I agree with sci101 and Aprilov - good point sci -not delivering on the RTD was another disaster; partner deals fell through, sales in EU never took off, the original device was terrible, production issue, many blunders.
In terms of Canada what I remember was Health Canada did not accept the version they brought to the EU which was slightly different, which would have required another prolonged NDA submission to Health Canada.
Mylan/Abbott I later found out had a clause in the agreement that said unless Apricus delivered a certain shelf life product, Abt/Myn were not obligated to launch, with the new device, same formula, cold temp 7 day excursion, those shelf life requirements have been met, and Mylan is planning to launch it in Canada finally.
so many complications , mistakes, mismanagement, bad deals, over many years, not worth even talking about at this point.
It's all about the USA , if you have followed what they have said about the FDA submission, all clinical, technical, safety and efficacy issues have been addressed, the only outstanding issue is the device, meaning Apricus needs to prove patients understand how to properly use the device, that's it, then submit the NDA. Nothing left to talk about. The USA formula and device is exactly what is shipping and being used in EU right now, 7 day, out of fridge, cold temp.
Also, I don't think they would have sold Ex-USA rights if they were not very, very confident in USA approval, even though they were desperate for the cash..
And Apri has data on 1M units utilized in the EU, and 24 countries with approval, and 13 launches coming soon, and sales in 10 countries. And 3 years form now the RTD may be selling world wide and finally, about 10 years later than it should have.
