Delcath Systems Inc (DCTH)

[ash111]

DCTH DD: many ongoing Clinical Dec. 2016, Presentation http://delcath.com/wp-content/uploads/2016/12/DCTH_December_2016_FINAL.pdf :

Ocular Melanoma- Phase 3

Hepatocellular Carcinoma (HCC)- Phase 2

Intrahepatic Cholangiocarcinoma (ICC)- Phase 2

"As of September 30, 2016, Delcath had cash and cash equivalents of $3.7 million..As a result, Delcath believes it has sufficient capital to fund its operating activities through the end of 2017".

Will Receive more $3m by 2016 year-end per 10Q.

2M CAP, vs 3 times Cash on hand., will be holding thru 2017 for a possible IDXG or AQXP type move on good DATA (I have been on both, AQXP from under a buck(to 30) and recently IDXG since .10 to over a buck). Hard to sell when you know it worth much more than $2m. driven down on low volume on no negative news!. http://investorshub.advfn.com/boards/read_msg.aspx?message_id=115900994

FDA approval +CE Mark too. "The FDA has granted us six orphan drug designations, including three orphan designations for the use of the drug melphalan for the treatment of patients with mOM, HCC and ICC.

Delcath received new FDA approval back in 2015 for "a type of liver cancer that affects bile ducts". it seems they did some major steps forward since then( beside closed $35 Million Funding Round back in June 2016,"One of the targets is in the Phase 2 and Phase 3 study of its Melphalan/HDS").

http://poststar.com/business/local/delcath-receives-new-fda-approval/article_0d206ce0-cfe0-5fa2-97cc-d7c911d1848d.html

"In Europe, our system has been commercially available since 2012" 

2H2016:
• German ZE Reimbursement Level Defined
• P2 ICC Cohort Enrollment Completed
• EU Registry Data Readout #2

Folks are usually focusing U.S. market only but DCTH is a major P2/P3 World player for Duct Cancer and deep in EU market:
CHEMOSAT Available At Major Cancer Centers Throughout European Region:
1. CE Marked as Class IIb Medical Device with broad indication
2. >300 commercial procedures performed
3. Broad range of tumor types treated
4. Expansion into Turkey March 2016
5. National reimbursement established in Germany for 2016 after <3 years of commercial activity

recently, mentioned as a major key player for Bile Duct Cancer, among big names companies : http://finance.yahoo.com/news/world-bile-duct-cancer-cholangiocarcinoma-150500717.html