+++ Trevena +++ Revolution in der Schmerztherapie? (Seite 175)

[Aktapot]

Antwort auf Beitrag Nr.: 58.947.915 von PESCADOS am 12.10.18 22:20:35

Diese präsentation dürfte kein Einfluß haben auf die fda Entscheidung.

[PESCADOS]

Nachbörslich nähern wir uns wieder der 1Dollar-Marke nach den News 😆

[fypet]

Antwort auf Beitrag Nr.: 58.947.759 von PESCADOS am 12.10.18 22:06:37

Zitat von PESCADOS: News Story
Search Company
10/12/2018 04:01:00 PM
Trevena to Present Phase 3, Open-Label Safety Study of Oliceridine at the American Society of Anesthesiologists Annual Meeting
By GlobeNewswire

CHESTERBROOK, Pa., Oct. 12, 2018 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN) today announced a poster presentation at ANESTHESIOLOGY® 2018, the national conference for the American Society of Anesthesiologists (ASA), taking place in San Francisco, CA, from October 13 - 17, 2018.

The poster presentation highlights data from a large, open-label safety study evaluating oliceridine under conditions intended to emulate real-world practice in hospital patients with moderate to severe acute pain requiring intravenous (IV) opioids across a broad spectrum of surgical and medical conditions.

"There are significant challenges with conventional IV opioids in striking the balance between finding effective pain relief and minimizing treatment-limiting side effects," said Harold S. Minkowitz, M.D., Associate Director, Clinical Research, Division of Anesthesiology and Perioperative Medicine, The University of Texas MD Anderson Cancer Centre. "There have been very few new analgesic options in decades. The data from this study suggests that oliceridine, if approved, may be an important new treatment option in lieu of conventional IV opioids."

Poster presentation: Sunday, October 14th

e-poster presentation (A2174): Athena: A Phase 3, Open-label Safety Study of Oliceridine for the Treatment of Moderate-to-severe Acute Pain. Scheduled to be presented on Sunday, October 14th from 10:00 - 10:30 am on Monitor #02 in the Convention Center room, North, Hall D, Area A, at the Moscone Center.
In the ATHENA open-label safety study, oliceridine was administered to 768 patients with moderate to severe acute pain caused by medical conditions or surgery across 41 sites in the United States. The trial included substantial representation of patients at elevated risk for opioid-related adverse events (ORAEs), with 32% of patients over 65 years old, and more than 50% with body mass index (BMI) over 30 kg/m2. Results of the trial showed that the safety profile of oliceridine, in a broader patient group, is like that demonstrated in the controlled Phase 2 and 3 studies of oliceridine.

About Oliceridine
Oliceridine is a G-protein biased mu-opioid receptor (MOR) ligand in development for the management of moderate to severe acute pain in hospitals or other controlled clinical settings and where intravenous (IV) therapy is warranted. It is a new chemical entity with a novel mechanism of action that enables more selective targeting of newly discovered pathways with the potential for fewer side effects. Oliceridine is an investigational product and has not been approved by the FDA or any other regulatory agency. If approved, the Company has requested that oliceridine be classified as a Schedule II controlled substance.

About Trevena
Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of new and innovative treatment options for patients in pain. The Company has discovered three novel and differentiated drug candidates using its proprietary platform, including intravenous (IV) oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the treatment of acute migraine, and TRV734 for pain and/or management of opioid dependence. In its preclinical programs, Trevena is evaluating a set of novel S1P modulators that may offer a new, non-narcotic approach to managing chronic pain.

Cautionary note on forward looking statements
Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of its therapeutic candidates, plans for potential future product candidates and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials, including whether the data from the ATHENA open-label safety study suggest that oliceridine, if approved, may be an important new treatment option in lieu of conventional opioids; the uncertainties inherent in conducting clinical trials; interpretations of regulatory interactions and expectations for regulatory submissions and approvals; availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements; uncertainties related to the Company's intellectual property; other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

Contacts
Trevena, Inc.

Investors:
Jonathan Violin, Ph.D.
Senior Vice President, Scientific Affairs & Investor Relations Officer
610-354-8840 x231
[e-mail]

or

Media:

Public Relations
[e-mail]



Source: Trevena Inc.
Quotes From This Article
TRVN$0.8779 0.0691 7.3%
Trevena, Inc.
Home
News
Quotes
Settings

Die geben nicht locker

[PESCADOS]

Antwort auf Beitrag Nr.: 58.947.759 von PESCADOS am 12.10.18 22:06:37

Cyberhexe, nicht schlecht,oder?😙

[PESCADOS]

News Story
Search Company
10/12/2018 04:01:00 PM
Trevena to Present Phase 3, Open-Label Safety Study of Oliceridine at the American Society of Anesthesiologists Annual Meeting
By GlobeNewswire

CHESTERBROOK, Pa., Oct. 12, 2018 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN) today announced a poster presentation at ANESTHESIOLOGY® 2018, the national conference for the American Society of Anesthesiologists (ASA), taking place in San Francisco, CA, from October 13 - 17, 2018.

The poster presentation highlights data from a large, open-label safety study evaluating oliceridine under conditions intended to emulate real-world practice in hospital patients with moderate to severe acute pain requiring intravenous (IV) opioids across a broad spectrum of surgical and medical conditions.

"There are significant challenges with conventional IV opioids in striking the balance between finding effective pain relief and minimizing treatment-limiting side effects," said Harold S. Minkowitz, M.D., Associate Director, Clinical Research, Division of Anesthesiology and Perioperative Medicine, The University of Texas MD Anderson Cancer Centre. "There have been very few new analgesic options in decades. The data from this study suggests that oliceridine, if approved, may be an important new treatment option in lieu of conventional IV opioids."

Poster presentation: Sunday, October 14th

e-poster presentation (A2174): Athena: A Phase 3, Open-label Safety Study of Oliceridine for the Treatment of Moderate-to-severe Acute Pain. Scheduled to be presented on Sunday, October 14th from 10:00 - 10:30 am on Monitor #02 in the Convention Center room, North, Hall D, Area A, at the Moscone Center.
In the ATHENA open-label safety study, oliceridine was administered to 768 patients with moderate to severe acute pain caused by medical conditions or surgery across 41 sites in the United States. The trial included substantial representation of patients at elevated risk for opioid-related adverse events (ORAEs), with 32% of patients over 65 years old, and more than 50% with body mass index (BMI) over 30 kg/m2. Results of the trial showed that the safety profile of oliceridine, in a broader patient group, is like that demonstrated in the controlled Phase 2 and 3 studies of oliceridine.

About Oliceridine
Oliceridine is a G-protein biased mu-opioid receptor (MOR) ligand in development for the management of moderate to severe acute pain in hospitals or other controlled clinical settings and where intravenous (IV) therapy is warranted. It is a new chemical entity with a novel mechanism of action that enables more selective targeting of newly discovered pathways with the potential for fewer side effects. Oliceridine is an investigational product and has not been approved by the FDA or any other regulatory agency. If approved, the Company has requested that oliceridine be classified as a Schedule II controlled substance.

About Trevena
Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of new and innovative treatment options for patients in pain. The Company has discovered three novel and differentiated drug candidates using its proprietary platform, including intravenous (IV) oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the treatment of acute migraine, and TRV734 for pain and/or management of opioid dependence. In its preclinical programs, Trevena is evaluating a set of novel S1P modulators that may offer a new, non-narcotic approach to managing chronic pain.

Cautionary note on forward looking statements
Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of its therapeutic candidates, plans for potential future product candidates and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials, including whether the data from the ATHENA open-label safety study suggest that oliceridine, if approved, may be an important new treatment option in lieu of conventional opioids; the uncertainties inherent in conducting clinical trials; interpretations of regulatory interactions and expectations for regulatory submissions and approvals; availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements; uncertainties related to the Company's intellectual property; other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

Contacts
Trevena, Inc.

Investors:
Jonathan Violin, Ph.D.
Senior Vice President, Scientific Affairs & Investor Relations Officer
610-354-8840 x231
[e-mail]

or

Media:

Public Relations
[e-mail]



Source: Trevena Inc.
Quotes From This Article
TRVN$0.8779 0.0691 7.3%
Trevena, Inc.
Home
News
Quotes
Settings

[fypet]

Antwort auf Beitrag Nr.: 58.944.081 von herthafan am 12.10.18 16:07:47

Ich kenne solche Entscheidungen aus eigener Erfahrung, arbeitete 18 Jahre für
ein Implantat Hersteller. Risiko-Analysen mit Behörden-Teilnehmer sind nicht immer Objektiv,
sie zeigen ihre Macht und ihre persönliche unwiderrufliche Einstellung.
TRVN wird in den nächsten Tagen um dem Market Cap von $65Mio. dahin tümpeln.

[Schaeffi]

hab meinen Durchschnitt auf ein Wert herunter gedrückt, den der Kurs
die nächsten Tage/Wochen vor der FDA Entscheidung nochmal erreichen könnte.

min 1USD bis 1,20 sollten möglich sein, vermute ich.

dann raus mit einem blauen Auge und gut iss.

So iss mal mein Plan

[curacanne]

Antwort auf Beitrag Nr.: 58.944.081 von herthafan am 12.10.18 16:07:47

fetternwirtschaft
Ich kenne nur Vetternwirtschaftobwohl fett dann sicher auch auf die gevetterten zutreffen dürfte

[herthafan]

.....protektionismus , zynismus , fetternwirtschaft , mauschelei und heuchelei sind eben die mütter der FDA......von koruption ganz zu schweigen........tut mir leid , aber bekannt auf der ganzen welt....!!!!!

[deRendite]

Unter https://www.mckinsey.com/~/media/McKinsey/dotcom/client_serv… gibt es eine Studie zu ACs und den letzlichen Approvals.

Interessant ist z.B. Seite 3. Wenn ich dort das mittlere Diagramm ansehe, dann sagt das, dass in 68% der betrachteten 63 Fälle ein klares "Yes" im AC rauskam und in 19% der Fälle ein klares "No". Das sind nach Adam Riese zufällig genau 43 und 12 Fälle, also genau so viele, wie Fälle in denen laut dem ersten Diagramm die FDA dem AC in der Entscheidung gefolgt ist. Angenommen, in allen diesen klaren Fällen ist die FDA dem AC gefolgt (ich weiß, das stimmt nicht ganz, aber meistens schon), dann würde das bedeuten, dass in ALLEN 8 Fällen, in denen das AC nur eine knappe Mehrheit für oder gegen die Zulassung hatte, die FDA am Ende anders entschieden hat, als die knappe Mehrheit empfohlen hat! Nochmal: Ich weiß, das gilt nur, wenn nicht klare "Yes" oder "No" Empfehlungen der ACs überstimmt wurden, was in der Vergangenheit auch passiert ist, aber eben nur sehr selten. Es gibt jedenfalls etwas Hoffnung!