DCTH $0.33 UP 7% BOUNCING BACK UP.....SEPTEMBER 13 FDA DECISION OF LIVER CANCER APPROCH COULD BE POSITIVE & MAKE STOCK EXPLODE..40C/SHARE
The stock has been manipulated to an extreme lately. The company has a strong balance sheet with over 40c/share cash net.
Recent Press release:
The company is awaiting the completion of the FDA's evaluation and decision regarding our Melblez Kit NDA by the Prescription Drug User Fee Act, or PDUFA, goal date of September 13, 2013.
Subject to acceptance by the FDA of the proposed protocol, we plan to conduct a single arm open label multicenter Phase II clinical trial. Assuming positive results in agreement with the FDA, we intend to immediately proceed with a Phase III study following the Phase II. We'll plan to prepare for the Phase III study concurrently with the Phase II study. The proposed Phase II trial will use the Gen 2 filter and we'll investigate the efficacy and safety of Melblez treatment in approximately 30 patients with unresectable liver cancer, confined to the liver in the United States, Europe and Asia.
DCTH is down significantly because of the negative opinion of a cancer--technology panel regarding DCTH's technology. However, the FDA does not have to take that opinion into account for this significant unmet need. Furthermore, the panel considered only the old technilogy and not enhancements that had been implemenmted to overcome initial problems. The company feels confident that the FDA will approve DCTH's NDA application on September 13, 2013. If that happens, DCTH will fly to $2+ in a hurry.