ema opinion in 2nd half 2014

Bit longer to go guys, from ann just out:


Review of Operations
The final review for CE Mark approval by the European Medicines Agency (EMA) is underway. The EMA Committee review is a defined process with a maximum duration of 210 calendar days, which does not include the time taken for Tissue Therapies to respond to any questions that may be issued by the EMA reviewers.

The EMA Committee review started in September 2013 and, as is usual for this type of review, Tissue Therapies has received a series of questions from the EMA. Responding to a number of these questions requires data from the Company’s contract manufacturers. Assembling this manufacturing data will take a few months and during this time the “clock” has stopped in accordance with regulatory procedure. A favourable EMA opinion is now expected during the second half of calendar 2014.

The FDA has informed the Company that the application for a clinical trial of VitroGro® ECM for the treatment of venous ulcers will be approved subject to the provision by Tissue Therapies Limited of only one more piece of information, that of a plan for an additional quality control test. The Company will of course provide this. The FDA has confirmed that there are no other issues preventing approval of the clinical trial. This clinical trial will proceed when funding is available.