This post is really for the mavens in EMA procedures, for their comments, but all the long term ARNA longs will understand the relevance. I ask that some of those "old-timers" keep it bumped until Tiger, Elena and a few others can weigh in. I have tried to do due diligence on the written records available from EMA, based around the one thing we know for absolute certainty: That Lorc (Belv) was discussed at the Jan 7-10 meeting of the PRAC. The PRAC is a relatively new committee that started meeting in 2012, with working meetings on 3-5 Sept, 1-3 Oct, 29-31 Oct, 26-29 Nov 2012 and 7-10 Jan 2013. The Lorc review comes under the category "Medicines in the pre-authorisation phase" and it was for "discussion and agreement of advice to CHMP". At the previous meetings of the PRAC, the following numbers of compounds were reviewed under this category:
3-5 Sept: One (ironically, for the Q components)
1-3 Oct: None
29-31 Oct: None
26-29 Nov: Thirteen
7-10 Jan: Sixteen (including Lorc).
So, only the 26-29 Nov meeting is really relevant here. It was followed by the 10-13 Dec meeting of the CHMP, the main committee to which PRAC reports. And here's the thing: Of the thirteen compounds that PRAC reviewed on 26-29 Nov, not a single one of them led to a positive or negative decision at the 10-13 Dec CHMP meeting (according to the published report from that meeting).
To me, that raises a substantial concern about whether Lorc (Belv) truly is on the agenda for this week's CHMP meeting. There just doesn't seem to be enough time between PRAC and CHMP to allow the reports to be prepared, disseminated and read for all SIXTEEN compounds that were discussed last week at the PRAC meeting.
I would really appreciate the thoughts of the savvier longs on this post, particularly Tiger and Elena. Those two, and a few other old-timers will know this is not a bashing post, it does not have an "agenda", and that I am not a "short".
IMO, Lorcassern would have been on the Dec 2012 PRAC agenda if there was a Dec meeting; but there wasn't a PRAC Dec meeting due to the holidays.
The EMA, by their law, CANNOT go past 210 days which is mid Jan 2013.
No worries here, just look at the volume and price action of the equity and the options; people in the know must be buying because the EMA approval will be decided at the Jan meeting.
Sentiment: Strong Buy
Please read the following thoroughly, especially the seventh paragraph. It was written by someone else who I have been in contact with on another private board. His thoughts are the same as mine. Copying and pasting it, with permission, saves me the trouble.
"Please read the introduction to those published timetables. The only dates in those timetables that are fixed are the meeting dates for the CHMP, CAT and PRAC. All other dates are merely indicative, and subject to adjustment for a specific application. There is not just one Phase 2 start date each month for all pending applications.
If ARNA submitted on October 12, Day 210 would have happened on Friday January 11. But we have no CHMP opinion; which ARNA would have PR’d yesterday morning.
Until people began mis-reading those published timetables, everyone was debating about whether ARNA submitted the responses on October 19 or 24/25. Joseph D published an article in SA saying October 25.
Recently, people found these published timetables, saw “October 12″ and leapt to the conclusion that ARNA must have submitted on October 12 because if they had submitted later in October the published timetables indicate that the clock restart would not happen until mid-November. One guy on the IV board all of a sudden came out of the woodwork and said that Craig Audet told him privately the date was October 12.
What horse-hockey! The date October 12 was never mentioned by anyone until the discovery of these timetables.
Regardless of the indicative non-fixed dates in those published timetables, the clock re-start happened 2 days after ARNA submitted its responses to the Day 120 questions. If ARNA submitted on October 19, the clock restarted on October 21. If on the 24th, then the 26th.
Most important: ARNA received its own timetable back in March (before the PRAC even existed). That is the timetable they are working against, not those published timetables. If ARNA submitted on October 19 (which was the deadline from my review) , then October 19 was the date very likely specified in ARNA’s timetable. And guess what? That puts Day 210 at January 18. It’s a very nice fit. Everything else is a procrustean bed.
Day 180 occurred in December, there is no way around that conclusion. If ARNA was going to receive a LoOIs, they would have received it over 2 weeks ago.
Again, read the introduction to the published timetables, carefully.
BTW, the only possible wildcard out there is if there had been a clock-stop at sometime. I discount the possibility of that heavily as ARNA would have had to PR that event. Once ARNA started talking about its EU application, back in March, and posting occasional updates, IMO they then had a duty to disclose all material non-standard events. A clock stop would have been such an event. ARNA has already had one lawsuit caused by a failure to disclose, I doubt they want another."
"One guy on the IV board all of a sudden came out of the woodwork and said that Craig Audet told him privately the date was October 12."
For what it is worth, and that is very little, someone posted a similar but not identical post on this board. It was titled "This should put it to rest" or something the like (Tiger may have marked it). In this post the term "EARLY OCTOBER" was used instead of the specific date above utilized.
Iago, what you found is the same exact argument that suave9, jair and couple more about drugs reviewed by PRAC but always discussed for recommendation for denial or approval NOT TILL THE FOLLOWING month. On the other hand, surferfest, R&G, tiger and couple more found that 210 days is a written in stone for CHMP to come up with recommendation which makes THIS WEEK TO BE THE DATE FOR DECISION. However, someone also posted that discussions in IV board lean toward feb decision. REally interesting 3 days ahead..
As far as the main body of your post, I have not gone thru every product like you did today. However, before doing my research last weekend I was under the impression that PRAC is a comity established by the EC/EMA to make sure that all drugs that are sold in the EU have a proper Risk Management Plan (RMP) before the drug is sold in the market.
As far as the second part of your post, you stated:
"here just doesn't seem to be enough time between PRAC and CHMP to allow the reports to be prepared, disseminated and read for all SIXTEEN compounds that were discussed last week at the PRAC meeting. "
If you look at the time table of Page 5, you would notice that PRAC issued the Rappour-teur’s RMP Assessment Report back in December 17, 2012 (which is the date that corresponds with the January 8 - 10 PRAC meeting) The January 10th date is the SIMPLY the ADOPTION of the RMP that has already been established and worked on for about 2 months. All PRAC has to do on January 10th is simply send the RMP to CHMP and the adopted decision and that should not be that difficult to do.
If you ask me, I still think, the PRAC's RMP can be treated independently from CHMP product approval meeting, PRAC by law SHALL send the RMP to CHMP; however, I think they can send it after the January 18th decision IF NEEDED. Especially that there are still 60 to 90 days left before the Marketing Authorization by the European Commission. Like you stated, PRAC had only few meetings so far (a 6 months old baby) as the EC is trying to put PRAC in place to monitor the products in the European Union markets AS THEY ARE BEING SOLD.
If we follow this logic, the CHMP January 14 to 17 can very well include Lorcaserin independent from the PRAC RMP adoption decision for Lorcaserin and there will be no harm done. The product can still get to the market and it will be monitored based on the adopted RMP.
I think would take us to the fact that CHMP cannot violate the mandated 210 day deadline which would put the 210 day around the end of this week. Anything beyond this week will add another 30 days for the next CHMP meeting.
This is as far as I can go with this based on my understanding.
Sentiment: Strong Buy
I agree Tiger. I think that people are making way way too much out of the PRAC business. The starting point of every procedural analysis is that there is a 210 Day limit on the evaluation period. That is carved in stone. In stone. If anyone reaches a conclusion that takes the process beyond 210 days, they have made a mistake in their analysis.
The clock may only stop for very specific reasons, and giving PRAC time to catch up is not one of them. ARNA submitted in October, Day 180 occurred in December. And there is not one shred of evidence to support any speculation that the clock stopped since ARNA submitted in October. There is a lot of uninformed speculation and hand-wringing, but no evidence. And there would be evidence if the clock had stopped; because ARNA would have had to have PR'd that event.
I am confident that Day 210 occurs in January. And, because I strongly believe that ARNA submitted on October 19 (that is exactly the deadline for the 120 Day responses), I also strongly believe that Day 210 is Friday, January 18.
Thanks Tiger, what you write is all good stuff as usual. My take on PRAC is that its responsibilities involve creating (or not, if appropriate) something similar to the FDA's REMS program. There may not be exact equivalence, but maybe a similarity? Clearly PRAC reports to CHMP, but you are right that is not clearly codified when it must do that, or IF it must do that BEFORE the CHMP makes its decision, or after. It's just not clear, and I read over the same documents you and Elena must have stared at. If the PRAC report on Lorc is basically "all OK", that could move along pretty quickly, I guess... But it did concern me that none of the compounds PRAC has previously reviewed were on the agenda for the next CHMP meeting. Before I looked, I figured that some might be, some not, depending on whether there were issues or not. In the end, though, all this parsing of the EMA documents by the likes of all of us here can only go so far, and I guess we have all gone as far as we can. We will find out on Friday! Good luck to you!
Iago - I am growing tired of your soft bashing. Your not short, just stupid. Please stop. It is on the agenda and we will get a positive recommendation this week. Stop your second guessing and just wonder on your own. The rest of us know!
Well, bkinvestor, if you are the type of person who makes decisions without checking into, caring about or understanding the facts, you will probably end up losing a lot of money. Maybe not tomorrow, maybe not next week, but some day, you certainly will. And you will deserve to. When you say it "is on the agenda", that's not a fact, it's an opinion. And when you say you "know", you are in fact holding an opinion. Perhaps you will be right, and perhaps not. I would like to wish you good luck, but you don't deserve it. You make your own luck, nobody hands it to you. Remember the old phrase "the harder I work the luckier I get", and it seems to me that you are simply a lazy follower of the current trend. Also, you are now on Ignore.
If a compound is listed on PRAC's agenda, it doesn't guarantee that it will be discussed. PRAC will discuss a compound if the schedule requires them to do so.
The bottom line is that Lorcaserin was on the PRAC's agenda last week. I don't know it it was discussed or not, actually nobody does since no document was published. But it we shot up to $10.10 on a 10% (or 90 cents) jump on last Thursday on a 32 million share volume. This is a strong indicator that PRAC discussed and recommended Lorcaserin to CHMP. America (or the entire world) don't just wake up on that day and decided to buy ARNA. After that, ARNA has continued to trend up to 10.81 today with strong volumes.
In summary, I'd say that EMA approval is within this week.
Clearly I am not Elena or Tiger, but I'm feeling saucy today, so I will give my 2 cents worth.
Elena has won my heart as no matter how many people throw questioning remarks at her, she has been resolute that this is in fact, The Big EMA Week.
Tiger badly wants it to be this week, had decided it was this week, but in my humble opinion, he is still knocking it around in his own mind.
But here is my promise...
I'll tell you on Friday.
I feel the same way, donco509. I greatly respect the work Elena and Tiger have put in on the EMA process. It's horribly complex and has people here and on the IV board scrambling to put it all together. I hope my own analysis helps. But, like you say, we'll know on Friday, and not before.