Closer Look: Recent developments at Delcath |
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By Patrick Crutcher |
Tuesday, 04 January 2011 11:28 |
![]() Before touching upon some analyst commentary, we want to highlight some keypoints about recent developments at Delcath. First, this NDA was submitted as a 505(b)(2) filing, since they are referencing Synerx ANDA for use with their ChemoSaturation system, which is an already FDA approved source of melphalan for the U.S. market. Typically, this approval route has less regulatory risk, since they are improving upon an already approved drug by using it in conjunction with their system. Second, they have added some experience in terms of sales and marketing by hiring Bernard Tyrell to be the Senior VP of North American Sales and Marketing. He has significant experiece in commercialization efforts for oncology products. We are also very optimistic for 2 approvals in the US and EU in 2011, based on the survival data presented at ASCO 2010. Additionally, a 6-month priority review seems likely because of the very promising data and the Fast-Track designation from the FDA. We should be hearing back about this sometime in late 1Q 2011. In a recent report from Wedbush & Morgan analyst, Gregory R. Wade, Ph.D, they maintained their ‘Outperform’ rating with a $21.00 price target. They also had the following to say about the recent NDA submission,“The Company has requested priority review of their NDA which could facilitate a 6 month review of the application and Q2:11 PDUFA date. Announcement about priority or regular review and PDUFA date from the FDA is expected within 60 days. We remain confident that the PHP system will receive FDA approval based upon the highly statistical and compelling achievement of success at the endpoint pre-specified in the Special Protocol Agreement. We will continue to follow Delcath closely over the coming months.
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