Take a deep breathBefore we get ahead of ourselves take a look at the competition..Avita Medical (avitamedical.com). Their activities parallet Renovacare in Germany, China and other places. They have been receiving FDA approval all along. The process is the same as Renovacare using a small patch if skin to create the stem cells. The difference is they use a modified nozzel sprayer which is not as efficient as RCAR. That is probably why they launched the patent challenge.
Avita is way ahead of Renovacare and a darling of the FDA. In fact they received a 53.9 million US contract. See the link:
https://avitamedical.com/2015/09/30/avita-medical-awarded-53-9-million-us-government-contract/
Check their website. RCAR is not alone in this field. Avita just received another FDA approval on February 12, in a long list of approvals. Everything RCAR does replicates Avita. Looking for a buyout with the much more efficient skin gun is a real possibility. In the meantime the FDA cinditions for clinical trial have to be identical to Avita, so why the delay? RCAR is being out lobbied maybe?
Avita's SP is $1.01 but they have 1.2 billion outstanding shares. Yesterday's RCAR enthusiasm is already waning, await another shot across the bow. Why is the FDA slow off the mark, because they are all in on Avita. Read their website.