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BCRX Last Six Months Chart Shows Downtrend Last 3 Months Sideways trend Last Month Maybe The Beginning Of An Uptrend Lets Watch This One!!!
ARNA Sideways Trend For Now. Looking For Uptrend Soon!!!
Good Entry Point!!! Uptrend Is Beginning! Anyone Following This? Are You Ready To Make Money!!!
Anyone still following this! Good Entry Point Now! She Is Moving Back Up !!! Up Trend Just Started! Charts Dont Lie! Want To Make Money! Buy During The Uptrends! Sell During The Down Trends! We Are Going To Make A Shit Load Of Money With This One !!!!
Nice start on this new run giving us shareholdres 30% by 11/02/2011. THEN IF WE GET THE EXCITING NEWS IM EXPECTING $43 PLUS IS WHAT WILL SEE BY YEAR END!!!!
Charts dont lie a little love on the ask and this one is running So Thin !!!!
CAMS SHOULD RUN LIKE THIS .0012 .0014 .0017 .0020
looking for 30% profit by 11/02/2011 this is it imo.
JPS02 vote me in !
Your Welcome ProfitChaser, appreciate you being the moderater of this board, hopefully soon we will have a lot to get excited about. If you would like Sams contact number send me your email. Im sure you have some signifcant questions for him.
Hello Hurricane Rick ,spoke with sam yesterday and he is in fact managing a couple other projects though not any relation to strat but he did say strat and its share holders will benefit from these projects and strat will be involved in these projects,though hard to put a time table on when this will happen. He did state he has invested a big amount of his own money in strat and appreciates all share holders patience. Asked about when he will put out a message to share holders he stated he will when the timing is right and has significant news to report until then it not financially feasable to do that are any PR. yes investors hub members i know most wont believe i spoke to Sam but i would state same under oath. GOOD LUCK TO ALL OF US SHARE HOLDERS WE ARE STILL ALIVE!
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!
Posted by KLLJ Investments at 1:01 PM 0 comments Email ThisBlogThis!Share to TwitterShare to FacebookShare to Google Buzz
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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
Interesting read on ARNA, a little dated but valid imo.Home » Biotech Stocks » Trading Ideas, Drug Manufacturers
Is Arena’s Lorcaserin More Valuable Than Dendreon’s Provenge?
54 comments | May 14, 2010 | about: ARNA / DNDN / JNJ
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Did I just say that out loud? What blasphemy. Or is it? The parabolic move of Dendreon’s (DNDN) share price over the last year has left everyone wondering, who is the next DNDN? It is almost cliché now to compare DNDN’s move to the potential of other biotechs. There is no doubt that Provenge is a revolutionary therapy and will be a blockbuster in its own right. For now, it is limited to late stage Prostate cancer but could still garner $2B a year in revenue whether or not insurance companies will cover it. DNDN’s market cap is already a whopping $6B. Is that fair, too low, too high? I really don’t know. What I do know is that their market cap is over $6B, right or wrong, because that is what the market has said they are worth right now. The market says Arena Pharmaceuticals (ARNA) is only worth $340M.
As I outlined in my last article, Lorcaserin is the clear favorite to be the only First Line Therapy available for the Overweight and Obese, so what is its potential value post approval? Should an Effective, Safe & Tolerable Obesity drug that becomes the defacto First Line Option for Primary Care Physicians and Internists be worth more than $6B? I think so.
The BIG (no pun intended) unknown is how large a First Line Therapy for Obesity would be. If the drug is Safe, Tolerable and Effective then it would practically be malpractice to NOT prescribe the drug as an option for patients that need to lose at least 5% of their body weight to promote positive change of health factors contributing to increased risk for cardiovascular disease or risk for becoming a Type II diabetic. As I outlined in my last article about Lorcaserin, it meets all of the criteria to become a Safe and Effective First Line Therapy for those mildly overweight to morbidly obese. What we can say for a fact is that Obesity is the largest market in the world for a safe and effective drug. Why wouldn’t a PCP prescribe Lorcaserin to an overweight patient? There is a 75% chance they lose at least 5% of their weight and a 33% chance they lose 10% of their weight. The only risk is a mild transient headache that happens in 15% of patients (9% in placebo) and is treated with aspirin until it goes away. Drop outs due to side effects were the same as placebo. Why wouldn’t a PCP try it? That is why it will become a First Line Therapy.
So what is the market for a First Line Weight Loss Therapy and what is the potential value of Lorcaserin? I can assure you that the potential partners negotiating with Arena will have their own revenue models, backed up by surveys no less, but here is mine. According to the Centers for Disease Control and Prevention, 67% of Adult Americans over 20 are Overweight or Obese. That is more than 145M potential patients that need a Safe First Line Drug for weight loss. Only 4M of those would need to be on Lorcaserin for Arena to do $4.5B+ a year in sales at full capacity (twice Provenge’s current revenue forecasts.) That is less than 3% of the Overweight population in the US.
One of the keys for the ultimate success of Lorcaserin will be for coverage by Payers. Currently only 10 states mandate coverage for Obesity therapies. Once a Safe, First Line therapy is available, I expect most Payers will cover within 12-24months after launch. Once that happens, Lorcaserin could garner a much larger market share. I estimate this should happen around 2013.
So of the 145M potential Lorcaserin patients, what percentage will go to a primary care physician and possibly receive a prescription? Let’s be conservative and say only 25% of the 145M overweight go to a doctor, which would be 36M patients. That number should be very conservative considering there are 17M Type II DM patients in the country alone. If the Arena Diabetes subset study shows positive benefit for Type II’s, then it is highly likely 17M patients would be covered for Lorcaserin by Payers. Only 4% of obesity scripts are currently written by Endocrinologists which indicates that there is an unmet need for a safe first line therapy for diabetics. So let’s use 36M potential patients as a nice conservative number with no growth factor whatsoever. And we all know that the number of overweight and obese is increasing every year.
It is important to recognize the impact of the upcoming Peer review publication for Lorcaserin BLOOM results. This publication will be followed by similar Peer reviews for the BLOSSOM study in Q4 and BLOOM-DM sometime in 2011. The Peer review is expected to highlight the excellent safety profile of Lorcaserin with impressive efficacy, which positively impacts secondary indicators such as lowering blood pressure, lowering cholesterol, improves HbA1c and lowers the risk for Type II DM. Given all of the positive health benefits of being on Lorcaserin coupled with practically no side effects, it will be a script written by PCP’s multiple times a day by the masses.
So if you believe that Lorcaserin will become a First Line Therapy, which I tried to demonstrate in my last post on the Obesity players. And, if you believe that there is a market of at least 36M Americans who visit a doctor and are overweight, then the following scenarios are realistic models of Lorcaserin value. To come up with a complete value of ARNA, you would need to add on some value for their top ranked patent portfolio, JNJ GPR119 partnership which could generate $295M in milestone payments soon along with the other compounds Arena has in trials. I’ll just focus on Lorcaserin, since that is enough.
YEAR
2011
2012
2013*
2014
2015
US Overweight Population (145M)
My Estimated Total Under Physician Care
36.0
36.0
36.0
36.0
36.0
Scenario 1: Good Lorcaserin Acceptance with 35% overall market share
Potential market penetration rate
5%
10%
25%
30%
35%
Lorcaserin sales in Billions
($1200 per patient / year)
2.16
4.32
10.8
12.96
15.12
Margin
50%
50%
50%
50%
50%
Net Income after tax (35% bracket)
0.70
1.40
3.51
4.21
4.91
Terminal Value (2015 profit/10%):
Assume perpetual 4.91 billion ,
zero growth,
10% discounting.
49
NPV (@20% discounting)
24
Net after a 50% Split with a partner
12
Total Shares Outstanding
(assumes about 20% dilution)
0.120
Intrinsic value/share at end of 2010
$100.00
Scenario 2: Average Lorcaserin Acceptance with 20% overall market share
Potential market penetration rate
2%
6%
10%
15%
20%
Lorcaserin sales in Billions
($1200 per patient / year)
0.864
2.592
4.32
6.48
8.64
Margin
50%
50%
50%
50%
50%
Net Income after tax (35% bracket)
0.2808
0.8424
1.404
2.106
2.808
Terminal Value (2015 profit/10%):
Assume perpetual 2.80 billion ,
zero growth,
10% discounting.
28
NPV (@20% discounting)
13.14
Net after a 50% Split with a partner
6.57
Total Shares Outstanding
(assumes about 20% dilution)
0.12
Intrinsic value/share at end of 2010
$54.76
Scenario 3: Poor Lorcaserin Acceptance with 10% overall market share
Potential market penetration rate
1%
3%
6%
8%
10%
Lorcaserin sales in Billions
($1200 per patient / year)
0.432
1.296
2.592
3.456
4.32
Margin
50%
50%
50%
50%
50%
Net Income after tax (35% bracket)
0.1404
0.4212
0.8424
1.1232
1.404
Terminal Value (2015 profit/10%):
Assume perpetual 1.40 billion ,
zero growth,
10% discounting.
14
NPV (@20% discounting)
6.69
Net after a 50% Split with a partner
3.35
Total Shares Outstanding
(assumes about 20% dilution)
0.12
Intrinsic value/share at end of 2010
$27.88
*A majority of states should cover Lorcaserin prescriptions by 2013.
To come up with the Expected Value of Lorcaserin, we can assign a probability to each of the scenarios. I personally think Scenario 1 is the most likely, in fact, I think it will be more widely accepted as the go to First Line Therapy for the overweight. However, we’ll assign a probability of only 25% to scenario 1, 50% to scenario 2 and 25% to the most unlikely scenario but it will give us a very conservative target.
= ($100 x .25) + ($50.76 x .50) + ($27.88 x .25)
Expected Value of $57.35 at the end of 2010 and a market cap of $6.88B, only for Lorcaserin. Keep in mind; this is only for the US. Approval in APAC and the EU will triple the size of the revenue potential of Lorcaserin.
Will it get there this year? I doubt it. I think the market wants to see approval first and then wait for some success before rewarding ARNA. However, a partnership before approval can quickly change the game. I fully expect that to happen and once it does, we’ll have insight into how Big Pharma values a First Line Obesity Treatment.
Disclosure: Long ARNA
About the author: KLLJ Investments
KLLJ is a private investment group focusing on small cap stocks in biotechnology, emerging markets and renewable energy. I have been an active investor for 15 years and focus on picking stocks with tremendous upside. I enjoy sharing my thoughts in forums such as Seeking Alpha to help with my own... More
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If the FDA Panel turns out very much in favor of Lorcaserin believe we could see $15 to $20
Stand Corrected just reread FDA Briefing Document!
2 KEY words here is DID SATISFY! Time to Load the Truck with ARNA shares under $5 we will smiling all the way to the bank Friday 09/17/2010 IMO. The advisory committee memorandum stated:
...the lorcaserin 10 mg BID dose did, by a slim margin, satisfy the categorical efficacy criterion
Review calls for new federal approach to medical countermeasures
HHS Secretary releases review and recommendations driven by pandemic flu experience
U.S. Department of Health and Human Services Secretary Kathleen Sebelius today released an examination of the federal government’s system to produce medications, vaccines, equipment and supplies needed for a health emergency, known as medical countermeasures. The Public Health Emergency Medical Countermeasure Enterprise Review: Transforming the Enterprise to Meet Long Range National Needs reviews the process and makes recommendations for a better approach.
“Our nation must have a system that is nimble and flexible enough to produce medical countermeasures quickly in the face of any attack or threat, whether it’s a threat we know about today or a new one,” Secretary Sebelius said. “By moving towards a 21st century countermeasures enterprise with a strong base of discovery, a clear regulatory pathway, and agile manufacturing, we will be able to respond faster and more effectively to public health threats.”
Secretary Sebelius requested the comprehensive review when the department encountered challenges with the 2009 H1N1 pandemic flu vaccine, highlighting the need for a modernized countermeasure production process. The review covered the steps involved in the research, development, and FDA approval of medications, vaccines, and medical equipment and supplies for a health emergency.
The review identified a need to upgrade science and regulatory capacity at the FDA. As a result, HHS will make a significant investment to provide FDA scientists with the resources to develop faster ways to analyze promising new discoveries and give innovators a clear regulatory pathway to bring their products to market.
The review also found that U.S. must more quickly develop manufacturing processes that can be used for multiple medications or vaccines rather than processes that can be used to produce only one type of countermeasure. As a result of this finding, in the coming weeks HHS expects to release a draft solicitation for one or more Centers of Innovation for Advanced Development and Manufacturing. The center(s) will focus on new manufacturing platforms that can produce a variety of countermeasures. The equipment and methods could provide a way to meet a surge in demand using facilities in the U.S. rather than relying on foreign manufacturing.
The review found that some of the most promising research and development on countermeasures is done by small, emerging biotech companies with little experience in large-scale manufacturing. Therefore, the Centers of Innovation for Advanced Development and Manufacturing will also serve as resources for young companies, helping them bring products to market and helping the U.S. government increase the number of new countermeasures available in an emergency.
The review made clear that the federal government must do a better job nurturing discoveries in their earliest stages to push them to greater maturity. Therefore, HHS will be creating new teams at the National Institutes of Health to identify promising research and facilitate its translation into vaccines, drugs, and treatments that keep Americans safe.
The review placed a special focus on the federal government’s flu response, identifying a need to upgrade flu vaccine manufacturing – from modernizing ways to test a vaccine’s strength, known as potency, to new methods to show that the vaccine is safe, as well as ways to produce the early “seed virus” for vaccines faster. Taken together, this will shave weeks of time off vaccine manufacturing. HHS will make investments in these areas as a result of the review.
The review also found that private companies have difficulty attracting investors in countermeasures where there is little or no market for these products outside of that currently needed for government stockpiles. As a result of this finding, HHS will explore ways to help small companies attract investors to develop promising countermeasures that have multi-use potential.
The HHS Assistant Secretary for Preparedness and Response led the review. All federal agencies working with medical countermeasures participated, including the Department of Homeland Security, Department of Defense, and HHS divisions of ASPR and ASPR’s Biomedical Advanced Research and Development Authority, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Food and Drug Administration. The review also incorporated input from state and local health departments, two federal advisory committees of outside experts, industry groups, venture capital experts, and the Institute of Medicine.
Read the review and its recommendations at www.hhs.gov/secretary/.
###
Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.
Last revised: August 19, 2010
HHS Home | Questions? | Contacting HHS | Accessibility | Privacy Policy | FOIA | Disclaimers | Inspector General | No FEAR Act | Viewers & Players
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Bought some more here 300 shares @ 4.91
About time someone got this S.O.B
TKOI full speed ahead! This train has left the station next stop .20 than .24 than.29 than .35 than .41 than .50 by August 16-2010 then we hear important news and 2nd qtr earnings and CC
08/16/2010 * 18:00 Q2 2010 Telkonet, Inc. Earnings Release. BELIEVE WE WILL HEAR IMPORTANT NEWS ON THIS CONFERENCE CALL
Ever wonder why no further news on "rights offering"? BELIEVE WE WILL KNOW SOON! Telkonet allows shareholders to buy more stock
By Kathleen Gallagher of the Journal Sentinel
June 1, 2010 | Telkonet Inc. will distribute warrants to existing shareholders that give them the right to buy more shares. The struggling Wauwatosa energy management technology company will hold the offering sometime this year and has not yet set a price for the warrants, according to a filing with the U.S. Securities and Exchange Commission. This so-called "rights offering" is extremely rare in the United States, said John Collopy, director of research for Brigg-Ficks Securities LLC in Milwaukee.
Telkonet said it would use any proceeds to expand sales and marketing, make potential acquisitions and pay costs associated with legal action.
The company has said in regulatory filings it is a defendant in two lawsuits. One involves a patent infringement case, and the other involves Ronald Pickett, its former chief executive, who is suing in a Maryland circuit court on claims of unpaid severance compensation, benefits and expenses.
Who will dominate this energy management market ?
Industry experts said the energy management market has tremendous potential but it’s fragmented and no companies have grown to dominate it. Such products are developed by dozens of companies, including New York-based Carrier Corp.; Maryland-based Telkonet Inc. (OTCBB: TKOI); Ohio-based Novar, a division of Honeywell International Inc. (Nasdaq: HON); and Germany-based Siemens AG (NYSE: SI).
My first guess is Novar, a division of Honeywell international or #2 Siemens AG
Could be any of these big players IMO.Friday, May 7, 2010 | Modified: Tuesday, May 11, 2010
Site Controls grows as it enhances clients’energy use monitoring
Austin Business Journal - by Christopher Calnan ABJ Staff
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Technology being developed by an Austin company to enable customers to lower energy costs is catching on as both a smart-grid and environmental product.
Site Controls LLC, an energy management company founded in 2003, developed its Site-Command device for energy management to enable clients to remotely control utilities for chain stores and chain restaurants. In addition to reducing operating costs, the product enables clients to work with utility companies to reduce power loads when it’s most critical to do so.
Site Controls LLC is capitalizing on the increased demand for energy management tools by tripling its marketing budget this year and focusing largely on full-service restaurants and non-U.S. customers, CEO Dan Sharplin said. He said revenue is projected to double this year, but he declined to talk specifics.
“We’re going to keep doing what we’ve been doing and build brand awareness,” he said.
Site Controls said it monitors more than 300,000 of its clients’ end-use devices. The company, which employs about 80 workers, doesn’t disclose its annual revenue.
Site-Command is a hardware device equipped with Site Controls’ proprietary software. The product is installed at each site to monitor sensors that measure energy usage on dozens of different end points, such as lighting, heating and air conditioning units, signs, solar panels and trash compactors. The data aggregated via the Internet at Site Controls’ headquarters, which enables the company to make adjustments according to load demand.
For example, during a power emergency, Site Controls workers can reduce the load on a power grid by cutting back on air conditioning or lighting at dozens of locations when such actions wouldn’t be noticed by workers or customers.
Industry experts said the energy management market has tremendous potential but it’s fragmented and no companies have grown to dominate it. Such products are developed by dozens of companies, including New York-based Carrier Corp.; Maryland-based Telkonet Inc. (OTCBB: TKOI); Ohio-based Novar, a division of Honeywell International Inc. (Nasdaq: HON); and Germany-based Siemens AG (NYSE: SI).
In 2006, Irving-based arts and crafts retailer Michaels Stores Inc. installed Site-Command at more than 900 stores. Last year, the company reported a more than 25 percent reduction in energy use at stores with Site-Command.
In addition to lowering energy costs, Site Controls has helped significantly reduce Michaels’ carbon emissions. By lowering electricity use by 137 million kilowatt-hours annually, Michaels reduced carbon dioxide emissions by 192 million pounds, said Rob McClay, vice president of store development and construction for Michaels.
Site Controls’ “enterprise tools help ensure we maintain and increase our savings over time,” he said.
In 2008, Site Controls bought Tulsa, Okla.-based Excel Energy Technologies Ltd. for an undisclosed amount. At the time, company officials said the deal would add other high-profile retailers to its customer base, including Amarillo-based Hastings Entertainment Inc. (Nasdaq: HAST), which operates 153 retail stores, and Colorado-based The Sports Authority, which operates 450 stores.
Energy management tools are growing in popularity as utilities become pressured to reduce peak loads. Such tools are especially useful with governments that operate dozens of buildings, said Beth Machen, senior vice president of the Institute of Real Estate Management and president of the Charlotte, N.C.-based Machen Advisory Group Inc.
“The main driving force will always be money,” Machen said. “It’s a growing trend that you’re going to see more and more of.”
ccalnan@bizjournals.com | (512) 494-2524
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Read more: Site Controls grows as it enhances clients’energy use monitoring - Austin Business Journal
TKOI could be looking for a buyer of their unique technology. A bigger player in the works soon!
ARNA Share Price Sept 15 2010 any guesses ill say $12
.0006 today!
PLGC ready to bounce!
PLGC ready for the bounce!
PLGC way over sold looking for a quick 5 bagger here by end of month!
27-Jul-2010
Bankruptcy or Receivership, Financial Statements and Exhibits
ITEM 1.03 BANKRUPTCY OR RECIEVERSHIP.
Playlogic Entertainment, Inc. (Nasdaq OTC: PLGC.OB), an independent worldwide publisher of entertainment software has announced today that it is has voluntary requested a delay of payments, 'surseance van betaling', the Dutch equivalent of Chapter 11, for its subsidiary Playlogic International N.V and her wholly owned subsidiary Playlogic Game Factory B.V.
ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS.
99.1 Press release of Playlogic Entertainment, Inc. dated July 27, 2010.
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PLGC looking for at least 3 bagger here ! by end of week!
PLGC will close @.036 with a little tender loving care. After this news and dumping emotion ends, we could see share price getting back to .12-.15
PLGC lod .017
PLGC complete loss bankruptcy possible company will PR by 07/30/2010
PLGC Current News 07/27/2010 View our E3 coverage Home News Features Resources Education Jobs
UpdatesPlease send any queries on account amendments to network@gamesindustry.biz
Matt Martin
Editor, GamesIndustry.biz 27/07/2010 @ 16:31
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Fairytale Fights publisher Playlogic recorded further losses for the first three months of the year, the latest in a trend that has seen the company haemorrhaging money.
In filings submitted to the SEC last month, the publisher revealed it made a net loss of $2.2 million for the period January to March 2010, and admitted that it is also defaulting on weekly loan repayments of €25,000, which it has been obliged to pay since April.
Playlogic claims that one of its main customers, distributor Koch Media, has not paid the company since December 2009, and the publisher is taking legal action for unpaid bills totalling €1.7 million.
The company admitted that to continue to operate for the second quarter of the year, it need to secure financing from third parties, which has not been forthcoming.
"If the Company does not obtain any necessary financing in the next month, we may need to cease operations," said Playlogic in June. For 2009 the publisher reported a full-year loss of $20 million.
Speaking to GamesIndustry.biz, Playlogic's Rick van Beem denied the company was bankrupt but admitted it was "facing tough times". A detailed update on the business is expected before the end of the week - the company website is currently offline.
According to Dutch site Control Online, in-house development studio Playlogic Game Factory in Breda continues to work on a number of projects, including an extension of EyePet for Sony Europe, providing work for around 30 staff. Tweekers.net is reporting that the company is filing for bankruptcy, which would put the 100-plus headcount at risk.
The company has six games in development including Crazy Garage and Young Archaeologist with French developer White Birds, and The Strategist from Canadian outfit Frima.
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160 million shares traded!
HFBG getting some love up 40%, This is only the beginning of a long ride up!