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Re: barefootrunner post# 37051

Wednesday, 12/22/2010 6:36:22 PM

Wednesday, December 22, 2010 6:36:22 PM

Post# of 97239
ROTH CAPITAL REPORT -----> Roth Capital Maintans DCTH ..&... $16.50 Price Target
ROTH CAPITAL PARTNERS
December 22, 2010

============================================
Delcath Systems Inc. ---- DCTH - NASDAQ
Buy Rated --- $16.50 Target
============================================

Prev Close: $10.81
Price Target: $16.50
Market Cap: $463 Million

DCTH: Sends NDA Package to FDA Just in Time; Buy This morning, Delcath announced that it submitted the final modules of its
505(b)(2) NDA (New Drug Application) for its chemosaturation system (known as the PHP system in its pivotal study and branded the Delcath
Hepatic ChemoSAT Delivery System in the EU) to the FDA. This announcement comes in right on time with our expectations for a filing
before the end of the year.

* Of note, Delcath filed for priority review, which would result in a
six month review period if granted by FDA. As a result, the company
remains on track to obtain potential US FDA approval, as well as CE Mark,
around the middle of 2011.

* The FDA performs a 60-day review to determine if a NDA warrants a
thorough review and will (1) assign its review period as well as (2)
establish a PDUFA (Prescription Drug User Fee Act) date at that time.
We see these events as the next predictable catalysts for the company.

* Additionally, we continue to expect that following its NDA submission,
DCTH will likely release the top-line data from its Phase II multi-arm trial to treat
other liver cancers.

* Delcath has continued to hit its key milestones as it moves the
ChemoSAT system through its respective regulatory processes, which we view as a
positive sign for management's ability to execute. Entering 2011, much
of the company's prospects sit in the hands of the FDA, which can be much
less predictable than the filing process, but we believe the data
package assembled by Delcath offers a strong probability of success next year.

* We maintain our Buy rating on DCTH .....and..... $16.50 Price Target

"Don't worry about the world coming to an end today. It's already tomorrow in Australia"

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