Nehme an Trevena wird es mit ihrem Oliceridine schwer haben.
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“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.”
... also keine Sorgen machen - Shares Dilution
https://www.ariva.de/forum/...company-69-67-527717?page=17#jumppos436
11.10.18 76.08M
Shares outstanding as of November 2, 2018: 82,323,413
https://ih.advfn.com/p.php?pid=nmona&article=78647157
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Wertung | Antworten | Thema | Verfasser | letzter Verfasser | letzter Beitrag | |
6 | 916 | Trevena - biopharmaceutical company +69,67 % | Balu4u | Dölauer | 19.07.23 17:35 | |
Nach dem Split | Dölauer | 11.11.22 12:44 | ||||
176 | Trevena FDA 2018 Olinvo | OlliCash | joker75 | 25.04.21 00:44 |