We'll discuss this again after this year and they still won't get their approval. There are three companies I know which have approval for the OTC ANDA now. If you don't think something was rejected on the original, then you need to get wise. The company they are working with didn't seem to have problems with the Rx version since they sold quite a large number of Fluticare Rx. The West-Ward had their approval in May of 2016 for the OTC. Again, I don't see having their original OTC ANDA approval, at least not until the problems or issues surrounding issues is cleared up.
Also, what happened to FDA fast track which was to reduce the time. That's been in for almost 2 years.