I read those posts and they were very thorough in their analysis of the information then available. What went wrong? Either the EMA process works differently than what is posted in the information on the EMA website, or ARNA's responses were not submitted "in October" as Audet had stated. I doubt the latter scenario. When the Day 180 list of outstanding issues was not issued until January 18, I personally started communicating with the EMA about certain details of the process (not ARNA-specific details) , and am still trying to clarify a few things. I am doing this because this may not be the last company I invest in with a drug application at the EMA and I really want to understand exactly, in detail, how this process really works in practice. I don't fault either Tiger or Elena for coming up with the most coherent explanation of the information then available.
It turns out there were important pieces of information that no one had access to. But no one knew this at the time.
R&G, what are your thoughts for CHMP? Are you going to hold most of your shares through, or you still playing it by ear? I'm still up in the air as far as I know, I feel confident that belviq will not be disapproved. I fear there might be another LoOI issued or maybe even a delay...I've looked at the regulations for approved drugs and I feel confident we meet the secondary w/ efficacy and safety. TIA
You know what....They did a ton of research and posted all of their data for verification. The conclusions drawn were reasonable at the time.
Hindsight is always 100% correct. When did you post any credible evidence that can be verified and debated by responsible individuals on this board. You obviously have no mind of your own, only the ability to look backwards and point the finger at some of the strongest posters on this board.
I am so tired of seeing this thread and #$%$ like you on the board. Go fugh yourself and blow yourself wile you are at it.
When you have something intelligent to say, I'll take you off ignore. for now, AMF.
Do you mean the biggest liers on the board. The pumpers that will disappear when this whole house of cards fails. Ineffective low efficiency untested expensive "novel" drug, problems with DEA scheduling, Eisai has a financial strangle hold on any profits. Those "strong posters" really screwed you arnatards.
Elena's and tigerjosef's credibility are ENTIRELY UNAFFECTED. They opined. It was based on credible and intelligent analysis of a tortured pretzel process. A skein nobody can seem to untangle - which makes me happy that Craig Audet is reputed to have some experience with getting through this.
Everyone here was free to do their own DD and come up with other alternatives. I was skeptical about an approval for today but it had nothing to do with the discussion of the analysis here and I'm very grateful for Elena's and tigerjosef's contribution here. It's their kind of intelligence and analysis that makes the place worthwhile. It still remains up to me -and everyone else who invests- to come up with their own analysis, investment strategy, game-plan and discipline.
I see that my thread offended a lot of people and a lot of people also agreed with my post. I did not write this post to pump or bash or critic. I spoke the truth. 1) no chmp , which is true 2) Elena and Tiger were wrong, which is true also. You bashers took it the wrong way, assuming it was a critic but it was just a statement that was true.
If Tiger and Elena told you to jump off a cliff would you do it? NO, so stop with the Bullcarp! If you bought and sold based on someone elses DD then you are an idiot. We are all speculators in reality hoping to make money. We have, but it's up to YOU to decide what is best for your pocket.
Now they had some great DD, and I give them lots of credit for their work, I for one will keep my shares, i've done my own DD and I like where we are going, whether it's today or next month....
1) Anyone who is always 100% right would never be posting on this board. Everyone who reads posts here knows this.
2) I am THANKFUL and appreciative of all the work and research they have done and even more grateful for their kindness and willingness to share it.
3) Anyone who has believed in Jack, ARNA and Lorcaserin over the past few years will continue to patiently wait for things to unfold. News today would be nice, but if not, that just leaves the FUN of looking forward announcements.
Disclosure: I am NOT a trader and have held my stock since before the first ADCom, haven't sold a share and am glad that I've bought on dips. My only regret is not buying more at $1.35 level.
4) THANKS to tiger, Elena and all others who post in good faith and the true spirit of this board.
This is a press release issued Nov. 6th, 2012
"Submitted its response to the European Medicines Agency's Committee for Medicinal Products for Human Use's 120-day assessment report and list of questions regarding the MAA for the marketing of BELVIQ in the European Union."
In the actual CC they stated clearly that it had been submitted prior to the CC. To meet the 90 day response time, they would have need to submitted by ~ October, 25th, 2012.
When the UK and Sweden who are the Rapporteurs and are really the two nations assigned to review and make the scientific analysis of the submitted MAA. Thus all of the back and forth is between Arena, UK and Sweden (they represent the CHMP). The key question is after they receive the response, when do they restart the virtual 210 day clock. After they receive the submitted response or do they have a slight delay to ensure they have received the complete documentation needed to start the review of the submitted response? My educated opinion is that the clock started in early November, probably close to Arena's business CC date. Thus day 180 would be around Jan. 5th if my guess is right. But if the delay to start the review of the response was longer, then maybe it happened by November 15th. There is no indication in reading the document: "How drugs are approved in Europe" that there would be that long of a delay at all.
The point is that the virtual day 210 clock is moved along. If no stoppage for additional question or oral exchange it will continue to move along. I would think assuming no stoppage that the virtual 210 day clocked will stop sometime around Feb. 5th and Arena would require a response from the CHMP/EMA. At 180 days, the UK and Sweden provide either their individual or joint recommendations to the CHMP/EMA. Remember with Vivus, France recommended not to approve and the they were the main Rapporteur. The Co-Rapporteur did recommend approval, but the CHMP went along with France. In the Arena case, UK is the main Rapporteur and Sweden is the co-Rapporteur.
Therefore calling Elena and Tiger is not justified or warranted. It only makes you imo a #$%$ on the road to becoming an imbecile who has not bit of a clue about what you are talking about.
In addition, as a longtime Arena long, I don't care if EU approval happens in Feb. or March for that matter. I just care that it happens. I am focused on the commercialization launch, for me that is the next big event. Now if only a number of idiotic poster's here didn't feel a need to comment on the FR, maybe we would have had a short review time for the comments with not that many responses needed by the DEA. I do believe they will waive the 30 day waiting period after the official recommendation is made for Schedule IV, but unfortunately because of the idiocy of a few undisciplined people, the comment review period may get dragged out.
As told long ago by Arena IR person, the less comments, the less review time.....