selling exhausted, page-42

You ask good questions Onshow – but really how would anyone know (holder or not). You can actually be a supporter of ISN or holder without being inside the boardroom taking notes of every decision the company makes.

But heres two guesses.

It is possible that SonoSentry is not financially viable without US OTC approval. So why bother with the Aussie market because if it fails in the US your stuffed anyway.

The second guess is that I think that FDA approval of SonoSentry sets the scene for approval for the app based wheeze monitor.

Medical device approval is often sequential – this device is equivalent to that device and that device was approved so this one should be too. So if SonoSentry is approved for OTC this strengthens the case for approval for the app based version – which by definition is OTC.

If SonoSentry is not approved – then this would present major problems for approval of the app based version (which is only thing that distinguishes ISN from all the other apps out there).

If this is right there is actually quite a lot riding on the approval of SonoSentry and maybe why no-one cares about the TGA