could this be the reason for delay ?, page-9

TDA, what you say makes sense, but I dont think it follows that while the company has waited for EU approvals, it could not ALSO try out easier markets to enter, especially markets where medical tourism would also act as a marketing opportunity and provide first hand evidence of the safety of the product. Moreover, it would have generated cashflows to help fund more expensive market entries...Apparently, diabetes is an epidemic in the Arab world too...