TIS 30 October 2012 SX Announcement following MHRA Rule 13...

TIS 30 October 2012 SX Announcement following MHRA Rule 13 Classification and need for EMA approval.

“The EMA submission is already substantially complete. Preparation work on this has been ongoing since early August, in case the EMA review was required.
The required format of the EMA dossier is an international standard called the Common Technical Document (CTD). This format is well understood by the Company. This was the template for the submission to Health Canada to gain approval for the first clinical trial of VitroGro® ECM and is the same format that will be required for FDA approval for sale."

TIS 18 March 2013 ASX Announcement following EMA informal rejection by the EMA.

“Following receipt of the 13 March 2013 email from BSI, Tissue Therapies arranged an independent expert review of the submission by BSI to the EMA. This assessment indicates that the submission to the EMA was poorly constructed and did not provide adequate information for the Medical Devices Group.”

Question 1 - The 30 Oct 2012 ASX announcement clearly stated that TIS was preparing the EMA submission. The 18 March this year announcement clearly says BSI prepared it. Which of the two announcement is the correct one?

Question 2 - Since it was such poor quality, we can only assume that TIS management did not see the EMA submission before it was sent by BSI. Was this because, when asked, BSI refused to provide TIS with a final draft for checking, or was it because TIS management didn't bother asking for a copy of the submission for sign off before it was sent to EMA?? In short, why didn't TIS insist on getting a copy of the submission for sign off before BSI sent it to the EMA?

Question 3 - Who, specifically, at TIS is responsible for the content of regulatory submissions made by TIS, or on behalf of TIS?

It is unlikely that any one person will be allowed 3 questions. Maybe the above Qs can be spread around...

Thanks all and sorry I can't be there. I'm laid up and rather unwell at present.