Note: There is no difference between 180 day questions and FDA questions...they are questions needed for clarification during the review process.
My best estimate to approval. I am being a little conservative on the Arena respone, using 1 month. It could be as little as 2 weeks.
Day 180 response provided Feb 18 2013
Assessment report Mar 8 2013
Oral presentation March 26 - 28
CHMP opinion April 29
EMA approval between June 29 - July 29th
I completely agree with what Kutz says a few posts down in this thread. One could drive oneself nuts trying to guess who might report what when (many of us did that a couple of weeks ago). Kutz is spot on about the outside consultants, and I would think that ARNA will take as long as they have available to craft their responses as carefully as they can. Why rush something so critical? At the moment, I have tuned Europe out of my own thinking, at least for a few months.
I think you're off alittle. Whenever Arna replies to the 180 day question the clock starts again correct? And CHMP has to give an opinion on day 210. So if they reply to the questions in Feb. CHMP will give its opinion in March. I'm not sure how often the EMA meets though.
After ARNA replies to the 180 day questions, the clock does restart. BUT, I believe the clock can stop again if there are additional questions/issues from CHMP. tiger-joseph posted some statistics that showed several EU applicants with multiple 180 day LoOIs.
Dog: I think his timeline (rising) is reasonable and possible thru the oral presentation--but who knows?
We must remember that the CHMP will have independent consulants review the data regarding the outstanding questions in addition to their review! There isn;t a person on this board (and I mean nobody) who can predict how long they will take before reporting to the CHMP. Do ya think that CHMP wants their consultant views before or after interacting with ARNA? To me the consultant thing is the rate limiting factor on timeline! its not logical for them to meet until their (EU) consultants give their two cents! Who knows if they have or not picked them yet or even forwarded reviewable data to them?
It could go fast or it could drag on and lead to different guidence from Lief down the road. Its a fluid but evolving process dependent on others. Other than speculation, its fruitless, to keep trying to pin this in to "day" timelines--it really is!
For me I use the speculation that ARNA will do their part in Feb---then CHMP and ARNA do march or april thing---then the recommendation comes and maybe get finalized before the fourth of July! but I also know other factors could speed it up or slow it down too! Until more of this works thru, my eye turns back to the US in the interim as thats likely coming quicker!
You folks are going to actually forget so much about the EU once the DEA rules and we get to the launch---you all will be obsessing on roll out numbers anyway and the EU will be some abstract thing going on in the background that might sneak up and surprise ya!
its important guys but so is the US--you are lucky you haqve potential momo from multiple sources to feul ARNA. if it was just about the EU then I would have sold with Tiger--but its not!
Sentiment: Strong Buy