Hi daveg.Hope you had a good weekend?Q .Why do RGS need a FDA...

Hi daveg.

Hope you had a good weekend?


Q .Why do RGS need a FDA approval for animals? (if that is what you meant)


A .The autologous procedure is seen by regulatory authorities as an act of veterinary surgery (removing fat/processing/re-injection at the veterinary practice), while the manufacture and shipping of product is seen as a manufacture of medicine (over seen by the FDA)

Q .RGS patents are locked up tight...are the other Companies you mention got a similar approach (vials) or different again..


A .Source of cells is different, and not as "good" e.g. Renovocyte uses other tissues - not fat. Fat is a great source of cells as it is readily available and has ~500-100x more cells than e.g. Bone Marrow (the traditional source of cells)


Q .And are they also going the human line..


A .My understanding is that the competition is not going of the human side. However you should look to e.g. Osiris (human side, but not osteoarthritis)

Q .Finally do you need FDA approval for humans if the source and recipient are the same?

A .Yes, RGS will need FDA approval, however RGS will understand both the process in detail (as well as the FDA will know RGS), and have a good source or "pre-clinical" data.