EMA Questions

I understand the current lengthy process in answering the EMA's questions is due to the fact that, while VitroGro has been classified as a device, it has been determined to also have pharmaceutical properties. Consequently it is receiving closer scrutiny than if it was simply a device. The company is trying to ensure that they address the questions in sufficient detail to avoid follow-up questions at the 180 day point in the review. They will make an announcement when the answers have been submitted.

Although the current delay in getting the product to market is frustrating, the alternative of seeking approval of a purely pharmaceutical product would have taken far longer and would have involved expensive and lengthy clinical trials. There is still keen interest in the European market for VitroGro and the company expects keen demand once the CE Mark is approved.

No, I don't work for Tissue Therapies but do have an interest as a long term shareholder.