Timber - it won't be approval; that is a certainty. IMO QRX...

Timber - it won't be approval; that is a certainty. IMO QRX really needs to get on top of its communications with the FDA because it very much appears linked to 26 Aug PDUFA date. The hearing on 17 July was cancelled. However, my guess is that what happens after 26 Aug hadn't been sorted out with the FDA - and this is what QRX is in the middle of trying to do now. Quite possibly they have been wrong footed. The best case (and most probable) is that (in time) they will agree a new schedule.