may be made by the end of July [21].
10/06/2013 10:29:23
Mar 13: CHMP issues a negative opinion for defibrotide, having concluded that results from the prevention study did not provide sufficiently convincing evidence of benefit & there were problems with the way the study was conducted, including problems with documentation and reporting of data [20].
22/03/2013 12:45:23
Feb 13: Following a meeting between Gentium and the EMA’s CHMP regarding the marketing authorization application, the company expects a negative opinion for defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy [19].
21/02/2013 21:49:17
Jan 13: Gentium announces that defibrotide will be discussed at the CHMP´s Feb meeting [18].
21/01/2013 08:55:05
Dec 12: Gentium announced that it has submitted responses to the second List of Outstanding Issues to the EMA [17].
19/12/2012 10:49:08
Sep 12: CHMP has decided to adopt a second List of Outstanding Issues following company oral explanations [16]
11/12/2012 15:44:55
Sep 12: Gentium announced today that it has been asked to present Oral Explanations on September 19, 2012 to the EMA CHMP"as part of the review process of the Company´s Marketing Authorization Application (MAA) [15].
12/09/2012 10:07:10
Jun 12: Gentium has submitted its response to the Day 120 list of outstanding issues & is hopeful for a positive opinion in 3Q 12 [14].
05/07/2012 16:59:27
Dec 11: Following a clarification meeting recently held with the Company´s Rapporteurs, Gentium anticipates submitting a response to the Day 120 List of Questions from the CHMP in the first quarter of 2012. [13]
30/12/2011 08:31:08
Oct 11: Company has received and reviewed the Day 120 List of Questions (LoQs) from the European Medicines Agency´s Committee for Medical Products for Human Use and anticipates that it will submit its responses by the end of December. [12]
21/10/2011 08:23:49
Aug 11: New Drug Application (NDA) for defibrotide voluntarily withdrawn following recent correspondence from the US FDA identifying numerous "Refuse to File" issues. I FDA raised concerns regarding the completeness of the datasets for both the treatment and prevention studies and requested that additional quality reviews of the original datasets and databases are conducted. The FDA also requested additional details regarding the conduct and monitoring of the trials by the independent review committee. [11]
19/08/2011 08:22:05
Jul 11: Filed in US to treat adults and children with hepatic veno-occlusive disease, who are undergoing hematopoietic stem-cell transplantation (HSCT) [10].
14/07/2011 21:38:01
June 11: EU assessment under accelerated assessment procedures effectively reducing review time by two months [9].
15/06/2011 10:11:29
May 11: Filed in the EU for treatment & prevention of hepatic veno-occlusive disease (VOD) in haematopoietic stem-cell transplantation therapy, in adults & children [8].
12/05/2011 11:28:39
Feb 11: Company plan to file for regulatory approval in EU and US by the end of 2Q 2011 [7].
10/02/2011 09:01:48
PIII in EU in adolescents and children (5)
02/04/2009 11:06:23
Orphan drug status i |
