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Aprilov

03/17/17 12:04 PM

#27122 RE: Bryce Harper #27121

The formulation in Canada was identical to European Approval , Abbott wanted a longer shelf life ... Your incorrect !!!

Aprilov

03/17/17 12:09 PM

#27123 RE: Bryce Harper #27121

Eicoman can verify this !!!! Old news and simple DD my friend !!!

OldtimeramI

03/17/17 1:02 PM

#27129 RE: Bryce Harper #27121

Bryce

The NDS was submitted to Health Canada back in 2007 / 2008 by NEXMED. Health Canada approved Vitaros in 2010 based on the information that was submitted back then in 2008. Since then, Apricus has worked on several stability studies, different delivery devices,etc. It now has much more data generated in this respect, to deliver a more comprehensive package to the FDA when they resubmit the NDA in the 3Q.

Good luck

sci101

03/17/17 1:03 PM

#27130 RE: Bryce Harper #27121

The formulation is the same (in fact it has since been slightly improved).
The problem was that, at the time, Apricus had a clear path and timeline on delivering the RTD, the cold chain device was supposed to just "warm up" and test the market. When it became clear the RTD would not materialise anywhere near the timeframe they initially suggested, people got pissed off.
Sadly, I was not one of them, or at least not as much as I should have been.