TIS 0.00% 0.0¢ tissue therapies limited

the news is solid.

  1. 793 Posts.
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    TIS announcement highlights.

    1) Commercial deal - discussions well advanced, announcement planned during November 2011.

    2) Clinical trial required for EU approval is now complete. Results and final report to be provided to TIS during October 2011.

    3) EU regulatory consultant is confident that the human trial data already announced is sufficient for approval for sale.

    4) Preparation for reimbursement approvals in the UK and European countries are also well advanced.

    5) Manufacturing of Vitrogro to the desired larger scale has been successfully completed to the GMP standard required for human use.

    6) Consultants (former directors of the FDA) are confident that the FRD (Request for designation) will result in a successful device classification.

    7) Preparations for the FDA clinical trial of Vitrogro for the treatment of Venous Ulcers are also complete. The Chief Clinical Investigator and the Clinical Research organisation have been appointed, the protocol has been finalised, site selection is under way and patient recruitment is planned to start during December 2011.

    8)As part of their preparation for sales in Europe, TIS Chief Scientist and Dr. Mercer met with more than twenty key wound care opinion leaders in the UK and Europe. They were unanimous in their praise and are all impatient to start using Vitrogro to treat their patients.

    9) CEO is confident of a strong market reception of Vitrogro.

    Good news all around I would think, very positive and congratulations go our to Dr. Mercer and the team for what has obviously been a lot of hard work.

    Surfrat.
 
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