Rebound-Chance nach verpassten Phase-3 Studienzielen

[DomRuinart]

NERV: Roluperidon als Monotherapie für Schizophrenie vor Zulassung?

4,6 Millionen float, 1,6 Millionen short, SI über 34%, CTB über 81% (Quelle: Fintel.io)

Das Unternehmen beantragte am 22. August die Zulassung für Roluperidon bei der FDA.
9 $pro Aktie in cash! (Quelle: NERV Inverstot Relations Website).

Ich probiere hier mal eine kleine Position...

[Schumlim999]

Booooom 🐒

[Malecon]

Heute ging's bis $ 3:





Dann versperrte die drückende Kante den Weg.

🎵

[Malecon]

Bei Minerva Neurosciences Inc hat der MACD im Daily die Signallinie nach oben gekreuzt.





💡

[Aljo]

Antwort auf Beitrag Nr.: 65.943.147 von ooy am 04.12.20 06:46:37

Sollte die Äquivalenzstudie positiv ausfallen sehe ich weniger Probleme (natürlich wäre es schöner gewesen das nächste Wundermittel auf den Markt bringen zu können), ansonsten halt nochmal P3, das war aber schon bekannt. Ist halt bisschen wie zocken, deshalb auch nur überschaubare Beträge im Einsatz 😎.

[ooy]

Antwort auf Beitrag Nr.: 65.941.389 von Aljo am 03.12.20 21:20:03

Viel Glueck, ich sehe das eher negativ.

Minerva Neurosciences Announces Outcome of Type C Meeting with FDA and Next Steps in the Development of Roluperidone Nachrichtenquelle: globenewswire | 01.12.2020, 14:00 | 217 | 0 | 0 WALTHAM, Mass., Dec. 01, 2020 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that it has received official meeting minutes from the November 10, 2020 Type C meeting with the U.S. Food and Drug Administration (FDA) regarding development of roluperidone for treatment of negative symptoms in schizophrenia. The objective of this meeting was to obtain FDA input regarding the roluperidone data package and its readiness to support a New Drug Application (NDA) submission. The two main topics addressed during the meeting were: Anzeige Ausblick auf 2021 PULLACH (DJE Kapital AG) – 2020 löste Corona den schärfsten Börseneinbruch weltweit in der Wirtschaftsgeschichte aus. Er traf die Welt in einer verletzlichen Situation, in der sich die Konjunktur bereits international deutlich abschwächte, so dass die Pandemie den bestehenden Abwärtstrend noch einmal massiv verstärkte. Mehr erfahren powered by finative 1. Readiness for submission of NDA Minerva requested confirmation from FDA that, based on the totality of evidence, the data from the MIN-101C03 (Phase 2b) and MIN-101C07 (Phase 3) studies constitute substantial evidence of the effectiveness of the 64 milligrams (mg) dose of roluperidone for the treatment of negative symptoms in schizophrenia and would warrant review of an NDA submission. FDA advised that the Phase 2b study is problematic because it did not use the commercial formulation of roluperidone and was conducted solely outside of the United States. In addition, FDA commented that the Phase 3 study does not appear to be capable of supporting substantial evidence of effectiveness, because neither dose of roluperidone showed a statistically significant separation from placebo at Week 12 in the intent-to-treat (ITT) analysis set. FDA cautioned that an NDA submission based on the current data from the Phase 2b and Phase 3 studies would be highly unlikely to be filed and that, at a minimum, there would be substantial review issues due to the lack of two adequate and well-controlled trials to support efficacy claims for this indication. FDA acknowledged that the data from the Phase 2b and Phase 3 studies appear to show promising signals and encouraged Minerva to continue the development of roluperidone for treatment of negative symptoms in schizophrenia, which FDA confirmed is an unmet need. Minerva recognizes FDA’s comments but believes they can be addressed based on published regulatory guidance and precedents. The company has comparable pharmacokinetic data for the formulations used in Phase 2b and Phase 3 (the commercial formulation) and intends to perform a pivotal bioequivalence study to bridge the two formulations. In addition, Minerva believes the Phase 3 study has shown that US data and ex-US data are comparable, and that many precedents exist where drugs were approved by FDA based solely on ex-US data. Minerva believes that, in the Phase 3 study, results from the modified ITT (mITT) analysis set that excludes patients with implausible behavioral and physiological data from one site (17 of a total of 513 patients) address the lack of separation at Week 12.

Minerva Neurosciences Announces Outcome of Type C Meeting with FDA and Next Steps in the Development of Roluperidone | wallstreet-online.de - Vollständiger Artikel unter:
https://www.wallstreet-online.de/nachricht/13220187-minerva-…

[Aljo]

Antwort auf Beitrag Nr.: 65.914.311 von ooy am 02.12.20 07:07:19

Hab noch 2 Orders drinnen 1x bei 1,80$ und bei 1,15$ schauen wir mal.

[Zwenne]

Also ich bin wie gesagt gestern bei 2,92 $ eingestiegen.
Danach ging es bis 3,02 hoch und AH noch auf 2,89 runter. Jetzt aktuell im Pre bei 3,05 $
Risiko ist es in jedem Fall. Das muss jeder für sich selbst abschätzen.

[ooy]

...und jetzt?
Sollte man es wagen??
Was meint Ihr??

[Zwenne]

Meine natürlich 2,92$