No I hadn't fogotten that Cro. I was referring to the events after that which provoked the announcement on the 4th of November (I have copied that below). It is clear that the EMA Review Committee was the one who deferred the submission until January. My point is that if that is the case then why is the new timetable on the agenda of this month's CHMP meeting for adoption if they were the ones who forced the situation in the first place.
Rev
Biomedical company, Tissue Therapies Limited (
ASX: TIS) has been advised that the EMA
Review Committee has deferred the submission of the Company’s response to the 180-day
questions until early 2015 This is the result of the EMA Review Committee’s desire to manage
its workload over the Christmas - New Year period.
Tissue Therapies was on track to meet the previously advised timetable (please see
ASX: TIS
EMA 180-Day Review Questions Received, 30 September 2014).
Based on this altered schedule from the EMA Review Committee, Tissue Therapies
management has negotiated a firm submission date for the Company to provide its response to
the Notified Body (BSI) and the commitment of BSI management to lodge the response with the
EMA Review Committee on the new acceptance date of 26 January 2015, as has been
confirmed by the EMA.
This provides certainty of dates from both BSI and the EMA for the last stage of the review of
VitroGro® ECM:
Submission of response by Tissue Therapies to BSI 19 Jan 2015
Completion of BSI review and submission of response by BSI to the EMA
Review Committee
26 Jan 2015
Review clock restart for final 30 calendar days 26 Jan 2015
EMA Review Committee assessment 26 Feb 2015
The results of an EMA Review Committee assessment are usually conveyed by the EMA to the
Notified Body within a few working days. Tissue Therapies will then be advised of the result by
BSI.
The Managing Director, Dr Steven Mercer commented, “This situation is frustrating but the
Company now would appear to have certainty as to the timing for the last stage of the review for
the approval of VitroGro® ECM for sale in the UK and Europe.”