Hey 13 thumbs up must be a great post, NOT. I am a long term investor here + these posts are #$%$ + based on nothing. The DEA will post about 3 months before we hear anything from the EU so stop espousing #$%$. The thumbs up are from the pom pom queens and we all know who they are. This is a great LONG term play not a get rich quick play. Keep your heads above water + realize this is a long term play. If you want a get rich quick play go to HLF, short ot long. Mark this post as well as the original poster + see who's right. It won't rocket to 30 next week or in 12 days when the DEA posts their final classification and another 30 days till sales start. It won't hit 30 for another 2 years. You all need to get a reality check around the stock. It will be a huge long term winner + it won't be a short term success, get REAL.
I couldn't agree more, Mario. There are some mega-dingbats on this board who engage in mutual reinforcement of their own silly ideas that involve plucking a number from the air, and then multiplying it by their own aggregated IQs (which generally involves a doubling of the original number). It's a circle of jerks engaged in a circle-jerk... The subset of ARNA longs who actually bother to think have a more realistic (but obviously still positive) view of where the PPS will go in what time frame. You are clearly one such person. The best thing to do with the idiots is put them on Ignore along with the bashers.
The following is copied with permission from a post on another board:
"ARNA: I’ve been doing some more checking into the EMA process.
On March 2 ARNA announced that it had submitted its application to the EMA.
BTW, ARNA never stated that that it submitted exactly on March 2. But let’s assume March 2 was the submission date.
“The validation period between submission date and start date is thirteen EMA working days.”
See the first footnote of this: [LINK OMITTED, but on the title of the page is this: "Full application 1
st phase (120-day Assessment)"].
Thirteen working days after submission would put the start date (Day 1) of the process on March 21, 2012. ARNA issued a PR on March 26th stating only that an MAA for lorcaserin was accepted for filing by the EMA “in March”. No specific date, again.
I think many folks have assumed that Day 1 was March 26, the day of the PR. It don’t think it was. I think it was March 21.
This would mean that Day 120 occurred on July 19, and the Day 120 questions were provided to ARNA on that date, not July 24. The July 19 date is also asserted at the end of this well-written post from the IV board: [LINK OMITTED, but the title of the post is: "lorcaserin: Timetable in Europe (MAA)"]
If Day 1 was March 21, and the Day 120 questions were received by ARNA on July 19, then the deadline for ARNA’s responses would have been either October 17 or 19 (depending on whether ARNA had “90 days” or “three months”; I’ve seen both).
Assuming ARNA submitted on the deadline, and the deadline was October 19, then Day 180 will happen next week on December 18th. If ARNA submitted on October 17, Day 180 will fall on December 16. If ARNA submitted a few days early it could be today, or could have already happened this week.
ARNA will learn on Day 180 whether or not they will have to make an oral presentation. If they are required, then the clock would stop until the presentation is made. I would expect that ARNA would issue a PR if they are told on Day 180 that they will have to make an oral presentation. If we hear nothing from ARNA by the end of next week, then I will begin to believe that we are looking at a DAY 210 CHMP recommendation (the Big Deal) by January 17."
Me again: However, the launch in Europe can happen only 60 days after the recommendation of the CHMP, when we get the final decision, which will follow the CHMP recommendation (I have yet to find one example where the final decision was not in line with CHMP's recommendation. (That would be around mid-March, possibly a month later if ARNA has to submit present explanations).
And the launch in the US will happen about 105 days (+/- 10 days) after the publication of proposed
DEA scheduling rule (Right now that would be very late March if we see the proposed rule tomorrow).
So, assuming ARNA is approved in Europe and the DEA publishes the proposed scheduling rule this month, the launch in the US and the launch in Europe should happen within a few weeks of each other.
Thanks for posting the timelines; very helpful (especially for trading purposes).
I'm actually just waiting for an EU partner to be announced...to me that is the next big event coming & say, in cloaked fashion, that EU approval is very likely; it's an easy way for Arena to say "things are looking excellent for EU approval" without actually having to say it...avoids all that legal mumbo jumbo.
It may happen because it takes the DEA too long to schedule a new drug.
According to the EU Approval Process 210 days Timeline we could get the EMA Final Approval on or before (01/18/2012):
Day 001 (3/24/2012): EMA accepted ARNA application for lorcaserin.
Day 120 (7/22/2012): EMA sent ARNA a List of Questions. (ARNA has 60 days to respond)
Day 121 (9/21/2012): ARNA responded to List of Questions.
Day 180 (11/19/2012): EMA sends ARNA a List of Issues. (ARNA has 30 days to respond)
Day 181 (12/20/2012): ARNA has Oral Explanation to List of Issues.
Day 210 (01/18/2012): Final Scientific Opinion.
The other more likely scenario is that at Day 180, 11/19/2012, the report Arena receives from CHMP does not have anymore questions/issues for Arena to address. There may be some minor questions that can be taken care of without any oral explanation. In this case, the report is probably positive, indicating that Belviq will be approved. If this is the outcome, then sometime between Day 181 (11/20/12) and Day 210 (12/19/12), an official approval decision will be handed.
This means we may get the EU approval this week!!!!!
Most likely the DEA scheduling announcement will be this week say we get buy Friday Dec. 21 st. Then add the 30 Days Comments that will take us to January 21st, 2013.
In a MF blog written last Thurs., they had Arena responding around Oct.25th and has the final approval about a between 12/24/2012 and Jan 23, 2013 Not picking hairs, as in both the timing is very close either way.
It seems that if we have any un-approvable problems, we could know in the next 2 to 6 weeks (Like that other Co., LOL).
It concerns me that the EMA's1st concerns were identical to the 1st ADCOM's concerns.The FDA also required some initial testing that will be run with the launch. Does the EMA do the same thing or do they just give a yes or no?
I am heavily long in ARNA, but I just can't get that "Slam Dunk" feeling about the EMA.
I have listened to most of the recent conferences and they haven't had much to say about EMA progress.
The duration for ARNA to respond to the EMA 120 Day questions is 90 days not 60 days according to the "The Looming EU Approval Makes Arena Pharmaceuticals Significantly Undervalued" article by By Joseph Dedvukaj - December 13, 2012. Therefore ARNA responded on 10/20/2012 and Day 180 (12/19/2012): EMA sends ARNA a List of Issues. (ARNA has 30 days to respond)
Day 181 (1/18/2012): ARNA has Oral Explanation to List of Issues.
Day 210 (2/18/2012): Final Scientific Opinion.
"The other more likely scenario is that at Day 180, 12/19/2012, the report Arena receives from CHMP does not have anymore questions/issues for Arena to address. There may be some minor questions that can be taken care of without any oral explanation. In this case, the report is probably positive, indicating that Belviq will be approved. If this is the outcome, then sometime between Day 181 (12/20/12) and Day 210 (1/18/12), an official approval decision will be handed.
Based on a recent article, that is still several months away. Between all the Q/A sessions and rebuttal time frames we may not be looking for launch realistically until April/13. Between now and then DEA shouls be decided. Just buy and sell small lots to lower cost average and slowly bring down your PPS. At some point we all will be profitable. There has been many $0.50 rises and falls in the stockprice. Play the market, buy/sell and reduce your cost and at the same time you can get some right offs for this year and next.
I am hoping so! There are so many ways that a more effective process could exist (safer and brining life saving drugs and devices to market more quickly).
I would love for the EU to beat the DEA and have people ask what just happened?
Sentiment: Strong Buy