Arena Pharmaceuticals, Inc. (ARNA)

[JAG626]

More from the same author Never Trust the Street

WEDNESDAY, SEPTEMBER 15, 2010

The Reasons I'm Holding Arena into the Panel
I thought I’d share a few more thoughts on why I’m an Arena bagholder so to speak after the scary briefing documents the shorts took advantage of. I posted yesterday my thoughts on each question but I wanted to share some additional comments after reading Arena’s briefing book and thinking about the questions the FDA are asking once again.
Efficacy: Did Arena meet 1 of the 2 specified guidelines set forth by the FDA for approval of a weight loss drug? YES! As it states in the FDA’s briefing document, it was by a slim margin looking at overall 5% weight loss compared to placebo weight loss. Dendreon met their end point by what .02%? Arena met it, end of story. When looking at the efficacy holistically, this is when it becomes more impressive. Over 22% of patients lost at least 10% of their body weight. That is 3X times placebo. If you have 1,000,000 patients on Lorqess, that is 220,000 patients who will lose at least 10% of their body weight! That is hugely important and will be understood by the experts on the panel. Dropouts occur mainly by those who don’t experience a lot of weight loss. If you aren’t losing weight, you stop taking it. If you have success you take it and you are likely to stay on it. Those who stay on Lorqess are about 68% likely to keep the weight off compared to 50% on placebo, a significant difference. In ‘real life’ you will see prescribers write a script for Lorqess first and then combined with Phentermine for up to 12 weeks to speed weight loss or get over humps on weight loss. Lorqess will continue to be taken for maintenance. This isn’t in any of the tests but this is a real world application that is likely to be discussed at the panel. So Lorqess is very effective, especially for a subset of the participants. You don’t know who that subset is unless you take it.
Cardiovascular Risks: Did Arena rule out Valvulopathy? They met the pre-defined endpoint given by the FDA for one-sided analysis at 95% confidence. There was an insignificant difference between Lorqess patients and BLOOM and the same in BLOSSOM. The cardiologists on the panel will be much more impressed with this and the clean echo data than anything else. The NEJM also agreed that it looks like Arena ruled it out. Therefore, I think the experts on the panel say yes, Arena did rule it out despite the statistician running a different analysis.
Cancer Risks: This has been a huge piece of concern leveraged by shorts to get the stock price down and scare people out of their shares. It scared me initially too until I researched it some more. If you believe that Monkeys are a better indicator of the cancer risk than rats, you’d have to take over a bottle of pills every day to pose a significant risk. Take a bottle of anything and you will have an increased risk! Take a carton of Artificial Sweetener in your coffee every day and you’ll probably have an even greater risk. If this was truly a concern, the FDA would have never let it go through human trials. However, given that the data was there in pre-clinicals and there were no other real serious side effects to consider, they have to at least have the experts weigh in on it. I think this the panel will be confident that Arena does not pose a serious risk in real life use of Lorqess. There was nothing that came out of 2 years of data to show a concern whatsoever.
Psychiatric or Cognitive Issues: Although there were more on Lorqess that experienced increased cognitive issues, it was still a very insignificant number. This should be a labeling issue and not a reason to not approve.
Risk vs. Benefit: Lorqess is far safer than any weight loss drug that has ever come up for approval. If you believe it ruled out valvulopathy and that patients won’t have access to or could stand taking a bottle of Lorqess every day, especially without puking it up, then it is safe. If you believe that Lorqess met at least one end point (if even by a slim margin) and that a 300% improvement in losing 10% body weight is important then efficacy isn’t an issue.
Instead of being 70% confident of approval by the panel, I’m back to 90%. All shareholders should weigh the risk vs. their own financial situation. You never know with these panels and what the FDA will do after the panel, regardless of the vote. The panel could be negative and the stock drops to $1-2. The panel could approve 14-0 and the stock rocket and then the FDA still deny 5 weeks from now. They could ask for more data which would also tank the stock price. There are all sorts of risks to consider with holding the stock into this binary event so do your own due diligence, weigh the risks and decide what you are going to do before the stock is halted tomorrow and you’re stuck! Good luck to all!!!!
Posted by KLLJ Investments at 7:03 AM 5 comments Email ThisBlogThis!Share to TwitterShare to FacebookShare to Google Buzz
TUESDAY, SEPTEMBER 14, 2010

What to think of Arena's Briefing Documents?
Wow, what a crazy volatile day today. I knew it would be volatile but this exceeded my expectations. As I posted earlier, if you were nervous about the data then probably best to sit on the sidelines for this one. It would have been great to sell at $7.00 and buy back at $4 but you just never know what will happen with these binary events and that is why I don’t day or swing trade.
So where to start with the briefing documents? The market started off by crushing ARNA immediately after the docs came out. Immediately. It took me several hours just to go through the FDA briefing documents and I have barely reviewed ARNA’s. Shorts looked at the questions posed by the agency and used the scary questions to take advantage of the stock, even before anyone could have possibly read the briefing documents. A lot of money was made today by some hedge funds. The stock gapped down right after the docs were released. Even a speed-reader couldn’t get through them that fast! Shorts and bears used it to their advantage as they usually do. So to sell or hold, that is the question.
I’m still going through my analysis but here are my thoughts so far on each question posed by the FDA.

1) Has adequate evidence been provided to establish lorcaserin's efficacy as a weight-loss drug? Are there additional studies that you would recommend pre- or post approval to further evaluate lorcaserin's efficacy?
I was hoping this question wouldn’t be in here given Lorcaserin met the FDA categorical weight loss guideline. In the FDA’s version of the briefing book, they state it did meet the efficacy requirements but barely. I think they point this out to stress the risks to be discussed vs. the benefit.

2) Has adequate evidence been provided to assess the potential risk for lorcaserin-induced valvular heart disease?
This is the biggie. From what I have reviewed so far, this appears to be a result of the analysis method conducted by the FDA. According to ARNA’s specified guidance, it was to be a one-sided analysis at a 95% confidence level, which looks to be equal as a 2-sided analysis with a 90% confidence level. Instead, the FDA used a 2-sided analysis with a 95% confidence level. This will come down to a statistical discussion and what the cardiologists on the panel have to say about the data.

3) Has adequate evidence been provided to assess the potential risk to human subjects of lorcaserin-related neoplasms in rats? These neoplasms involve breast, brain, peripheral nerve, skin and subcutis.
This one is interesting. These are based on pre-clinical studies on animals. If the FDA had any real concern, then why in the world did they let the trials proceed? There was no increased risk of neoplasms in the Lorcaserin vs. Placebo in BLOOM + BLOSSOM that came out. A female patient would need to take 14 pills a day for months to have an increased risk. The side effects from taking so many pills would make you sick and it would be very difficult to do. It is the FDA’s job to point out every single possible risk to the AdCom and this is one of those. I personally don’t see this one as an issue when you look at the real world use of Lorqess and maybe a post-marketing monitoring issue.

4) Has adequate evidence been provided to assess and characterize the potential risk for psychiatric adverse events, such as dissociative disorders and depression/suicidality?
There is not much data to support an increase of any psychiatric risk factor from what I have seen in the documents. This seems to be a post-marketing monitoring issue.

5) Has adequate evidence been provided to assess and characterize the potential risk for adverse events related to disorders of attention, memory, and other cognitive disorders?
I have the same response to this one as number 4.

6) Please vote whether the available data demonstrate that the potential benefits of lorcaserin outweigh the potential risks when used long-term in a population of overweight and obese individuals to allow marketing approval.

This is the voting question for approval and there is no way to handicap this. It will come down to the discussions during the panel and what the experts feel about the data presented to them.

Before the briefing documents, I was 90% confident in approval. After reviewing the documents, I’m still confident but maybe now 70% confident. There is just no way to know going into Thursday what each panel member will think about the data and risks. The risks look to be very, very minimal. The increased risk of breast cancer is with levels that would be difficult for someone to tolerate over a long period of time. I think this is a post-marketing monitoring issue. The ruling out of valvulopathy is a big one and ARNA followed the guidelines set by the FDA and met them. The FDA may change the game on them in the middle of the match and raise the bar. This could require additional data from BLOOM-DM or new studies. Or the Cardiologists on the panel will agree with ARNA and think this is a non-issue. There is just no way to tell until the meeting takes place and the stock is halted.

So far, the analysts who said to sell at $7 were right and the bears have control. So who will be on the right side of the trade on Friday after the panel has voted? If it is a negative vote then the stock tanks, potentially under $2. If it is positive, it could cause a massive short squeeze and buying frenzy. Who knows where it goes on a positive panel. I’ll be blogging the panel meeting live on Thursday but can’t promise I won’t be drinking while I’m doing it.
Posted by KLLJ Investments at 6:09 PM 0 comments Email ThisBlogThis!Share to TwitterShare to FacebookShare to Google Buzz
MONDAY, SEPTEMBER 13, 2010

Some Light is Finally Shed on the Status of AFREZZA Partnership
Al Mann has his ‘A’ game on. At today’s Morgan Stanley Healthcare conference, Al Mann gave attendees an overview of the opportunity with AFREZZA and the status of partnership negotiations. I’ve never heard Al sound more relaxed and confident on the prospects of AFREZZA. When asked about the status of partnership negotiations Al’s response was basically that they had more inquiries than they could handle and they had narrowed it down to 6 potential partners. The next step is to narrow it down to probably 3 and enter final negotiations. As a biotech, there is no better position to be in when negotiating a commercial agreement. MNKD has multiple Big Pharmas who all want the opportunity to market the next potential diabetes blockbuster drug and that drug has a real chance to positively affect millions of patients. Al referenced the BioVid study completed in 2009 which showed that MD’s would prescribe AFREZZA to at least 25% of their diabetic patients. Since there are over 20M diagnosed diabetics in the US that is more than 5M patients and over $5B in potential annual US revenue. Add in the rest of the world, and you can see why the interest in having the rights to a piece of this pie is so attractive to many Big Pharmas. Al shed some light onto who those partners might be by saying that it won’t be someone with a current insulin program. The Big Pharma who was in the mix last year when they almost signed a deal is still in there. If that partner puts the best deal out there, then an agreement could be inked in a couple of weeks after the decision was made. If it is one of the new guys, then it could be a couple of months. Al wouldn’t speculate on if it happens before or after PDUFA.

I still believe it will happen prior to PDUFA but no longer do I think it will be this month. November might be the earliest we’ll see a deal inked given the number of partners in the mix. The big remaining question I’d like answered at one if the conferences this week is confirmation that they have received their end of review meeting minutes back from the FDA. That is a key missing link to commence final negotiations with partners. Rest assured though, despite the FUD some analysts have put out there, Big Pharma DOES want to partner with MNKD and they will get a very attractive deal. It is also highly unlikely that there will be an Advisory Committee required by the FDA, as Al stated again today.

Al has put $925,000,000 of his own money into MNKD and they now are only months from finally receiving approval and only weeks to months from inking a commercial deal for AFREZZA. Long time share holders of MNKD can finally see some light out of what has been a dark tunnel over the last few months. Given that MNKD ran to $12 last year when a partnership was expected, it may finally start an uptrend into PDUFA on renewed expectations of approval and partnership. These investor conferences should go a long way to help reassure the street and retail shareholders that AFREZZA is the real deal and has blockbuster potential written all over it.

Tomorrow, there are two more investor conferences for MNKD, one at Baird’s Healthcare conference at 1:45PM ET and one at R&R’s Global Investor Conference at 2PM. Al will also apparently be on Jim Cramer’s Mad Money at 6PM, which should be interesting since Cramer’s not a big fan of MNKD.

Tuesday the 14th will also be the day ARNA’s Briefing Documents for the Lorqess panel get released. Shorts will try to bring it down again when those docs come out I’m sure. The big key will be what questions are asked by the agency and is there anything in there that isn’t already known to investors. Once the briefing docs have a chance to digest, then hopefully ARNA will make a little run on Wednesday as shorts cover into the 16th when the stock is halted. On Friday, ARNA will either be at $3 or it could be north of $20 if the shorts capitulate. I won’t be getting much sleep in the next few days for sure! Good Investing!
Posted by KLLJ Investments at 7:58 PM 1 comments Email ThisBlogThis!Share to TwitterShare to FacebookShare to Google Buzz
Labels: afrezza, MNKD
SUNDAY, SEPTEMBER 12, 2010

Big Week for MannKind
This is a big week for MannKind. Monday kicks off the first of 9 financial conferences that MannKind will present at over 16 days. It is also rumored that Al Mann may be on Cramer’s Mad Money on Tuesday the 14th. So why the plethora of investor conferences and potential media coverage over the coming weeks? We can’t forget that the Seaside88 / Mann Foundation stock purchase agreement is set to commence on September 22nd. In order for that first purchase to happen, the volume-weighted-average of the stock price needs to be at or above $6.50 for the 10 trading days prior to the 22nd. Well the 13th of September is the 7th trading day prior to the 22nd and we are more than 10% below the VWA trigger of $6.50. Can the media and investor blitz be enough to bring in the volume and get that price above $6.50 so the first stock purchase happens? Was the date of September 22nd just a random date chosen to start the purchse agreement??? OR, is there some important news event that will coincide this week that will cause the stock price to appreciate? We’ll have to wait to find out…but I'm looking forward to Monday. At a minimum, perhaps we'll get an update on partnership negotiations at the 1st conference.

My fellow MNKD-long’s excellent blog at afresa.blogspot.com, has some of the best medical articles on the potential benefit AFREZZA could have to diabetics through better control of Post Prandial Glucose that I’ve read. I didn’t realize this but Cardiovascular disease is 76% more prevalent with those with diabetes but it makes sense. Medical evidence is starting to support the theory that PPG may be the culprit for the significant increased risk of Cardiovascular disease. I would encourage MNKD longs to read these publications posted on his site link here . AFREZZA controls PPG better than any other available insulin. This is yet another potential driver for patients to move to AFREZZA over existing Rapid Acting Analogs and why it will replace those therapies as the new Standard of Care over the coming years.

Good luck this week Al Mann and all of MannKind! In the words of Yoda, 'May the Force Be With You!'
Posted by KLLJ Investments at 7:14 AM 2 comments Email ThisBlogThis!Share to TwitterShare to FacebookShare to Google Buzz
Labels: afrezza, MNKD, PPG
FRIDAY, SEPTEMBER 10, 2010

Excellent Poll Results Courtesy of The Street.com
Awesome, I am so excited! The Street put out an article that says in their survey, that ARNA will fail! Based on their similar poll for the VVUS panel, that tells me that ARNA will pass with flying colors! Thanks Adam! Here are their findings from their scientific Hedge fund poll: http://www.thestreet.com/_yahoo/story/10857306/1/arena-pharma-will-fail-hedge-fund-poll.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA


Now we all know that Hedge Funds are very honest and open about their investment strategies. I’m sure none of them were short VVUS going into their Advisory Committee since most of them thought it would get through with flying colors according to The Street in a story posted before their panel: http://www.thestreet.com/story/10806784/vivus-prepping-for-thursdays-fda-panel.html

They must have really lost their shirts on VVUS! Or perhaps, they may have been short going into it and a lot of retail buyers bought at the top because everyone thought it would get approved and none of them did their own diligence? I don’t know but I can only feel a little bad for Retail investors in the market who lose money buying and selling stock based on headlines and no real analysis. Shame on them. I don’t blame the hedge funds, they are just trying to make money and I don’t believe there is anything illegal at all telling someone they think ARNA will have a bad panel but then being long. Or saying the Qnexa looks to be good based on the Briefing Docs but then being short. Maybe immoral but probably not illegal. I’m not saying they were but it is food for thought.

According to Adam in his analysis leading up to the Qnexa panel: “I conducted a quick poll of 20 sources last night -- biotech hedge fund managers, buyside analysts and healthcare brokers -- asking them the same question. The result: 17 votes predicting a positive Qnexa vote, three votes believing the panel will go against the drug.”

So in Adam’s poll for the VVUS panel, an amazing 85% of them were wrong! Holy Cow – that is way worse than my Magic 8-Ball! I did follow along somewhat on Adam’s blog and I remember him saying something to the effect of he was surprised the panel was as negative as it was. I was adding my comments to the Live Webcast on the Yahoo Message Board so I didn’t follow his the whole time. I believe he also said he guesses that makes Lorcaserin have the best shot of approval. Of course now 75% of his Hedge Fund friends are saying that the panel will be negative! I just don’t know who to believe any more so I’ll have to stick to my own due diligence I guess.

I sure hope The Street’s poll results continue to trend the same way. That would mean that a positive vote is looking more and more likely. I just consulted with my Magic 8-Ball, concentrating extra hard and asked, “Are those Hedge Funds Wrong about the Lorqess Panel.” It’s response, “Without a Doubt!” Now my 8-Ball is no Biotech Hedge Fund Manager or Analyst but so far it is right more than it is wrong. It certainly won’t miss calls 85% of the time. I guess we'll see how accurate The Street.com's poll was next week on Thursday. We should all thank The Street.com where Jim Cramer is Chairman for looking out for us little guys. I think Cramer said it was a good Speculative Stock a few weeks ago. I just don't know who to beleive, The Street's poll of Hedge Funds or Cramer saying it is a good speculative play.

Just like I said in my “What the Analysts Won’t Tell You About Arena” article in Seeking Alpha, “The shorts have just a few trading days left to cover their mistake. Briefing docs come out on Sept 14th and will provide insight into what the FDA is thinking. Anything that can be construed as negative will have the hedge-funds use their friends at various ‘news’ outlets such as Motley Fool or The Street to put out negative FUD pieces to scare retail shareholders out of their holdings.”

It looks like The Street is already starting with the FUD and the Briefing Docs aren’t even out yet! I can’t wait to see what comes out next week! I’ll post an updated link to my live coverage of the panel meeting next week for Lorqess. This will be a Retail Long’s Perspective with a VERY Biased Opinion type live blog. After all, I’m not a journalist or analyst, just a guy who put a bunch of hard earned money into ARNA stock. If you want an impartial real journalist’s perspective, you can follow along on Adam’s live blog on The Street website.
Posted by KLLJ Investments at 8:38 AM 4 comments Email ThisBlogThis!Share to TwitterShare to FacebookShare to Google Buzz
Labels: ARNA, Lorqess
THURSDAY, SEPTEMBER 9, 2010

Thoughts on the upcoming Lorqess Briefing Docs
I view my blog as nothing more than a message board for me to post public thoughts just like on Yahoo or Investor Village, so take it for what it is worth. Kind of like a diary for sharing my thoughts and opinions, which helps with my own due diligence. Before you read this, keep in mind that I’m just a regular old college graduate and product of the public school system. No Ivy League credentials from this guy, no special certifications and no medical training of any kind. Wall Street analysts may have a lot more credibility than me and they give actual investment advice, for which they get paid for by their employers. I don’t give any investment advice; I just post my thoughts on a stupid blog for people to read and give them ideas for their own due diligence process. The big difference between me and an analyst though is I have my own skin in this game. Now I will say that my Magic 8-Ball I have on my desk is often more accurate than a lot of analysts but that is probably just a complete coincidence. I don’t think it has any unusual powers at all, I probably just got a good one of the shelf years ago. I don't use the old 8-Ball for investment advice though, just like I don't rely on analysts for my investing decisions.


On our before September 14th, we’ll finally get insight into what the FDA has come up with after reviewing Arena’s 3,000,000 pages of data to support approval for Lorqess for the treatment and management of weight loss. That is the equivalent of going through 1,500 back to back copies of an average size King James Bible. We’ve already received feedback on the BLOOM trial results from the prestigious New England Journal of Medicine that supports the approval of Lorqess. So why is Lorqess even on a panel if it is safe?

The FDA is compelled to call an advisory committee by a number of factors but because Lorcaserin is a novel new compound, it meets the guidelines for a panel. From FDA Draft Guidance:

“C. First-of-a-Kind, First-in-Class Medical Products
Under section 505(s) of the Federal Food, Drug, and Cosmetic Act, before approving a drug no active ingredient of which has been approved, FDA must either refer that drug to an advisory committee or provide in the action letter for the drug a summary of the reasons why FDA did not refer the drug to an advisory committee before approval.
To help FDA personnel follow this guidance, and to help improve consistency between the product centers, FDA intends to adopt a similar policy across the agency for all first-of-a-kind, first-in-class medical products for human use. Accordingly, when FDA is evaluating any first-of-a-kind, first-in-class medical product for human use, FDA should either refer the product to an advisory committee or provide in the action letter for that product a summary of the reasons why it did not refer the product to an advisory committee before approval. As set forth above, the decision whether to refer such a medical product to an advisory committee should be based on the factors set forth in section III.A.1.”

Just because Lorqess is called to an Advisory Committee does not mean the FDA has reservations about approving it. Now in Qnexa’s case, their panel was called a full 3 months before PDUFA and they were put on the panel weeks after filing the NDA (which was after Arena’s.) Many of us questioned why that was the case, and the vote of the panel confirmed our suspicions. In fact, since Qnexa was a Frankenstein drug of currently available compounds it technically didn’t have to be put on an Advisory Committee unless one of the following conditions were met in the eyes of the FDA:

(a) Is the matter at issue of such significant public interest that it would be highly beneficial to obtain the advice of an advisory committee as part of the agency’s regulatory decision-making process?
(b) Is the matter at issue so controversial that it would be highly beneficial to obtain the advice of an advisory committee as part of the agency’s regulatory decision-making process?
(c) Is there a special type of expertise that an advisory committee could provide that is needed for the agency to fully consider a matter?

Given the potential market for a new weight loss drug, the FDA put Qnexa in front of a panel. Will they still approve? I highly doubt it but you never know do you?

Here are the Questions the FDA wanted answered at Qnexa’s review:

1) Taking into account the results of the assessments made with the PHQ-9 and the Columbia Suicidality Severity Rating Scale (C-SSRS), please comment on the significance of the increased adverse event reports of depression, anxiety, and sleep disorders in subjects treated with Phentermine/Topiramate (PHEN/TPM).
2) Please comment on the potential significance of the increased adverse event reports of disorders of attention, memory, language, and other cognitive disorders in subjects treated with PHEN/TPM.
3) Please comment on the potential clinical significance of the metabolic acidosis determined by decreases in serum bicarbonate levels with PHEN/TPM treatment.
4) Please comment on the potential clinical significance of the increase in heart rate observed in PHEN/TPM treated individuals.
5) Given the doses of topiramate in PHEN/TPM, please comment on whether you believe PHEN/TPM poses a teratogenic risk to the target population for weight loss.
6) Based on the current available data, do you believe the overall benefit-risk assessment of PHEN/TPM (QNEXA) is favorable to support its approval for the treatment of obesity in individuals with a BMI =30 kg/m2 or =27 kg/m2 with weight-related co-morbidities?

So what will be in Arena’s briefing documents? Nobody knows except the FDA, panel members and the sponsor, ARNA. The public won’t know for a few more days. Ideally, there are no questions and the FDA just says, ‘Hey, we think this drug is super what do you think?’ However, given the FDA may expect that tens of millions of people could potentially take Lorqess, they will be extra careful. If you look at the questions posed by the FDA for Qnexa, every single question was around safety. Efficacy was a no-brainer, the FDA stated that all 3 doses of Qnexa met efficacy goals. Since Lorqess efficacy is similar to Qnexa mid-dose, then the FDA should say the same about Lorqess. So what safety concerns will the FDA focus on, that is the question. There were no real SAE’s stat sig over placebo. Main AE over placebo was a mild transient headache. Did the FDA run their own analysis that showed different results than Arena? Did they find some profile in the SAE’s that are of concern? Are they concerned about an increased risk of depression? We just don’t know what they will ask and it is anyone’s guess. They have to ask something though and I think the questions posed may be around what to monitor for post approval, but we just don’t know.

I read I believe on GekkoWire’s Daily Pharma Watch site before the Qnexa panel that 70% of stocks will go down by 20% when briefing docs are released because they usually have something negative in them that shorts and bears can take advantage of. We don’t know if Arena will be the exception or the rule. If the docs are good, it could experience an ITMN like run when their docs were released. When those weren’t as bad as expected, the shorts were left scrambling and caused the stock to rocket up by 60% the day the docs released. Another 60% when the AdCom gave a positive vote. Of course 2 weeks later when the FDA gave ITMN a CRL, shareholders got a major haircut. You just never know and that is why biotechs have a huge risk reward associated with them. When it works out like HGSI (Phase III results not NDA) or DNDN, life is great, when it works out like ITMN then it isn’t fun. ARNA could go down on the release of the docs or shoot up. It is anybody’s call.

I take a lot of solace in the fact that ARNA execs are holding their stock. Jack Leif has never sold a share, unlike VVUS’ Leland Wilson who dumped over $2M worth of stock in the year leading up to their Advisory Committee. Wellington & Deerfield have a lot riding on ARNA as does Eisai. Eisai must have completed extensive due diligence on the data, much more than any analyst would ever have access to and they made Arena a very fair and attractive deal after digging into that data.

Whatever the briefing docs say, it is going to be a crazy volatile week for ARNA starting on Tuesday. If you are nervous about the outcome and need to preserve capital, it might be wise to stay on the sidelines for this one. If you truly believe in the data, the Arena execs and that the experts on the panel will agree with the NEJM editorial, then hold on for a wild ride! With 30M shorts and a majority of the float in strong institutional and insider hands, someone is going to make a lot of money. Will it be the shorts or the longs? I hope it is the latter or I'll have to explain to my wife why I can't retire until I'm at least 95. As always, take this for what it is, a blog post on a website of my random thoughts. I'm out until Tuesday and hope to post some thoughts on the docs late that day or Wednesday before the panel. Good investing!
Posted by KLLJ Investments at 7:47 PM 2 comments Email ThisBlogThis!Share to TwitterShare to FacebookShare to Google Buzz
The First Amendment
"Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances."

America is the greatest country in the world, despite our challenges. The flat and recovering economy, constant discussion of a 'double dip,' healthcare reform, tax reform and on and on. However, we're still the envy of every other country and with good reason.

One of those rights we cherish most of all in our country is the right to Free Speech protected by the First Amendment of the United States. I try to make it very clear in my posts that the opinions I post are my own and nobody else’s. When I ask questions to be considered, I provide facts I've research or links to data. I write these posts because I believe in the market but I also believe the investment banks that run it, use creative methods to sway the odds in their favor. I'm not a Jim Cramer fan but he lays it all on the line here: http://www.youtube.com/watch?v=HRa0B34jMOQ
I'm just your average Joe Retail Investor. I'm not a financial advisor, fund manager (other than my own personal investments) nor am I professional analyst. I'm just a critical thinker that looks at the data available to make an informed decision.
That is why I write on this blog to encourage other Retail investors to question the reasons and motives behind Upgrades and Downgrades. To perform your own due diligence for investment decisions. It is nobody's fault but your own if you lose money in the market.

Not all analysts are bad. I'm sure many mean well and they after all are just doing their jobs. But these analysts who make recommendations are no smarter than many of us and often times don't do the analysis that they should before making recommendations. Hapoalim I’m sure has gotten many of their calls right but as I point out in my last post, they also have gotten many wrong. It is best to rely on your own diligence than the recommendation of others (including me!)

Happy Investing!
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NEVER TRUST THE STREET

You can only trust yourself in this market ruled by Hedge Funds, Investment Banks and High Frequency Trading Machines.


This blog is for entertainment purposes only. Mo Money's Ramblings of an old fashioned Retail Investor Stockpicker.


Full Disclosure: Author is Long ARNA and MNKD.

NOTICE:
None of my posts constitute investment advice. It is your own fault if you lose your money!

I AM NOT A FINANCIAL ADVISOR, I AM NOT AN INVESTMENT FIRM. I AM AN AVERAGE RETAIL INVESTOR WHO WRITES ONLY WHAT I FEEL AND EVERYTHING I SAY IS MY OPINION ONLY. PLEASE PERFORM YOUR OWN DUE DILIGENCE!

Anyone is free to read and comment on my blog. I welcome your thoughts and feedback. Both positive and negative. Happy Investing!

LINKS TO PREVIOUS ARTICLES AND BLOGS

http://seekingalpha.com/article/224059-what-analysts-won-t-tell-you-about-arena

http://seekingalpha.com/article/206605-a-giant-leap-for-mannkind

http://seekingalpha.com/instablog/523862-kllj-investments/66571-first-line-treatment-for-obesity-the-holy-grail-of-biotech

http://seekingalpha.com/article/205082-is-arenas-lorcaserin-more-valuable-than-dendreons-provenge

http://seekingalpha.com/article/219163-is-lorcaserin-the-new-miracle-drug

http://seekingalpha.com/instablog/523862-kllj-investments/86782-the-importance-of-arena-s-bloom-dm-study

IMPORTANT UPCOMING EVENTS

September 14th: Release of Lorcaserin Briefing Documents September 16th: Lorcaserin FDA Advisory Committee Meeting. 8AM - 5PM ET. Follow it here. September 30th: Expected update by Arena on the ADP916 for Narcolepsy and Cataplexy. October 22nd: PDUFA for Lorcaserin approval. December 29th: PDUFA for MNKD's AFREZZA
ARENA CHART AND NEWS