I thought it might be instructive to look over prior TIS announcements on the CE mark.
On 28 July 2014, TIS stated:
"It was evident from the detailed analysis of EMA questions when these were received earlier in
2014 that the most definitive response from Tissue Therapies would involve the development of
additional test methods for stability and release for sale of VitroGro® ECM and that this would
take a few months of work. A detailed project plan for the development of this additional testing was reviewed and agreed in onsite meetings in Belgium with the Company’s key manufacturers, Eurogentec and Catalent
during February 2014 and this has generated the data for the Company’s response to the EMA."
Obviously, the additional tests agreed with Eurogentec and Catalent were not adequate for the EMA.
Clearly, the EMA would have rejected the application if TIS had not withdrawn its scientific opinion application.
TIS Price at posting:
11.0¢ Sentiment: Hold Disclosure: Held
