Ongoing clinical trials, page-22

No that is not correct. That is not what he is saying.

What he is saying is that they got a contract with BARDA to supply 8 million $ worth before they have a FDA approval.

Ie he is talking it up saying that Barda committed to a purchase contract even though it is currently not approved ( back then).Their purchase could only proceed after approval.

Just like the furphy that they are shipping the day after approval - total bull.  Unlikely any company will ship and risk FDA compliance issue , break the law , without full documentation and no doctor or hospital would use it for fear of litigation unless indemnified. .  

Sales will happen when it is priced and fully documented and Dr are trained.  This was all said by the company so why try and pump it and set early expectations as it just leads to later disappointment. Avita won't be able to achieve a premium price  and get good patient results without training Dr and staff.  Only have to look at rest of world where it is available and not used to see how easy it is for company to stuff it up for years.  Do you really want them to do the same in the USA?   Plenty of great medicines and devices have been stuffed up over the years by poor control over their use.  Avita need to bed down their approved use and show results in the real world  not under trial usage so other Dr and hospitals burn units and their accountants and advisory committees can see the benefit and use the product.  The real market identified  where there is a decent cost saving is under 3000 patients a year with larger burns but 40% are pediatric ( non approved) so that reduces number further. They will obviously have to work up to that number over time and have to train etc as obviously the burns won't necessarily happen in a area of a approved center with trained surgeon with recell in stock etc. Avita will only want to supply the best complying  burns (ABA certified)  centers initially as they will offer best results to patients and they reputation.  The trained Dr's  who participated in trials and have used it for compassionate use under exemption will have a head start as their accountants will have see the the real life examples although a very small sample.