmed the completion of the manufacture of a batch of non GMP ATL1103 compound and has used some of this material in certain animal safety studies that it had initiated to support long term clinical development of ATL1103."
09/09/2015 -
"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 enablingchronic 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."
Hmmm looking back over todays announcement & ANP's (09/09/15)...
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