ann, page-24

mitchp

..it's been called the FDA for quite some time..

anyhoo, grabbing someone else's previous summary of events to follow/watch (slightly tweaked/updated)...


1. EU approval for sale of VitroGro ("CE Mark") - this is now imminent, where someone previously estimated circa 7 June, which appears close to the mark now (pun intended)....

2. Continued roll out of "integrated communications program" for the launch of Vitro Gro - eg "publications, scientific and clinical papers and presentations at selected conferences"

3. Announcement of FDA Venous Ulcer Trial commencement/scheduled commencement in Quarter 2 2012 extending to Quarter 2, 2013 and concurrent FDA Diabetic Foot Ulcer trial. This is now late, but for mine I just want confirmation of EU sales proceeding first, then get hot onto this issue..

4. Announcement of 2012 VitroGro sales to UK, Germany Netherlands, Austria, Switzerland and Northern Italy commencing in June 2012 - awaiting confirmation after CE mark approval..

5. Announcement of proposed trial of VitroGro in France to meet French reimbursement protocols - anticipated Q3, 2012.

6. Announcement of proposed launch of VitroGro sales to commence in France, Sweden, Denmark, Norway and Finland commencing early 2013- announcement expected circa Q4, 2012.

.. so plenty on the calendar just with the EU at the moment - the FDA can wait a little time until we get into the swing of sales in the EU - get that running well, then re-focus energires towards the US imo..

good luck