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Post by ashiwi on May 12, 2014 21:51:49 GMT -5
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Post by 4allthemarbles on May 12, 2014 22:19:06 GMT -5
How long after approval & paternership do you think it will be before we submit for Europe? I know their process is not as long and daunting as FDA.
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Post by ashiwi on May 12, 2014 22:21:46 GMT -5
MNKD will leave the European submission to their big pharma global partner soon after FDA APPROVAL.
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Post by 4allthemarbles on May 12, 2014 23:06:36 GMT -5
I figured as much. The benefits of working with a partner. Could that be a 6 month approval process or could it turn into a year plus time frame?
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Post by seanismorris on May 13, 2014 0:50:53 GMT -5
There is no way to know how long EMA approval will take, after Afrezza is approved in the US. My hope would be less than 12 months. Which would mean a product launch in the EU 6 months after the US (in a best case scenario). We are (in a best case) assuming the product partner announcement occurs almost immediately after US approval. We are also assuming the partner is a global pharma company... It's possible there could be a US partner and a EU one (obviously not ideal). We are also assuming that the paperwork for the EU is ready to go, which isn't likely. The partner will need to organize the data differently for EMA, which could take a few months (because back and forth information requests). I think we can throw out the best case scenario because when has Mannkind had it easy... 12 months between the US Afrezza launch and EU launch is probably a realist expectation. So, January 2016 FYI: www.slideshare.net/gas25/us-and-eu-submission-comparative |
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