Titan Pharmaceuticals Inc (TTNP)

[Doctor Detroit]

For anyone who gets nostalgic about past root canals, you can relive the fun of the Ad Comm at the FDA site. Interesting excerpt from the presentation of Beshad Sheldon (Braeburn's CEO):

"As we've reached agreement with the FDA's Division of Risk Management on the proposed REMS, we are providing this overview of the REMS on behalf of FDA as well."

So not only had the FDA agreed to the REMS in advance of the meeting, they allowed Braeburn to give their presentation for them. But a REMS issue comes up that delays the PDUFA? Too weird.




http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM500364.pdf