BINGO !, page-11

OK, so it seems we’ve both been in for the long haul and believe me I feel your frustration, especially given the (lost) potential.

FYI and to hopefully cheer you up a little here is an extract from the AVH announcement on 28 Jan 2015:

The FDA approved study is designed to confirm the safety and effectiveness of ReCell in patients
requiring skin grafts due to burn injuries. In total, thirty subjects will be recruited into the trial so that complete follow up data from 25 subjects can be evaluated after accounting for some attrition.

Co-primary effectiveness endpoints will compare (1) donor site to treatment area expansion ratios and (2) incidence of complete closure eight assessed 8 weeks after treatment by personnel blinded to the treatment received. It is hypothesized that the use of ReCell will show a comparable (non-inferior) incidence of complete closure but with a superior expansion of donor skin. Also, it is important to note that donor site pain associated with burn surgery is a chief concern of burn patients.

Secondary endpoints will be evaluated after 24 weeks, and are hypothesized to demonstrate subject preference for the outcome of ReCell treatment vs. control, as well as superiority of the subjects’ and blinded assessor rating of scar outcomes.

This suggests it may be finished 32 weeks after enrolment is done, but who know how long it takes to enrol or do the report / submission to FDA. I do know that 25 patients is better than 100 and the parameters are much more favourable, so that has to be a positive.

Furthermore, on page 25 of the CEO address at the AGM on 22nd November 2014 they make a note that says “US burns study PMA clinical report 4Q2016”. This suggests they expect to wrap it all up by the end of next year. Now, for me that’s still a long time and we have to fund the business in the interim, but it’s not the 5-10 year line thrown out by the Dr in the article you reference. The most significant point being that they have a definitive timeline to work towards, which is the first in a long while.

I’d also encourage you to consider the management and board changes and why they took place. Is it reasonable to expect they will all deliver the same outcomes? Is it fair to assign previous failures to current management?

As I said, we’ve both been in it for a long, long time so I feel you’re pain. Just giving you an alternative perspective to consider on the forward looking position but appreciate everyone has their own opinion. All the best.