We appear to be in the process decribed at the top of page 5 ...but exactly where we are and why it will take until the end of the year is a mystery to me. I thought I knew it but I don't. Damaj said there were questions, presumably from the member states and not the Reference Member State (The Netherlands). Did Damaj say that answers to the questions were submitted back? Are we in the three-month period allowed for answering?
If you or anyone else can figure this out, enlighten me.
I have not looked into the process as of late but I do remember reading some historical info regarding the Health Canada Submission..
Nexmed filed for Approval of Vitaros with Health Canada in October 19, 2007..! The Review and Approval process usually takes around 12 Months.. But we did not receive approval until November 2010.. 3 Years after submission..!
Usually during these back and forth talks.. Health Agencies ask for specific Data ( Questions ).. For example .. I remember Health Canada asking for Stability Data in 2010.. The company must answer the Questions ( with data from the specific studies & and if they do not have them they must perform them in order to answer )..
I too was blown away by the New Target Approval "Dates".. But it is what it is.. I do think that its better they come out and say exactly when they think the target date is, rather than keeping the Shareholders waiting with Any Day Now Excuses..!
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