wall street journal avita to dominate, page-14

There is one event on the horizon that will make all the talk about the years of a languishing share price, losing money, slow uptake and management failures irrelevant. That event is the imminent enrolment of the last patient in the externally funded FDA burns trial, and then the lodgement of the approval application to the FDA 16 weeks after the commencement of treatment of that patient. Based on the past rate of enrolments, this event is due any time now.

The submission to the FDA can be made at the 16 week period after the last patient is enrolled and commences treatment. This should occur very early in 2014, with FDA approval within 6 months of submission. If so, this would be very early in FY15.

These events will influence medical practitioners throughout the world, not just in the USA. The market is forward looking and, from the announcement of the last enrolment, will ignore past failures based on the likely future take-up of ReCell and associated future earnings trends.