well, page-15

Goggo, they aren't the only costs (the $8m you mentioned), see below from the report, there are two trials ($17m):

Commercialisation North America

Sales Timeline: 2013

• Start FDA venous ulcer trial:
320 patients, USD$8M, 18 months, 12 months for approval: 2.5 years total
• Start FDA diabetic ulcer trial:
380 patients, USD$9M, 18 months, 12 months for approval: 2.5 years total
• Application for approval to Health Canada under Mutual Recognition Agreement with EU

2014
• Progress with venous & diabetic ulcer trials

2015
• Commence sales