As always, getting better drugs or devices to sick people quickly is a low priority with the FDA. Yes, Rytary is a better drug and while you say you would make it at the Hayward plant, we aren't going to approve in case you make it at the Hayward plant.
I bought shares in IPXL due to their financials and Rytary was just a plus. Even without Rytary, this is a very solid company and stock but this FDA decision is a little frustrating.
Not sure what the FDA is trying to accomplish here.
The FDA, conflicting with their mandate, is considering cost as part of the approval process. The FDA is not supposed to consider cost, just patient results, but the medicine that saves money is more likely to obtain approval.