Trevena Inc (TRVN)

[danti]

GOT SCREWED AGAIN, DIDN'T GET THE CHANCE TO SELL IT 1.22 THIS AM...BC OF THE HALT AT 7:29 AM!!

BAD LUCK WITH THIS POS MORE THAN TWICE!!

A conference call and webcast will be held on November 5th at 8:00 AM ET. To join the call, please dial in at [phone] (conference ID: 5489646).

https://www.streetinsider.com/Corporate+News/Trevena+%28TRVN%29+Receives+CRL+for+Oliceridine+from+FDA/14779362.html

Trevena, Inc. (NASDAQ: TRVN) today announced the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for oliceridine.

“While we are disappointed with FDA’s decision, we continue to believe in the strength of the data and the ultimate approvability of oliceridine,” said Carrie L. Bourdow, President and Chief Executive Officer. “We plan to schedule a follow-up meeting with FDA as soon as possible with the goal of bringing this important medicine to clinicians and hospital patients.”

Consistent with the discussion at the recent Advisory Committee meeting, FDA has requested additional clinical data on QT prolongation and indicated that the submitted safety database is not of adequate size for the proposed dosing. FDA also requested certain additional nonclinical data and validation reports.

“Developing a novel chemical entity is complex, and we believe the data we have to support oliceridine advances the pharmacology of acute pain therapeutics,” said Mark A. Demitrack, M.D., SVP and Chief Medical Officer. “We were encouraged by the discussion at the Advisory Committee meeting and look forward to continuing a productive dialogue with FDA.”

A conference call and webcast will be held on November 5th at 8:00 AM ET. To join the call, please dial in at [phone] (conference ID: 5489646).

To join a live audio webcast of the call, please visit the Investor Presentation section of the Company’s website (conference ID: 5489646). Following the conclusion of the call, the webcast will be available for replay for 30 days.