Iago, I saw your reply to me on Reds thread about HR. I did not reply because I see no reason to bring that thread back to the top. Your response was well stated and in hind sight, I should have not said anything. I just hope for Reds sake and others, they are taking notes when HR talks about investing strategy and shorting, I know I am. As far as the EMA, I would think a rise in volume would be one sign to look for. If traders think the EMA is in April, I would think they would begin placing bets. If the EMA is in April, are we looking at the 20th time frame? Can you confirm this for me? Thanks
I have written them for explanation and what I can gather over 2-3 emails is that we are definitely at 180 days. ARNA has responded to the LoOI but we don't know if they have provided an oral response. What is not clear is whether the clock stays stopped while the EMA gets the outside scientific advice. My best guess after reading their emails is that it does stay stopped until the LoOI is completely answered and that would include the request for outside scientific opinion. If not then 210 days could be this April's mtg.
I have tried but yahoo won't let me post their email. I am waiting for another response specific to the 180 LoOI response, but they take 3-4 weeks to answer.
Sentiment: Strong Buy
We don't know for sure if Arena have provided an oral response below is Craig Audet answer to Lee Kalowski on March 4th. (part transcript)
Lee Kalowski - Crédit Suisse
And just as far as where things stand in Europe, can you say, have you gone through an oral hearing? Is that something that is going to happen down the road? Or is that something that’s already happened? And as far as the list of 180-day questions, prior to that, had you given the CHMP essentially all of the same information that you had given FDA as part of their review process?
Craig Audet - Senior Vice President, Operations and Head, Global Regulatory Affairs
We have not been to an oral explanation. We have been invited to one, though. But it is still proposed at this time. The day has not been set, and it’s not definite that that will happen or not. So we have to wait until the CHMP has done a little bit more of an assessment, and then they’ll let us know whether they want us to come and speak to them.
In terms of the 180 day, we have given the CHMP the same information that we’ve given to the FDA, so they have the same information in order to make their determination in terms of safety and efficacy.
Sentiment: Strong Buy
thats the key we dont know if arna has given their oral or even if a date has been set...They cant say one way or the other...If oral was given in march which is a good guess then we will be on this month..At least we have not been rejected like vvus was which is encourageing
not true, if you look at chmp's public assessment reports of previously submitted drug applications, there could be 2 or 3x LOI after the day 180 LOI. but my take is no news is good news. if it is bad vote, like vvus, they would have to preannounce.
Sentiment: Strong Buy
Either April 26 (yes, that is quite possible) or May 31. The big issue is this: Has Arna already made the oral presentation? I have really invested a lot of my time in figuring this one out. I have even had e-mail exchanges with the EMA to clarify issues that have caused confusion.
Do not focus on the fact that ARNA was "requested" to make an oral presentation. That is standard CHMP terminology. The sponsor always has the option of making the oral presentation or not. If ARNA had turned the request down (btw, no one does that), we probably would already have seen the CHMP opinion, because the clock would have started ticking again in early March.
I think ARNA presented in the last week of March. Hence April 26 is a possibility. If they did not present at the end of March, then they will at the end of April, which means a May 31 opinion.
very possible for april agenda...The face to face could of already happened and we would not know...Problem with this process is the experts that are looking into the app, are they done? how far along are they? Will they ask for more clarification..Arna said no date for oral had been set and maybe one wouldnt...We just dont know anything until on the agenda and when this happens we will see quite the short covering