Delcath Systems Inc (DCTH)

[ash111]

Agree. Btw. 90 taken out A.H.So many small cap bios are absolute turds that refuse to go up, until one day they aren't.when a solid uptrend starts, those who jump in at $.80-$1 will do very well.imo. the company has now $6.7m in Cash, about 3 times cap. Many ongoing ClinicalDec. 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". 

Just Received more $3m by 2016 year-end per Financing Equity, mentioned on past 10Q too.(had $3.7m+ $3m = $6.7m Cash on Hand) 

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 ;

Top-line results by the end of this year, 2016(Any-time): 

Our global Phase 2 clinical program in HCC and ICC continues to move forward. As we have discussed, the HCC portion of this study is enrolling at a slower pace than the ICC portion due to the stringent HCC inclusion criteria, the small target patient population and competition from other trials seeking to recruit similar patients. We are near completion of the 11-patient cohort of ICC patients and expect to report top-line results by the end of this year. In addition, European Investigators have undertaken a retrospective data collection for patients with ICC in Europe. These promising outcomes and observations were discussed with our KOLs at a Delcath-organized Medical Advisory Panel Meeting and led to the agreement that the CHEMOSAT treatment does, indeed, demonstrate an efficacy signal and is worthy of immediate full clinical investigation. As a consequence, we are focusing our resources on advancing the ICC indication, an area where we have strong KOL support, an established efficacy signal and a development program ready to be discussed with the FDA. 

Last October we were pleased to report that the German Institute for the Hospital Remuneration System (InEK) issued a ZE diagnostic-related group (DRG) code for CHEMOSAT. The application for nationwide coverage under the ZE scheme was made by the German Radiology Society and was widely supported by major German cancer hospitals, which speaks to the confidence the German clinical community has in CHEMOSAT. Since then we have been working with hospitals to support their negotiation for German reimbursement levels. We are pleased with our progress and with the rates we have been securing. These positive negotiations are expected to support our efforts for payment in other markets where we are leveraging this German experience, such as the Netherlands. 

We have a number of important milestones before year end and we look forward to providing ongoing updates on our clinical and commercial progress. 

Sincerely, 

Jennifer K. Simpson, Ph.D., MSN, CRNP President and Chief Executive Officer