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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
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  • $2500 to $100,000 blog 2/13
    Anybody unfamiliar with what we are doing here should read this link here.

    Today we made our first trade. JAZZ puts were purchased. The puts have an $11 strike price and September expiration. I bought them for $155 a contract. 10 contracts were purchased for a total of $1567.62 including commissions. Our starting capital was $2500.


    STARTING CAPITAL                                    $2500.00
    10 JAZZ PUT CONTRACTS                          -$1567.62
    REMAINING CAPITAL                                     $932.38



    I intend on closing out this option position in the $5 range Monday August 23rd.

    This has been blog 2/13


    Here is a screenshot of the filled order for those asking-

    Disclosure: bearish. puts bought.
    Tags: JAZZ
    Aug 18 1:37 PM | Link | 142 Comments
  • JAZZ will recieve an unfavorable response from the FDA panel and it's stock will collapse Monday. Only 2 days left to get out.

    I would like to open by saying that if you hold shares of JAZZ there will be nothing but tears, bloodshed and regret waiting for you Monday morning when the stock collapses around 50% and your portfolio is awash in a bloody mess of red ink. If you have not exited JAZZ or at least locked in profits then you should do so immediately. 

    My first article written here about JAZZ set to explain my belief that fibromyalgia is a very controversial disease with a contended legitimacy. In this article I would like to take a look at the statistics available on fibromyalgia and why this data will strongly work against a panel recommendation of JZP-6.

    Fibromyalgia is diagnosed and prescribed almost exclusively for women. In fact, the official ratio of women to men treated for fibromyalgia in 2009 was greater than 9:1. That means that over 90% of those diagnosed with fibromyalgia were women. Fibromyalgia has been diagnosed in approximately 2% of the US population(309M). That's a deceptive way of putting the numbers. Because 90% of fibromyalgia patients are women that means almost 4% of the entire population of women in the United States suffer from fibromyalgia. People have been foolishly quick to point out that JAZZ's drug candidate JZP-6(GHB) has already been approved to treat narcolepsy under the brand name Xyrem. This is true but let's crunch the numbers. Only 50,000 people in the United States have been diagnosed with and are currently being treated for narcolepsy. Only half of all narcoleptics are being treated with or have been prescribed Xyrem. 
    Thats a very small population half of which are men. That means 25,000 women in the US have narcolepsy. Comparing the patient populations of fibromyalgia and narcolepsy is similar to comparing K2 to Bunker Hill. Fibromyalgia affects ~6,000,000 women and narcolepsy affects ~25,000 women. The comparisons between these two diseases has got to stop. The amount of women suffering from and diagnosed with fibromyalgia in the United States is the same size as the amount of women diagnosed with diabetes in the United States. 

    There is absolutely no data on how HGB affects fetal development and birth. The most detailed gestational studies were for Xyrem and even then they were only on animals as read in this link-

    For a disease which affects exclusively women this will weigh heavily on the FDA panel's decision. Add to that the serious withdrawal symptoms, addictive nature of the drug, deadly effects when mixed with even small amounts of alcohol, and the dispute of the disease's legitimacy, JZP-6 is looking almost ridiculous. The silver lining on the pregnancy and fetal development issue is the fact that the majority of those diagnosed with fibromyalgia are over age 35 which helps mitigate things somewhat although not nearly enough in my medical opinion. I have yet to find a doctor that can accurately prognos and distinguish between a patient with fibromyalgia, cfs, me, ibs, or has just worked out. If you find a doctor that can and they are confident in doing so then it's likely they had a visit from a well spoken pharma rep previously. The closest thing related to JAZZ's situation that I can think of was Hemispherix Biopharma's attempt to get regulatory clearance
    for their controversial drug candidate Ampligen. Ampligen was seeking approval for the treatment of chronic fatigue syndrome (CFS). They were denied. Ampligen is relatively benign compared to JZP-6 and was attempting approval to treat an affected population much smaller than that of fibromyalgia.  

    I find it interesting that Frederick Wolfe, who is largely credited with getting fibromyalgia recognized as a disease now rejects his own work and is disgusted with where fibromyalgia has been taken. This is an excerpt from the American Journal of Medicine-

    "According to Frederick Wolfe, highly cited fibromyalgia researcher and lead author of the 1990 paper that first defined the ACR fibromyalgia classification criteria, "the large majority of physicians, sociologists, and medical historians"[11] are skeptical about the validity of fibromyalgia as a clinical entity.[139] Some call fibromyalgia a “non-disease”[19] and “an over-inclusive and ultimately meaningless label.”[140] Wolfe now questions the validity of fibromyalgia as a disease. He considers fibromyalgia a physical response to stress, depression, and economic and social anxiety,[141] and believes the associated symptoms are a normal part of everyday life. In 2009, he wrote, "the tendency to respond with distress to physical and mental stressors is part of the human condition."[142] Wolfe and other opponents of the fibromyalgia concept say that labeling fibromyalgia as a "disease" simply legitimizes patients’ sickness behavior, slowing
    their recovery and harming them.[19]"

    Jazz has continued it's runup from the $9's as predicted in my first article. My target options "close out" price is still $5. I see the CBOE is pegging the pps to either go up to $15 or down to $5 from a strangle spread with an approval or rejection. I see a strong panel vote against JZP-6's approval. When the bloody mess of red ink is mopped up from shareholders and the computer screens cleared of all debris left by exit wounds they will show a 250% or more profit for those prudent enough to buy puts. I will be buying puts for JAZZ either Wednesday or early Thursday. I'm currently involved in a project to turn $2500 to $100,000 here. I am looking at either $10 or $11 strike price puts with a September expiration. There are two reasons I have not bought puts yet: One, it has not been established whether JAZZ's stock will be halted all day long or will resume trading late in the day Friday. If I find out from my sources within the next 48 hours that it will be resumed I will buy $10 strike Aug 20th puts. Second, is that I am anticipating that the FDA briefing documents won't raise any questions not already discussed and JAZZ may head back to the $11 area (give or take) making puts all the cheaper. To all followers following the $2500 to $100,000 blog series I will author a blog either Wednesday or Thursday as soon as I make the first trade. Stay tuned and stay away from any positions in JAZZ that are not bearish. 

    Now let's talk about the available data on JZP-6. JAZZ is attempting to "sneak" JZP-6 in via the 505b2 NDA meaning that instead of a regular 505b1 NDA they submited one for a drug (JZP-6) based on an already approved drug (Xyrem). Jazz's phase III trials although reaching statistical significance over placebo were FAR too short. Two phase III trials were conducted over a paltry 14 week period each. I hope people heard me correctly because I in fact did say "14 weeks". I will say it again so there is no possibility of confusion: 14 WEEKS. Combined, that's a phase III trial that lasted for half a year. The patients participating in the trials encountered AE(adverse events) and side effects at over double the rate of the placebo group. We are talking about a schedule 1 drug that had a 6 month trial. Is JAZZ waiting to deliver the punch line at the panel? To anybody in the medical field or familiar with the FDA, JAZZ's trial and data is laughable. In fact, there is really nothing there for me to see or read. The JZP-6 trials were so ridiculously vacuous that I actually had to go back and read the Xyrem trials and prescription labels to get an idea of what the outcomes were and what's going on-

    Again, I will reiterate the fact that JAZZ is attempting approval of a hard-core illegal Schedule 1 drug for a disease that has legitimacy issues, has no longterm safety data, has no pregnancy data, is not life threating, which has several other treatment options, and had very limited trial duration. We all know about fibromyalgia's classification and the 9 paired tender points. The only thing going through my mind after hearing "tender points" isn't the plight of fibromyalgia patients but how much JAZZ's stock will look like over fried tender loins come Monday.

    I spoke to a colleague who said France is using GHB on patients during pregnancy. I corrected him by saying it was not administered during pregnancy but birth. Doctors intravenously administer it during birth to relax the woman's cervical muscles. Even this is controvertial as the children born often recieve lower RDS scores after birth and are closely monitered. Because of GHB's short half-life they are usually fine. Think about that: GHB acts so quickly and is so powerful that it can affect a baby during delivery. What fetal results will consistent use of GHB during pregnancy yield? Let's not forget the majority of women are unaware they are pregnant for 4-6 weeks and sometimes much longer. Are there drug interactions between (the pill) and GHB? Alot of questions remain on this drug and you can bet the panel will ask them. Unfortunately for shareholders, JAZZ won't be able to answer them.

    Disclosure: Very bearish. Will be buying puts-
    Tags: JAZZ, HEB
    Aug 17 7:16 PM | Link | 55 Comments
  • Telsa Rowe to turn $2500 into $100,000 in 3 months and 8 total trades. Blog 1/13
    What I love about biotech more than any other sector is it's volatility which can be profited from regardless of which way its chosen security moves. Biotech is a sector that allows options to be profited from more so than any other sector. I also love the fact that biotechs have staid action dates (FDA panels, pdufa's, phase result presentations, etcetera). With these staid action dates one can begin research and DD on a wide range of biotechs and select the ones they like or dislike. From there one can develop his trading strategy far in advance modifying it slightly with the news updates on the chosen securities. 

    I took a bet the other day from a colleague. He said it's impossible for the individual trader these days to make more money with their funds than proffesionally managed funds can for them. He said Wall Street is rigged. My arguement was that if it (Wall Street) was rigged it was irrelevant because traders enjoy the freedom to utilize tools to make money when stocks go up (calls, buying stock) or down (puts, short stock) or even sideways(certain option spreads). I bet him that I could turn $2500 into $100,000 in 3 months. I was met with laughter. I wasn't laughing because I knew I had done it before on more than one occasion. This will be 1 of approximately 13 blog entries chronicaling my trades over the next 3 months. To make things harder for me and easier for you let's set some rudimentary rules:

    1. There must be no more than 8 total trades
    2. No pennystocks
    3. No daytrades

    I do not ask that anybody mirror my trades at all as my positions will carry CONSIDERABLE risk. I do ask that you follow my progress and check in to see how it's going every so often. To say I was not aware of the trades i will make already is a lie. I spent most of July researching, pouring through clinical trial data, TA, chatting with experts, and finding FDA trends. My next 3 months consist of 8 total trades (a buy and then sell of same security is considered 2 trades).

    1) Buying puts for JAZZ going into their panel meeting
    2) Buying puts for ARNA going into their panel meeting
    3) Buying calls for BIOD going into their PDUFA

    There has been some criticism of my vociferous parlance as of late but that will be inaudible after I will smash the professionaly managed funds returns over the next 3 months and validate my authenticity. NOTHING but embers will follow this deathmarch. After I turn $2500 into $100,000 I will then begin a second part to this turning $100,000 into $1,000,000. Enough with the talking and bullshit general market discussions which foolishly dominate seekingalpha. Its time to make money and witness somebody actually put their money where their mouth is. That somebody is me.

    I will author a blog before each option trade execution and include a screenshot.. Again, my starting capital is $2500. This has been blog entry 1/13. 


    Disclosure: positions forthcoming
    Tags: JAZZ, BIOD, ARNA
    Aug 11 9:31 PM | Link | 59 Comments
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