Ann: Update on US FDA De Novo Classification Request, page-208

OSA product a much easier potential approval. Not quite down and out as CE mark and TGA provide our IP with some intrinsic value. Good trial results, cough sound database, expertise. I didn't have the confidence to top up, but I haven't sold as without more information I see that as a kneejerk reaction. Sanofi deal losing a bad sign, but I think continuous asthma measurement was never really our advantage. I'm in the wait and see camp, trying to remain calm.

Edit: By the way we can't just put something on the app store with a disclaimer for consumers. That's not how medical devices work.