November 27, 2017 Aeterna Zentaris Inc. (NASDAQ and TSX: AEZS) announced that the Marketing Authorization Application (?MAA?) for the use of Macrilen? (macimorelin) for the evaluation of adult growth hormone deficiency (?AGHD?) has been accepted by the European Medicines Agency (?EMA?) for regulatory review. On March 7, 2017, the Pediatric Committee of the EMA agreed to the company?s Pediatric Investigation Plan (?PIP?) for Macrilen?, a prerequisite for filing an MAA for any new medicinal product in Europe. The EMA also agreed that the company may defer conducting the PIP until after it filed a MAA for the use of Macrilen? in AGHD. The start of the EMA review procedure for the MAA has now been confirmed by EMA as November 23, 2017. http://ir.aezsinc.com/press-release/...acrilen-macimorelin-evaluation
Das schnelle Geld wird es hier wohl nicht geben. Es sei denn sie verhökern den Laden. Jetzt mal nur Mac.: Die Kohle reicht die nächsten 12 Mon. In der Zeit sollte sich die EMA gemeldet haben. Somit sollte die nächste Lizensvereinbarung nicht lange auf sich warten lassen.
Eine MAA Zulassung wird mit einer Zeit von 12 Mon. angegeben. Eine Entscheidung nach max 210 Tagen. http://www.jpsr.pharmainfo.in/Documents/Volumes/...6/jpsr05061302.pdf Das PIP-Verfahren dauert 9 bis 10 Monaten ab Einreichung bis zur Entscheidung http://www.eupati.eu/...atric-medicine-paediatric-investigation-plan/
Und noch das Wort zum Donnerstag! :-)) The commercial success of Macrilen? (macimorelin) will depend on several factors, including, but not limited to, the receipt of approvals from the EMA and similar foreign regulatory authorities; developing appropriate distribution and marketing infrastructure and arrangements for our product; launching and growing commercial sales of the product; and acceptance of the product in the medical community, among patients and with third party payers. We are not currently conducting any clinical studies. We continue to explore various alternatives to monetize our rights to macimorelin in other countries around the globe. We also continue to seek opportunities to in-license and acquire products. Our goal is to become a growth-oriented specialty biopharmaceutical company by pursuing successful development, commercialization and licensing of a product portfolio achieving successful commercial presence and growth, while consistently delivering value to our shareholders, employees and the medical providers and patients who will benefit from our products.
http://app.quotemedia.com/data/...+15%28d%29&dateFiled=2018-03-28
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