marketing approval ?

This is from a BioSA July 2014 promotional newsletter


NovoSkin Pty Ltd: NovoSkin Pty Ltd is a joint venture company with PolyNovo Biomaterials Pty Ltd, set up to develop new treatments for serious wounds and burns.

1. Clinical trials conducted by NovoSkin in Adelaide have shown that its Novosorb™ BTM product is safe and more effective than the current gold standard treatment in the repair of full thickness wounds.
2. The Therapeutic Goods Administration has now authorised specialist plastic surgeons at the Royal Adelaide Hospital to prescribe the wound implant in reconstructive surgery.
3. The authorisation is prior to full marketing approval for the treatment of wounds and burns.

www.polynovo.com/novosorb

I`m reading it as possible that marketing approval could come in Australia before the US. We have no knowledge for whatever reason as to the application to FDA for the 510k in the US.

http://www.bioinnovationsa.com.au/m...lvU0FfQTRfRmx5ZXIucGRmIl1d/BioSA A4 Flyer.pdf