Wrong, then why was Contempla not approved the first time around and ADZ was? You do realize that the original plan was to launch Cotempla first then ADZ but Neos had to do an audible and launch ADZ first when Cotempla failed to get approved.
The reason why Cotempla failed to get approved the first time was because of the individual studies Neos provided to the FDA. ADZ was approved because all Neos wanted to do was show that it is "therapeutically equivalent to ADXR" which is why the sales team can't market with any of their own studies.
Neos is going the alternate route with Cotempla. They submitted clinical studies of there own to the FDA which apparently sucked the first time around. We all know how hard it is to sell an ADHD drug with no clinical studies. Cotempla will not be approved because of the poor studies and failure to convince the FDA that it is any better than or different than Concerta, QuilliChew, and the plethora of Methylphenidates out there.
Had Neos decided to go the ADZ route and go for the 505b path, then we would be having a me-too drug war but just as hard to market as ADZ due to the lack of clinical studies. Neos NEEDS studies for Cotempla bc there is twice as many XR MPHs than XR AMPs.
Hence why Jeurgen Martens is leaving the company...he already knows the outcome of what is about to go down next week. The people that understand the politics of pharmaceuticals and the FDA are already jumping ship.
Not here to troll, just giving my honest assessment of what is about to transpire with Neos