There many reasons why the costs for that 6 months doubled that had nothing to do with trials etc. They have been gone through before, if you think back to all that was going on that 6 months you will remember some out of the ordinary costs, many of them that were rather expensive. As well going forward revenues with rise monthly and production will rise monthly which in turn will bring down CB and increase margins.
I mentioned in the US one thing many may not take into consideration, and I don't give it a ton of weight, but, every little bit helps. One of the major costs during that 6 months were those involved with the new production facility which Avita acquired the lease, equipment and materials from the former company as well as stock it up for ramping up sales.
The thought/consideration on the new facility was this, prior to Avita acquiring the new facility and beginning manufacture of ReCell on August 22nd Avita paid this company to produce ReCell at a profit for them, that included not only those Avita sold but also what Avita provided for the trials but also for the compassionate use program, now Avta not only saves the money from paying the other company a profit but in turn makes a profit on those kits themselves. Doesn't sound like much but is is quite a bit when you think about it.
Have a think about costs to get the US head office and all the people involved their hired, trained, the increase in the number of burn conferences to almost weekly, one week they were at two.
On the trials for the juveniles I agree they officially end December 2019 but I would offer that they have given their abstracts from juveniles at the recent ABA conference..
The final trials for Adult use last year officially ended in December 2018 and the previous April the abstracts were for adults at the ABA conference.
https://www.smartpatients.com/trials/NCT03333941
In this adult trial there were juveniles in it but only 5-6 and these numbers were deemed to small for approval, at the recent ABA the number 1 abstract was the one foe juveniles and included summary results from 23 other juvenile patients.
I believe as these trials are an ongoing study by the very nature of the wounds occurring (can't round up 60 kids burned at the same time same in 100 adults) at various times, the end of the trial is not as relevant as in other cases as well the trials I believe are done in 4-5 weeks on each patient with follow up checks lasting up to 5 more months. And that they are considered two be done really in two phases so a trial every 6 months in way, becuase you cannot find 60 burned kids in one fell swoop near a hospital conducting trials.
We will just have to see if lightning strikes twice. There is a large push in the US by the congress to speed up and increase emergency preparedness by BARDA for juveniles. I had thought all along one of the reasons for no BARDA announcement yet, was indeed because of not having approval for juveniles yet and the need for Avita to have the business to turn 5000 units every 6 months due to shelf life. That's just my opinion and trying to figure things out. I still believe and it is my opinion only that juvenile approval will be about the same time as the adults was, late Sept/Oct.
Peace out.
(20min delay)