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Been waiting on this for over a yr. Bought some more today around .30. This really is the first HUGE step at launching this company. Once the sales roll in from this they will have the money to fast track their other products. Exciting days ahead.
Well OREXIGEN just got slammed with their CRL today. Required to do a cardio-vascular risk study. Looks like 2 yrs and a lot of cash for them to even continue. Arena back up front dealing with rat crap while the other 2 actually deal with real problems in Humans.
The best way to find a 10 bagger is to make one....
The meeting with the FDA IS NOT an "appeal panel." It is a meeting to discuss what exactly the FDA wants from Arena to answer the Conditional Response Letter. Specifically, in that letter the FDA wanted to see the results of the Bloom-DM II trial. Results were awesome, they will be discussing these in the meeting. Also, will probably be discussing who will be doing the independent review of the Rat tumor crap.
Arena has been tight lipped on the date of this meeting, saying it will only happen this month. I dunno about you, but before the holidays seems like a good time to do it. Who knows what it could be, FDA info leak good news to large fund managers, short covering, or millions of investors all of a sudden thought Arena was a good bet today. Which one do you think?
I dunno whats worse, these hedge fund bashers, or the idiots who believe them....
x2. The valv results in this study were consistent with those in the other 2 LARGE population studies designed to rule out Valvulopathy. This study proves nothing different. The placebo went from 1.9% to .5%, sooo fat people hearts on the placebo pill got better? Not likely. They probably dropped out shortly into the trial because they weren't losing weight. Still preliminary results that need to be looked at. We'll see what the fda says later this year after they review the DM results.
No problems. I'm very interested to see how this unfolds through the coming year. Hopefully we see 1, if not 3 ppl behind bars getting butt loved.
Last night you were able to view his profile and see all the friends that he had. Earlier this morning you could only see his picture and that he had a profile. That is the result of changing privacy options. Although i just searched again and couldn't find it, he might have changed his profile so no one can find it or actually ended up deleting it. Too late though, damage was done and proof of this impropriety has been recorded.
He didn't delete his page. Just changed the privacy settings. I was merely posting a link to the thread. People can draw there own inferences. I have done this often on new developments with Arena.
Yea we will know where it stands after DM....so how bout you quit posting...or end yourself? No one said it was a crime, just an interesting connection in light of things.
So a panel member Dr. Sanjay Kaul was found to have a facebook connection with hedge fund croney Matt Herper that works for forbes. What an unprofessional and questionable thing to be.
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_A/threadview?m=te&bn=1339&tid=177460&mid=177460&tof=14&frt=2#177460
Screen shot link posted towards the bottom.
Could this be an explanation and smoking gun to the supposed "leak" and 40% drop as soon as the fda documents were released. Kaul sent the info to his buddies, and then it spread like wildfire to all their buddies. IMO i believe this is a huge insider scam that will never be investigated.
Thanks for the re-posting this. Awareness is what we need!
I think a non-approvable letter is a bit far fetched. The only concern that was expressed was the uncertainty of what caused tumors in rats at extreme doses and if it has ANY relevance to humans. The trials proved it was safe and effective.
I do believe we'll get a CRL asking for either clarification on the data, or another rat study where they are asked to determine the mechanism of the tumors. Still bs if you ask me. But thats how this crap goes. We shall see friday.
Still waiting for the day LOI's turn into finished deals. Then, will I get excited.
The media is catching wind of the investors fight back against the FDA.
http://www.signonsandiego.com/news/2010/oct/09/arena-investors-fight-back-against-fda/
Good read.
Meridia pulled from market. Probably the reason for the small pop in pps today. Arena's potential competitor out of the game. The safety profile makes Lorcaserin look that much better now.
http://www.reuters.com/article/idCNN0823517320101008?rpc=44
U.S. pulls Abbott's Meridia diet drug off market
Fri Oct 8, 2010 12:16pm EDT
* Abbott to voluntarily comply with FDA request
* Drugmaker still says drug works in certain patients
* Ongoing discussions on Meridia in other countries-Abbott
* FDA to comment later on Friday
WASHINGTON, Oct 8 (Reuters) - U.S. health officials have ordered Abbott Laboratories' (ABT.N) controversial weight loss drug Meridia off the market, and the company said it would comply even though it still thinks the drug is safe.
Abbott, in a statement, said it was in discussions about the fate of Meridia in other countries and expects those talks to end in the coming days.
Meridia has been under fire over its increased risk of heart attack and strokes in certain patients. The U.S. Food and Drug Administration is expected to make an announcement on the drug later on Friday.
While its removal does little to dent Abbott's bottom line -- Abbott saw net sales of $30.8 billion last year but expected just $30 million from U.S. sales of Meridia in 2010 -- it highlights the FDA's concerns about safety issues in obesity drugs and could affect the fate of potential rivals. (Reporting by Susan Heavey; Editing by Derek Caney)
In that press release they mention "announcing results from their recently completed clinical trial". This could mean the DM trial, and if results are good, is exactly the ammo they need for the FDA approval. In addition to that, ARENA was just granted a patent on a specific technology that Lorcaserin uses. I'm sorry bashers, shorts, and other haters this drug looks too good for the FDA to dismiss them quietly into the night. Pending the announcement of this new data I just might load up some more.
Its great to hear about "negotiating" with a few F50 companies, but I wouldn't get your hopes up on anything. I'm going to wait until I see walmart commercials touting txt 46800 for weekend meat specials before I start celebrating the hopes of this investment taking off.
Do we have any feedback if these wsj ads were even effective?
Your comment doesn't even make sense. Your either on one side of the fence or the other. Arena hit the efficacy criteria, period.
You either hit guidelines or you dont. There isn't any gray area. Arena's drug hit the endpoints that the FDA set, and with a safety profile higher than competitors.
I agree with the notion of repricing for small business. Even if they only pay $30 a month thats advertising, and the .04 a min cost next year for all calls. Also, how many damn small businesses are there in this country? Yea, it will add up exponentially. IKE WAKE THE FU*K UP!! Keep your same pricing for small-large cap firms if you need to save face, but you need customers, and small business should be a market segment you should cater too to get to buy first...now get on it.
But how do you not understand the misinterpretation of "rat tumor data", the negative bias on the panel, the lack of cancer experts on the panel, the unprofessionalism of the meeting directors, the 30% short interest days before the briefing docs, and the premarket drop and news instantly before the fda documents were released to the public.
smells rotten to me, so before your quick to judge anyone why don't you respect the fact that people wanted to get to the bottom of things. Also, a large portion of these "cry baby investors" happen to be Medical Doctors waiting and wanting to prescribe their patients a safe drug.
Online petition, plus some detailed letters reviewing how the FDA panel was unprepared, ignorant, skewed data, and coerced a "no" vote through threats and bias presentation. Please sign the petition and spread the word.
http://www.petitiononline.com/passlorc/petition.html
Long, still think we have a good chance at approval, or some kind of conditional situation.
A - 0
B- 2 - Continued use with special monitoring
C- 6 - Continued use with labeling updates
D- 8 - Withdrawal
No abstains
Wednesday September 15, 2010 4:05
4:07
B - Dixon and Flack
C- Coffin, Gross, Felner, Henderson, Gregg, Segal
D- Flegal, Kaul, Hiatt, Waters, Weide, Veltri,Goldfine, Thomas
Wednesday September 15, 2010 4:07
4:09
The FDA makes the final decision. But this decision points to withdrawal with the possibility of severe restrictions.
Wednesday September 15, 2010 4:09
4:10
Panelists saying this was a tough decision and that there is a segment of the population who should clearly not receive the drug. But today was not about the broader benefits of the drug.
The wording of course is going to be concerning. However isn't that the point of these panels? The FDA wants any and all possible incidences and questions answered, so why would they release a document that is all gung ho when the point of thursday is to identify possible concerns. The shorts knew this document would bring fear and shake people out of their positions hence the pre-market drop, and the continued drop. I'm not one who is going to be easily swayed by something put out to do nothing but create a conversation on thursday. Crossing my fingers for a good vote, and i think we'll get it.
Exactly. Arena hit the FDA guidelines for efficacy AND safety. If the FDA doesn't approve this thats like saying you got a B on all my tests in my Chemistry class, but I don't like you so im going to give you an F+ with an option to retake next semester.
Games, games, and more games. Seriously don't read into any of this bullshit. If you believe in Arena and the results from their 2-yr clinical trials posted earlier amd their safety record then you should still. As far as the testing in rats, that occurred before the human trials and at a 17x dosage. Do you honestly think the FDA would approve human trials if it was shown to cause cancer? Hell even WATER can harm you if you drink more than 17x the usual daily amount. Like someone on another board mentioned, they are bringing up things to talk about merely because they need to have a discussion.
People were dumping before this even came out, weaklings. I added more this morning.
More FUD crap. Arena would have a REMS if there was a need. The drug was already tested to not have abuse potential, and it is safe at the prescribed dosages. Long n strong
Yea no joke. If this gets down to 6.5 i might sell off some other stuff to scoop up another few hundred shares. When the briefing docs are released tomorrow they will probably try n slash another 2-5% off with crap articles. Longs will prevail on this one.
Well thursday is the biggest day yet for Arena...
meant to put hmmmm, sorry i was runnin 3 hrs of sleep this morning. The lady kept me up all night.
We do have 2 yrs worth of data available with the largest # of people participating. Arena really went balls to the wall to make sure there would be nothing the FDA could say to disapprove them. That is more than Vivus or Orexigen can say. I believe we are well prepared for next thursday. Lets do this!!
MMM, well true they may want to see the results, however ARENA submitted all information for review as an obesity drug. The FDA set up the approval date for approval as an obesity drug. They hit the endpoints they needed. The results of this trial would just be a label modification to increase the scope of patients. We'll see though.
Oh and the DM means diabetes mellitus type II if you didn't know
It is ongoing right now, has been for this year. Jack Lief estimated that the trial should be finished by the time they go up for approval around Oct 22nd, but the data probably won't be put together until november. If approved this is another barrel of gasoline to throw on this and send the pps soaring.
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Additional Information
The kicker is going to be the results from the BLOSSOM-DM trial, if they're positive. Cmon Arena!!
Yep, nothing wrong with profit taking. I plan on holding. Im only 26, and have plenty trading/working yrs left ahead of me so i can afford this risk. But, if this gets a good vote and approval its my lotto ticket to being in the top 10% of wealth for my age. (According to an msn article i read a week ago) Crossing my fingers!!!!!!!