need to kick some goals this month

From the last announcement:

• "Commercial negotiations are proceeding well. The Company is confident that an announcement will be made during November 2011 and sales of VitroGro® to treat chronic wounds are expected to start in the UK and Europe during the 2nd quarter of calendar 2012, as planned."

27 days left ... again ...

• "EU Approval for Sale: The EU human trial of VitroGro® has been completed and the final report is expected during October 2011. The EU regulatory consultant is confident that the results already achieved (ASX:TIS Strong New Clinical Trial Data, 14 July 2011) are sufficient for EU approval for sale. On track for start of sales during the 2nd quarter 2012."

Money! Good! However, this is very short on detail - good as the product is, this stuff doesn't sell itself. What's the strategy - hope for a big pharma partener to take care of marketing and distribution? Any pre-order contracts in place yet? Or are we just expected to wait for the next quarterly and hope the numbers are good?

• "Manufacturing: VitroGro® has been produced with the larger scale manufacturing system and final packaging of ready-to-sell VitroGro® is about to start."

And CE audit signed off too. Good stuff.

• "FDA: Request for Designation result is expected by the end of October 2011. Expert regulatory consultants are confident of device classification. Recruitment for the FDA venous ulcer trial of VitroGro® is planned to start during December 2011."

Well, in hindsight, those consultants' expertise seems questionable, especially given the subsequent press release about how "protien structures are usually classified as biological products blah blah blah". Not a big worry (apparently, not going to change the structure of trials too much), but again, inept.


Anyway, the crucial step as I see it is to complete a distribution and marketing deal, or detail sales plans. For revenue to be coming in from April onwards, it is now the 11th hour. Discuss.