Ann: Response Lodged to EMA 180 Day Review Questions, page-20

TIS had this to say in their ASX spotlight preso.
"One 12 month pivotal trial for FDA approval for sale for treatment of venous ulcers Application submission to FDA approved subject to submission of a plan for 1 additional QC test   -250 patients prospective, randomised, control trial with double blinding: exceptional scientific standard for wound trial -Detailed statistical analyses to calculate number of patients, delta over standard of care and statistical significance -Clinical Investigators and CRO in place -Clinical trial sites in place VitroGro® ECM protein classified as a combination device/biologic by FDA: practical commercial advantages:  -No limit on number of clinical trial sites -Reimbursement involves a single negotiation with CMS; avoids device negotiations with individual US private insurance payers"

So nothing 8f the magnitude of Piii costs - simple 510k required for "device" catagory.  Not sure where combined "device/biological" sits in FDA as they come under S503 (g)(1) - and the product "mix" has a lot to do with that.   However TIS have estimated that Sales could start within 26mts of application/trial they clearly looking at low road path & thus costs.  So the lower end of costs - wet finger $7M to who knows.  As for CR - that would be contingent on sales returns from ROW sales under CE Mark adoption to determine shortfall th be filled.  Time will tell.