selling exhausted, page-19

Not sure you’ve got this quite right Onshow

The FDA hasn’t rejected the application – they have asked for more information – very typical. Should this have been announced – no because nothing has been decided and there is nothing material to the sp that has happened yet.

The situation is very different to a Complete Response Letter from the FDA in the context of NDA which is communicating a decision (a rejection on the current information) which companies do (and should) announce to the market.

The application from prescription to OTC simply raises the issue of whether the treatment or device is going to be safe and effective without medical supervision. So you go back to the original submission and look at how important that supervision was in the first place.

If I had to bet one way or other I would bet on approval.

Regards Southoz.