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Telsa Rowe
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Nutritionist/MD/Biotech investor. I have little time to discuss the general market, anything I cannot change or other irrelevant topics that dominate seekingalpha and are the products of its top 100 members. I put my money where my mouth is and adhere to sound DD. Capitalism favors the bold and... More
  • I'm going to just say it: Mannkind is garbage 34 comments
    Aug 8, 2010 1:14 PM | about stocks: MNKD, BIOD


    Before the FDA packs up and takes it's Christmas hiatus they have an important decision to make: Approve Afrezza or don't. Although the PDUFA is scheduled for December 29th I expect one of two scenarios to play out: Either the PDUFA decision will be mailed just before Christmas as is the case for many action dates around this time or they will announce that a recommendation panel is to be convened. Mnkd's recent NDA resubmission was filed as a class 2 by the FDA. This link explains in detail the NDA classification system

    http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079303.pdf


    In my experience, most class 2's recieve a panel. If a panel is convened then the PDUFA will likely be pushed 6 months back to about June 2011 with the panel meeting a few months prior. Besides the obvious delay, what's unfavorable about this to shareholders is that ~$200M worth of debt obligations will have to be satisfied in that time.

    Mannkind seems to be in a shell game of opposites that swiftly collapses into a singularity with a competing company-Biodel. Biodel was founded by Dr. Sol Steiner and Mannkind was founded by Alfred Mann. Dr. Sol Steiner and Alfred Mann were educated on opposite coasts. Dr. Steiner attended NYU and Alfred Mann attended USC. Both of their companies are located on opposite coasts. Biodel is based out of Connecticut and Mannkind in California. Dr. Steiner is a Republican and Alfred Mann is a Democrat. Both company's lead drug candidates seek to deliver prandial insulin in opposite ways. Biodel's VIAject is subcutaneous and Mannkind's Afrezza is inhaled. The differences however begin to implode rather quickly from here. Both companies lead drug candidates seek a share of the same market-mealtime insulin. Furthermore, Alfred Mann and Dr. Steiner used to work with one another. Dr Steiner is the inventor of his rivals drug candidate Afrezza(technosphere T1 insulin powder). Even more interesting is that up until mid 2009 Biodel's Danbury CT facility manufactured Afrezzas active ingredient Technosphere insulin (T1) for their trials. Dr. Steiner was paid handsomely before signing all technosphere intellectual property and company (Pharmaceutical Discovery at the time) over to to Mannkind. He (Dr. Sol Steiner) immediately fouded a new company (Biodel) and in a matter of years has developed an immpressive drug pipeline and secured important intellectual property for 4 potential blockbusters

    VIAject- ultra fast prandial
    VIAtab- type II sublingual insulin 
    SmartBasal- self regulating basal
    Glucagon- stable glucose recovery suplement

    I find it impressive that Biodel has done so much so quickly all the while maintaing it's fundamentals and capital position well. They also will seek the NDA 505(b)(2) route with most of their products which should lead to faster pipeline development because of smaller trial requirements. Im curious to why technosphere's inventor would walk away from it so hastily if it is in fact as big as the media and investment community have tried to foist upon us. It could be rooted in a great Roman generals maxim "I would rather be the leader of a small group of savages than second in all of Rome". It is unclear at this point however which company represents Rome although evidence in the form of pipeline, fundamentals and achievement strongly favor Biodel.
     
    Back to Mannkind, if there is no panel requested by the FDA I would look at it as a bad thing as the FDA will likely request more information. I find it foolish that Mannkind did not attempt to be label specific in their NDA to begin with. What I mean is that after discouraging trial data for control of HbA1c in type 1 diabetics I think it would have been prudent to concentrate on only early stage type II diabetics and seek additional indications afterwards. Instead they seek a broad label including diabetics of all  types and ages with basic exclusions for those with pre-existing pulmonary/lung conditions. This is a recipe for disaster. VVUS is one recent example of this. Pulmonary safety is going to be a huge hurdle for mnkd to cross because it's phase 2 and 3 data has already hinted at potential problems. 2.9% of all phase 2 and 3 patients recieving Afrezza quit their trial because of severe cough (made all the more statistically relevant by the fact that the Lispro group couldn't have this problem so there were no dropouts). Too, small decreases in lung function were noted as early as 1 year when trial participants quit using Afrezza. Although lung function returned to normal within 3 months after resuming treatment one has to really think like the FDA 10 or more years down the road. Although the lung is a forgiving organ because of its rapid mitotic division it is very susceptible to synthetic particles. Another issue talked little of is insulin degradation. Technosphere, although needing no refrigeration is highly reactive to heat as are all insulins. Where as injectable prandial's drill of refrigeration is established and adhered to by diabetics, there will no doubt be the occasional Afrezza left in the sun, in the hot car or pocket for too long. I don't know how this changes the pharmacokinetics but it certainly isn't safe as are compromised injectable prandial's.  Afrezza's dosing is particularly particularly disturbing. A full grown male will be required to take a staggering 30U's. Humalog's dosing for a full grown male is less than half that. To put double the amount of insulin in one's lungs several times a day should worry some considering long-term safety has not been established. 

    Doctors and diabetics want faster acting prandial insulins and most of them agree that there is an unmet need for them. However, diabetics and doctors have little interest in Afrezza's type of insulin delivery as evidenced by the truncation of the major pharma companies inhaled insulin programs. A recent physician poll done by consultants for Biodel revealed that 99% of them agreed that there was an unmet need for fast acting prandials and 98% of them said they would prescribe VIAject.

     I recently chatted with an individual that participated in Afrezza's phase 3 trial for type II diabetics. He said the insulin worked a little better than Apidra(prandial he takes) but that he would not use it if it were commercially available. He said the dosing was confusing (although Mannkind seeks to address this with the dreamboat inhaler), he had a perpetually runny nose and about a 30 min tickling sludge feeling in the lungs. Because he lives in the frosty midwest, whenever he would go out into the cold and breathe in the cold air after being indoors he would cough for a couple minutes uncontrollably. He said for all its seeming convenience it was less convenient than his injections. I asked if he would be interested in VIAject after explaining it to him and he said he would be knocking down his doctors door to get it. People who are not diabetics often think diabetics are fearful of needles because THEY themselves are. Modern pen-injectors are nearly painless and the next generation of needless jet-injectors may render Afrezza's claimed convenience completely irrelevant. I wrote an article about that here.

    I see a blue Christmas for Mannkind shareholders as the company and their drug candidate face multiple problems any of which could have a significant impact on it's share price. Although I have no position as of yet, I will certainly consider a bear option spread as the winter nears. With shares currently trading around $7.00 and no news expected for months (unless FDA panel or dilution news both of which are pps negatives) shares of Mannkind could be at the mercy of the general market or even worse...daytraders. Mannkind has a large mkt cap, huge debt overhang, potential PDUFA date delay and it's competitors technology kettleing. Without an Afrezza approval within 12 months I think Mannkind is a bankruptcy candidate. Most people will be quick to point to Alfred Mann saving the company but I doubt it. Alfred Mann for all his charity work is a capitalist first and certainly not retail shareholder's buddy although that is exactly what the company would like shareholders to believe. As macabre as it sounds, Alfred Mann is nearing 90 years of age and could potentially die any given day as the math favors it to be sooner than later. Now could be the right time to swap a position in Mannkind for a position in Biodel. If not, shareholders may find themselves decking the halls with boughs of folly this Christmas. 
     






    Disclosure: no positions
    Themes: Biotechnology Stocks: MNKD, BIOD
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Comments (34)
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  • WCoastGuynCA
    , contributor
    Comments (297) | Send Message
     
    I think "BP" offers more upside than "BIOD".
    8 Aug 2010, 02:32 PM Reply Like
  • bluestocking1
    , contributor
    Comments (17) | Send Message
     
    Obviously, Mr. Rowe, you are in Biodel, which is why you want the rest of us in MNKD to switch. I refuse to listen to you b.s. and I hope others in MNKD do the same.
    By the way, my four year old would love to have NO NEEDLES for her diabetes.
    8 Aug 2010, 03:13 PM Reply Like
  • aampus
    , contributor
    Comments (7) | Send Message
     
    You failed to mention a few simple facts:

     

    1) Viaject requires titration and carb counting, Afrezza does not.

     

    2) The pharmacokinetic profile of Viaject is better than that of hexameric insulin, but clearly inferior to Afrezza.

     

    3) The Phase 3 clinical trial of Viaject was not only unusually small in numbers, but it used RHI (outdated insuling used only in 3rd world countries nowadays) as the control to which the trial was designed to show equivalence. This means that Viaject has not even EQUIVALENCY data to the current gold standard (injected Rapid Acting Analog insulin). Thus, the label of Viaject will be highly inferior to that of Afrezza.

     

    4) Approval of Viaject at the first go around is highly unlikely due to small patient number, problems with Indian results, and an overly aggressive regulatory approach. How will Biodel stock fare if and when FDA requires additional clinical data and a substantial amount of new funding will be required?

     

    5) Some of your allegations regarding Mannkind are so amateurish and outlandish they do not even merit comment.

     

    You are a pump-and-dump amateur, clueless as to your own ignorance.
    8 Aug 2010, 03:40 PM Reply Like
  • weargue
    , contributor
    Comments (58) | Send Message
     
    everyone on the planet injects themselves with insulin.
    as far as putting crap into your lungs, NEKTAR proved that won't work.
    your lungs are very fragile and you should NOT screw around with them.
    9 Aug 2010, 12:09 PM Reply Like
  • Telsa Rowe
    , contributor
    Comments (86) | Send Message
     
    Author’s reply » Rapid acting insulin was not used in trials of viaject? Fella, I am a diabetic myself and can tell you that novolog, humalog, and apidra are nearly indistiguishable by most diabetics. They act nearly at the same speed and control hba1c nearly the same. The thing with VIAject that makes it so desireable is it's speed and highly reduced IU's per injection. I won't use Afrezza for multiple reasons safety being number one. You don't care about safety because you won't be using any of them. If you were then the safety issue may cross your mind. To the individual saying they would give Afrezza to their 4 year old. Really? Really now? Laissez-faire but not on this issue. Longterm safety IS NOT ESTABLISHED.
    8 Aug 2010, 04:41 PM Reply Like
  • weargue
    , contributor
    Comments (58) | Send Message
     
    you are right on track. ignore these lung-damage-promoting people.
    9 Aug 2010, 12:10 PM Reply Like
  • pmoore22
    , contributor
    Comments (19) | Send Message
     
    Telsa -- anecdotal evidence from some guy in the midwest is not very convincing. Here is a study showing that 93% of trialists had very positive experiences with afrezza. Don't let data get in the way of a good idea, right?

     

    www.liebertonline.com/...
    8 Aug 2010, 04:49 PM Reply Like
  • Ahpla68
    , contributor
    Comments (8) | Send Message
     
    Five followers. Yes, I see why.
    8 Aug 2010, 05:10 PM Reply Like
  • aampus
    , contributor
    Comments (7) | Send Message
     
    Telsa,

     

    First, I am not your fella.

     

    Secondly, you mention novolog, humalog, and apidra. In the Viaject Phase 3 pivotal trials HUMULIN (a RHI) was used for comparison, you knew that, right? So are you saying Humulin is the same or similar to RAA insulin?

     

    Thirdly, I greatly care about safety for any new medication, as does the FDA. For that reason, I believe Biodel will have to produce safety data regarding the injection of an insulin mixture that contains EDTA three times a day. There are extensive safety data regarding Afrezza. Where are the Viaject/EDTA data? What about the issue of soresness at the injection site? It seems that with only a few hundred patients in their study, BIOD had a remarkably large number of problems compared to 5000 Afrezza subjects. Not even to mention the issue of the Indian data.

     

    A last comment: You deride Al Mann as not caring for shareholders. How idiotic considering his track record wrt his shareholders. Plus, he owns close to 50% of Mannkind shares himself.
    8 Aug 2010, 05:12 PM Reply Like
  • Telsa Rowe
    , contributor
    Comments (86) | Send Message
     
    Author’s reply » Good lord where to start. Biodel is seeking a 505b2 NDA. Why? Because VIAject is Humulin with small catalysts added. You are going to sit here and try to tell me that Apidra, Humalog or Novolog are much different than Humulin? Yes they are, their safety data is about 80 years less. They all suck in their own way. VIAject takes the safety of humulin and adds with it 2x the speed of Apidra.
    8 Aug 2010, 08:48 PM Reply Like
  • aampus
    , contributor
    Comments (7) | Send Message
     
    Oh, by the way Telsa, could you please clarify your disclosure statement?

     

    Do you hold either, BIOD or MNKD, short or long?

     

    Thanks!

     

    P.S.: I am long MNKD, and I have no position or interest in BIOD.
    8 Aug 2010, 05:29 PM Reply Like
  • weargue
    , contributor
    Comments (58) | Send Message
     
    yes, you are a lung damage promoting promoter.
    9 Aug 2010, 12:11 PM Reply Like
  • JPG101
    , contributor
    Comments (169) | Send Message
     
    I always enjoy reading a different perspective then mine. And yours certainly is very different then mine. A few questions if I may?

     

    Biodel had some data 'issues' in India did they not?
    Biodel changed the way they made their medication during the trial because of severe pain issues did they not?
    You said Afrezza needs 30 units. How many units does Biodel need? Was there a change in dosing after the change in formulation?
    Could the FDA think any one of these issues could be a problem?
    I know you must be very busy but wouldn't these minor issues at least merit mentioning in your in depth look at Mannkind and Biodel?

     

    When should I take a short position in Mannkind?

     

    Alfred Mann almost 90? Yeh and he will be 100 in 15 years. I'm sure he's building Mannkind to get rich because he needs the money. He will surely, as you say, cut his losses, as a good businessman would do while being on the verge of approval and spending nearly a biliion dollars. As an unrelated side note Mann just pledged a few days ago to give away 90% of his money. There were news reports in a few obscure newspapers and small cable news organisations about this so I'm not surprised you missed all of this. He and a few other unknowns (Buffet, Gates, Rockefeller, Turner, Bloomberg , Ellison, Lokey amongnst them) were mentioned.

     

    www.nytimes.com/2010/0...

     

    Guess what Mann said he wants to do with the money he will be giving away? I guess you are right: he isn't a very good businessman! Just to make this a bit interesting I'm not giving you the reference on this one...

     

    Hope to hear from you soon!

     

    Thanks,

     

    JPG
    8 Aug 2010, 06:28 PM Reply Like
  • Telsa Rowe
    , contributor
    Comments (86) | Send Message
     
    Author’s reply » Reformulated VIAject???? Reformulated? They changed the ph by adding 1/2 cc of water. Water. Is water a schedule 1 drug? Has it been shown to be toxic recently? Water. We are talking about water here. Your body is made of 65% water. Water.

     

    You obviously have not done any DD. VIAject requires 3U-4U per dose.
    8 Aug 2010, 08:38 PM Reply Like
  • Telsa Rowe
    , contributor
    Comments (86) | Send Message
     
    Author’s reply » EDTA? Do you know anything about this chemical.? You know its approved by the FDA for injections 1000x the concentration of that in each shot of viaject right? You are aware that a can of pepsi has 2x the amount of EDTA than each shot of viaject right? You are aware that Biodel has completed an EDTA trial for stress on blood vessel walls as well as a longterm 18 month safety study right? You know it is considered GRAS and is in everything in your household from shampoo to yougurt right? You are aware that EDTA has been shown to be healthy for your pulmonary system when injected in moderate doses right? You are aware that EDTA chelates the zinc in the insulin hexamer resulting in almost zero net EDTA in a patients bloodstream after each injection right? No I dont think you are aware of what you are trying to pass off as genuine here. EDTA is healthy in the amounts used in each viaject dose and is an absolute non issue. The FDA gave MNKD a class 2 for their NDA resubmission. If that does not tell you anything then do some DD. O
    8 Aug 2010, 08:33 PM Reply Like
  • JPG101
    , contributor
    Comments (169) | Send Message
     
    Again not very polite.
    You should seek medical help I think...
    You have just lost one of your 5 only followers!

     

    Bye
    8 Aug 2010, 10:00 PM Reply Like
  • robdoc
    , contributor
    Comments (105) | Send Message
     
    I was trying to follow your points and arguments up until the point that you stated "STFU".
    Do you really feel that this is appropriate?
    You seem to be fairly passionate about stocks that you hold no position in.
    Are you being disingenuous as well as lewd?
    9 Aug 2010, 12:43 AM Reply Like
  • weargue
    , contributor
    Comments (58) | Send Message
     
    these people don't care about your disease. they only care about their investment.

     

    save your effort.

     

    they don't care about your lungs.
    9 Aug 2010, 12:13 PM Reply Like
  • aampus
    , contributor
    Comments (7) | Send Message
     
    So EDTA is no safety issue at all... and Biodel has 18 months safety data. Acidity, soreness at the injection site.... no issue at all... and only 500 patients.

     

    Yet you idiot reject Afrezza out of hand because of safety concerns when there are over 5000 patients with far less side effects than in your 500 Viaject patients.

     

    The point being that YOU, the Biodel pumper, attacked MNKD on safety grounds in order to pump your stock.

     

    Now do you want to comment on your lack of understanding of what is RHI vs. RAA and the nature of the Viaject phase 3 trials? Or are you already conceeding that you are just an ignorant uninformed pumper?

     

    And again, your disclosure states no position in Mannkind. What about your position in Biodel? Why are you not answering that question?
    8 Aug 2010, 09:00 PM Reply Like
  • sxiao
    , contributor
    Comments (28) | Send Message
     
    1. “In my experience, most class 2's recieve a panel. If a panel is conviened then the PDUFA will likely be pushed 6 months back to about June 2011 with the panel meeting a few months prior. Besides the obvious delay, what's unfavorable about this to shareholders is that ~$200M worth of debt obligations will have to be satisfied in that time.”

     

    a. In terms of a panel, this is a quote from Dr. Peter Richardson when he was asked about whether there would be a panel

     

    “We have had clear instructions from the agency, that’s not their intent.”

     

    b. Mannkind has no debt that requires principal repayments by June 2011. Just look at their June 10-Q. Mannkind has two sources of debt. Its loan from Al (due December 31, 2011) and its senior convertible notes (due December 15, 2013).

     

    2. “Another issue talked little of is insulin degradation. .....I don't know how this changes the pharmacokinetics....”

     

    Exactly. You don’t know. End of story.

     

    3. “As macabre as it sounds, Alfred Mann is nearing 90 years of age and could potentially die any given day as the math favors it too be sooner than later.”

     

    While Mr. Mann is still involved in the company’s affairs, the team he has built around him are doing the lion’s share of the work. Moreover, recent conference calls and company presentations are evidence that the President/COO and CSO are taking a larger role. This isn’t an APPL and Steve Jobs.

     

    4. “Alfred Mann for all his charity work is a capitalist first and certainly not retail shareholder's buddy although that is exactly what the company would like shareholders to believe.”

     

    The fact remains that Mr. Mann has provided a $350 million loan facility to the company and in addition to this, Mr. Mann has subscribed to various follow-on offerings. He’s putting his own money on the line right along side retail shareholders so your comments are just hot air.

     

    5. “He (Dr. Sol Steiner) immediately fouded a new company (Biodel) and in a matter of years has developed an immpressive drug pipeline and secured important intellectual property for 4 potential blockbusters”

     

    Didn’t you bother to listen to the last set of conference calls for Biodel? Sol clearly indicated that the market potential for certain of their potential products were not in the “blockbuster” range. So your comments contradict the Company’s own statements.

     

    6. By the way, I’m long BIOD, but in summary, this is a pretty sloppy article. Many factual mistakes and by the way, a whole bunch of spelling and grammatical mistakes.

     

    1. It’s vs its
    2. Conveined vs convened
    3. Recieve vs receive
    4. Company’s vs companies
    5. Fouded vs founded
    6. Immpressive vs impressive
    7. Suplement vs supplement

     

    There are more but I’ve lost interest in pointing them out.
    8 Aug 2010, 09:55 PM Reply Like
  • Telsa Rowe
    , contributor
    Comments (86) | Send Message
     
    Author’s reply » blog not english thesis.
    9 Aug 2010, 12:30 AM Reply Like
  • aampus
    , contributor
    Comments (7) | Send Message
     
    It is neither a blog nor an English thesis, it is a poorly disguised and primitive pumping scheme of one stock at the expense of another. Same as what Joseph Kruger did a while ago.... and many retail investors fell for it and lost money.

     

    The fact that you cannot be bothered to check you spelling (or don`t know how to?) in a public blog says something about your sense of quality.

     

    The fact that you lie and distort, and refuse to disclose your true position in BIOD, makes you a con man.

     

    The fact that, in order to pump up BIOD and make a quick buck, you discredit MNKD and a product that holds the promise of improving the quality of life for millions of diabetics makes you ..... a scumbag? Or do you want to suggest another word yourself? This pump job is certainly not in the spirit in which Biodel and Mannkind are or should be competing.
    9 Aug 2010, 04:30 AM Reply Like
  • josbo
    , contributor
    Comments (31) | Send Message
     
    "In my experience, most class 2's recieve a panel."

     

    Can you tell us what your experience is with respect to being someone that can speak to the viability of diabetes therapeutics? And should your experience count over the judgment of anyone else?
    10 Aug 2010, 09:26 AM Reply Like
  • Prmco
    , contributor
    Comments (5) | Send Message
     
    Why the tremendous anger about MNKD. Calling it garbage? Such certainty about an FDA panel? Why don't you own BIOD? Your profile says you're a research analyst with a small boutique?In your own living room.

     

    An emotional rant without intellectual content or analysis.
    10 Aug 2010, 12:02 PM Reply Like
  • Telsa Rowe
    , contributor
    Comments (86) | Send Message
     
    Author’s reply » Yes my boutique is in my house. It may be funny to you but my group has almost $20M in equity which is not funny. That amount stands to be potentially doubled by betting against jazz, doubled again betting against arna, and doubled again betting against mnkd. Still laughing? Well in april the fund had $5M and thanks to itmn and the dog known as vvus thats no longer the case. While folks like you are thinking about what new TV to buy folks like me will be trying to decide between the Gulftream G650 and the Dassault Falcon 900LX. This is investing where one's parlance is irrelevant. Good luck fella.
    10 Aug 2010, 03:41 PM Reply Like
  • robdoc
    , contributor
    Comments (105) | Send Message
     
    How is it that you plan to double your money betting against MNKD when you hold no position?

     

    You are either doing something altogether odd or being disingenuous.
    11 Aug 2010, 11:26 AM Reply Like
  • josbo
    , contributor
    Comments (31) | Send Message
     
    So while you are not short Mannkind you must hold puts on Mannkind? Or else why bother to have such a strong opinion on an issue where you have no stake? And since you made all these perfect calls doubling your money several times (you suggest four stocks that you made a killing on) so as to increase your funds to $20K. So you have puts on MNKD at $12? Have you sold yet? Or are you still short waiting for it to go to zero? Now I understand why you're so pissed. MNKD just won't cooperate and go to zero like you want it to.
    10 Aug 2010, 11:39 PM Reply Like
  • Telsa Rowe
    , contributor
    Comments (86) | Send Message
     
    Author’s reply » I hold no poistion in mannkind yet. I'm waiting to buy puts for when mnkd starts to move up going into one of its action dates (dec 29, or panel next year) as any savvy investor would do.
    11 Aug 2010, 09:12 PM Reply Like
  • robdoc
    , contributor
    Comments (105) | Send Message
     
    And no position in BIOD?
    12 Aug 2010, 01:14 AM Reply Like
  • Telsa Rowe
    , contributor
    Comments (86) | Send Message
     
    Author’s reply » No position in biod but I will have one soon. Its part of the $2500 run to $100,000-

     

    seekingalpha.com/insta...
    12 Aug 2010, 09:41 PM Reply Like
  • Supply side
    , contributor
    Comments (17) | Send Message
     
    Do you have a position in JAZZ?
    15 Aug 2010, 12:50 PM Reply Like
  • Telsa Rowe
    , contributor
    Comments (86) | Send Message
     
    Author’s reply » This week. $11 strike Sept exp options finaly got put on the board by the cboe so I will buy them this week and will blog before I do with a screenshot of the trade after I do.
    15 Aug 2010, 05:15 PM Reply Like
  • tonythefreak
    , contributor
    Comments (20) | Send Message
     
    You can't even create a false ID properly!

     

    www.google.com/#hl=en&...
    18 Aug 2010, 07:23 PM Reply Like
  • J.P. Zaragoza
    , contributor
    Comments (191) | Send Message
     
    Nice post here: www.tapebeat.com/20100...
    19 Aug 2010, 10:25 AM Reply Like
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