Im Nachbarforum geht es schon wieder drunter und drüber ....
Und der zehnte Tag ist morgen! Also sollte morgen die Meldung kommen.
Aussagen vom 29.04. 2019 von Cosmo:
Seite 3:
"We had a pre-NDA meeting for Remimazolam with the FDA. Submission of the NDA was expected by the end of this quarter, actually I think it will be moved one week or 10 days from now, so it’s expected to be within the first half ofApril because there has been a delay in providing us with certain information that was required within the NDA package."
Seite 9:
2The Remimazolam NDA filing, as I said, is on the go. We will have to pay PAION 7.5 million as agreed in the license agreement upon filing. We're very much looking forward this filing to occur, as I said in the very next days."
Seite 10:
"Our key priorities for 2019 are the launch of Aemcolo, to file Remimazolam NDA in the U.S. to progress our product pipeline on which, as I said, we will tell more at our R&D day."
https://www.cosmopharma.com/news-and-media/...ompany-news/2019/190327
Eine Anmerkung:
Das ist am 08.05.2019 am Nachmittag! An diesem Tag ist bei Paion die Bekanntgabe der Zahlen über das 1. Quartal 2019.
https://www.paion.com/de/medien-und-investoren/...ter/finanzkalender/
Seite 11:
"Unfortunately, as I said, the non-approval of Methylene Blue was unexpected. And therefore, we immediately took measures while we were going through the dispute resolution process and these are already reflected in the expected savings that we will generate in this year which clearly assume that the organization will be completely restructured, we're not thinking anymore of listing of Aries clearly because we don't think that having Aemcolo and Remimazolam , together without Methylene Blue, make any more sense into perspective of an independent listing. So we have scrapped that plan. We're restructuring the business and going forward we expect actually to launch Aemcolo on our own, but in such a fashion that we will be able, I think to achieve substantial savings. And we will tell you more about this at the R&D day. "
Und der zehnte Tag ist morgen! Also sollte morgen die Meldung kommen.
Aussagen vom 29.04. 2019 von Cosmo:
Seite 3:
"We had a pre-NDA meeting for Remimazolam with the FDA. Submission of the NDA was expected by the end of this quarter, actually I think it will be moved one week or 10 days from now, so it’s expected to be within the first half ofApril because there has been a delay in providing us with certain information that was required within the NDA package."
Seite 9:
2The Remimazolam NDA filing, as I said, is on the go. We will have to pay PAION 7.5 million as agreed in the license agreement upon filing. We're very much looking forward this filing to occur, as I said in the very next days."
Seite 10:
"Our key priorities for 2019 are the launch of Aemcolo, to file Remimazolam NDA in the U.S. to progress our product pipeline on which, as I said, we will tell more at our R&D day."
https://www.cosmopharma.com/news-and-media/...ompany-news/2019/190327
Eine Anmerkung:
Das ist am 08.05.2019 am Nachmittag! An diesem Tag ist bei Paion die Bekanntgabe der Zahlen über das 1. Quartal 2019.
https://www.paion.com/de/medien-und-investoren/...ter/finanzkalender/
Seite 11:
"Unfortunately, as I said, the non-approval of Methylene Blue was unexpected. And therefore, we immediately took measures while we were going through the dispute resolution process and these are already reflected in the expected savings that we will generate in this year which clearly assume that the organization will be completely restructured, we're not thinking anymore of listing of Aries clearly because we don't think that having Aemcolo and Remimazolam , together without Methylene Blue, make any more sense into perspective of an independent listing. So we have scrapped that plan. We're restructuring the business and going forward we expect actually to launch Aemcolo on our own, but in such a fashion that we will be able, I think to achieve substantial savings. And we will tell you more about this at the R&D day. "