On January 4, 2017, we announced that, based on an analysis of top-line data, the confirmatory Phase 3 clinical trial of Macrilen™ (macimorelin) failed to achieve one of its co-primary endpoints. On January 30, 2017, we announced the completion of the clinical phase of the pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) study with the occurrence of the 384th death On February 13, 2017, we announced that, after reviewing the raw data on which the top-line data were based, we had concluded that Macrilen™ (macimorelin) had demonstrated performance supportive of achieving FDA registration and that we intended to pursue registration. On May 1, 2017, we announced that the ZoptEC pivotal Phase 3 clinical study of Zoptrex™ (zoptarelin doxorubicin) in women with locally advanced, recurrent or metastatic endometrial cancer did not achieve its primary endpoint..........................Based on this outcome, we do not anticipate conducting clinical trials of Zoptrex™
In or prior to June 2017 the Defendants conspired to devise a secret plan known as "Project Rescue" that outlined a path for Mr. Dodd and Mr. Theodore to acquire the U.S. rights to MacrilenTM from Aeterna either through a Corporation named RiversEdge BioVentures, LLC, which is wholly-owned by Mr. Dodd, or another newly incorporated Corporation. In or about July 2017, while they were still employed by Aeterna, the Defendants began to develop a second secret plan, which they called "Project Rescue – Version 2". Under the second plan, the Defendants engaged the assistance of an activist shareholder named Graeme Roustan to mount a proxy contest for control of the board of directors of the Company (the “Board”). Mr. Roustan controls a currently undisclosed holding of Aeterna shares. In late July 2017, we terminated for cause the employment of Mr. David A. Dodd, the former President and Chief Executive Officer of the Company and the employment of Mr. Philip A. Theodore @clint M.E. hatte Dodd kein interesse an der Auswertung von Zopt. Die Phase3 gescheitert, somit auch der Erfolg auf Zulassung in dieser Indikation! Weitere Studien müssen durchgeführt werden um Zopt zum Erfolg zu bringen. Daher ist Zopt so schnell in die Schublade gewandert. Es ging ihm dann nur noch um Mac! Nachdem Dodd abgesetzt wurde ist auch gleich das Strategic Review Committee gebildet worden. Wenn die meinen es ist besser für die Aktionäre erst Mac zu vermarkten und die Warrants auslaufen zu lassen ................Bis jetzt gibt es im Netz keine detaillierte Studienergebnisse. On July 20, 2017, the Company announced that the Board had established a special committee of independent directors (the "Strategic Review Committee") to develop, consider, investigate and exercise oversight relating to potential strategic alternatives to maximize potential future growth and stakeholder value of the Company, including continuing to execute on our existing business plan and/or considering and recommending changes to our management and governance. On August 8, 2017, we announced that the Strategic Review Committee engaged a consulting firm and a financial advisor to assist in its efforts. The Strategic Review Committee retained Stifel, Nicolaus & Company as advisor in part to validate the commercial potential of Macrilen™(macimorelin) to assist it in determining the best means of maximizing value, which included evaluating and recommending modes of distribution including entering into partnerships or building an internal sales force, raising capital including through an investment from a strategic partner, or selling some or all of the Company and its assets. On December 20, 2017, we received FDA approval for Macrilen™ On January 16, 2018, through AEZS Germany, the Company entered into the Strongbridge License Agreement. In January 2018, in accordance with the written mandate of the Strategic Review Committee, the members of the Strategic Review Committee determined that the responsibilities of the Strategic Review Committee had been performed and were at an end and the Strategic Review Committee was dissolved effective as of January 22, 2018. https://www.businesswire.com/news/home/...ces-Legal-Action-David-Dodd http://app.quotemedia.com/data/...+15%28d%29&dateFiled=2018-03-28 Melden |