Nobody in human history filed ema maa for scenesse and epp...

Nobody in human history filed ema maa for scenesse and epp before and this is a very complex endeavour with multiple influences beyond control. Consequently it is near impossible to estimate accurately when filing will be done. The work done now is to audit and complete all elements of the dosier. Better take a few weeks more and have all boxes ticked and all known questions answered.

Same for fda nda filing anno 2009 that came months after announced but was quickly approved.
Same for italian approval 2010 that came early and unexpected.
Highly unpredictable all.

One constant factor: they walk the talk at cuv and deliver.

But I admit that our patience is constantly put to the test and the sp is still in the gutter despite the 2012 starting jump. I hope you can also see that clinuvel is developing scenesse aiming at a long term sustainable and reimbursed application. The way I see it we are looking at a decade or more of robuste income from scenesse on epp alone. Maybe not a cash cow but at least a cash rabbit. Dividends will follow soon and stay.
Ema acceptance/Rejection is still a 50/50 chance but the file will contain an enormous amount of re-assuring safety data with strong efficiency stats and convincing patient feedback. This dosier and strategy will be a benchmark for any other first in class orphan drug filing in the future.
Bravo clinuvel team!