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whtmtn

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  • Zohydro: Should Politicians Be Able To Overturn An FDA Decision? [View article]
    They are and that is why they and the FDA have gone to extraordinary measures to prevent and control abuse. That can't be said for the other companies in the space that have products are in many cases stronger than Zohydro. Abuse deterrent or not, their products have been abused. Zogenix is asking for a level playing field. Why do you simply repeat the misinformation about strength? There are many other opioid products that are stronger the Zohydro and do not contain abuse deterrent technology, the value of which the FDA questions. Many people simply ingest the pills. The issue is ease of access.

    Conversely, you probably have no idea of the cost to society and the problems that arise from overuse of acetaminophen. Different patients respond to different medications and Vicodin is not appropriate for the treatment of chronic pain due to the high levels of acetaminophen. Knowing someone in great pain from recent cancer surgery, I can attest that these medications are invaluable. I firmly believe Zogenix is doing the right thing and believe that if the state of MA wanted to address their problem, they should look at the entire class of pain products and how they are controlled/distributed. Singling one company's product out seems highly ineffective (they haven't been part of the problem) and only political grandstanding in nature. Notice he didn't take on opioids made by other deep pocketed drug manufacturers. While the company is pursuing the patient's rights angle, I would also argue the state is also promoting unfair business practices (prohibiting competition) by unfairly discriminating against one company's product.
    Apr 8, 2014. 10:12 AM | 2 Likes Like |Link to Comment
  • Zohydro: Should Politicians Be Able To Overturn An FDA Decision? [View article]
    In speaking with surgeons and pain docs, they currently prescribe acetaminophen free hydrocodone through compounding pharmacies to patients who can't tolerate the acetaminophen. Zohydro provides an fda approved, fda regulated manufactured and controlled product. Safer alternative to compounding/off label use. The fda took the opinion of advisory committee into consideration with its approval but believed as the author indicates that the product is needed for patients (I would be curious to see the stats on patients with liver toxicity) and the current tamper resistant technologies are largely ineffective. The Purdue product will need to be significantly more powerful than Zohydro to provide the 24 hour ER and this would seem to me to present a significant safety issue, particularly in light of ineffective tamper resistance.

    It would seem to me that any bill to ban these products would need to be much broader than targeting one company's product. We would need to look at the class of opioids in their entirety, including generics and supposed tamper resistant products that are currently abused. I would think Zogenix would have a significant legal case were it to be singled out, not to mention the political conflict of interests that are rampant in this situation as well as the slippery slope of congress overriding the fda targeting one product from one company. Not likely to happen.

    The market value will take care of itself as the Company demonstrates revenue growth and continues to build out its pipeline.

    Mar 25, 2014. 09:17 AM | 6 Likes Like |Link to Comment
  • Pressure grows on FDA to revoke approval of Zogenix's Zohydro [View news story]
    Why not push for the ban of oxy? Why limit this to one Company? Also, seems to me that other large drug companies may be pushing for this news. Check out Pfizer's release:

    "Pfizer Inc. (PFE) said its treatment for chronic lower back pain met the primary efficacy endpoint in a Phase 3 study.

    The drug maker's investigational agent ALO-02 is an oxycodone hydrochloride and naltrexone hydrochloride extended-release capsule meant to treat people with moderate-to-severe chronic low back pain."

    Do you think they have an agenda?
    Feb 26, 2014. 11:29 AM | 7 Likes Like |Link to Comment
  • Nanosphere: The Next Cepheid? [View article]
    Smart move as here we are 1.5 years from the date of this article and still waiting for growth and profitability. This despite recent FDA approvals. I am hoping we get taken out but valuation looks steep on most metrics at the moment.
    Feb 24, 2014. 10:47 AM | Likes Like |Link to Comment
  • Nanosphere: The Next Cepheid? [View article]
    Any thoughts on this development with CPHD?

    SUNNYVALE, Calif., June 27, 2013 /PRNewswire/ -- Cepheid (CPHD) today announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert® MRSA/SA Blood Culture (BC) test, which runs on the GeneXpert®System, for the detection of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA, typically methicillin susceptible) in blood culture bottles showing gram-positive cocci in clusters in about one hour.
    Jun 27, 2013. 04:10 PM | Likes Like |Link to Comment
  • "I would not overestimate retail investors' knowledge of how this business works," says Scott Ulm, co-CEO of Armour Residential (ARR -1.3%). Income fans love mREITs (MORT -1.3%) but can suffer quick losses as rates rise. "We believe mREITs are not appropriate for most individual investors," says Edward Jones' Kate Warne, warning brokers to steer clients away from the sector. Ulm remains hopeful: "As bonds become cheaper, reinvestment becomes more profitable." Beneath a big rally for the averages, the sector is hit again today: American Capital (AGNC -2.6%), (MTGE -1.2%), Annaly (NLY -1.9%), Two Harbors (TWO -0.9%), Hatteras (HTS -1.9%), CYS (CYS -2.8%), Anworth (ANH -0.9%). [View news story]
    Comment re: tapering and labor market:

    Dean Maki, chief economist at Barclays, told CNBC that May's jobs report does little to clarify the Fed's next policy move even though Chairman Ben Bernanke had said he would reduce bond purchases in the next few months if employment levels stayed strong.

    "I think this will be seen as a report that's not convincing either way in terms of tapering," said Maki. "We think not until March of 2014. Our view is that the labor market and GDP will be slow enough that the Fed decides it's not worth tapering at this point and it's because we do not expect the bounce back to 3 percent (GDP growth) that they are expecting."

    Plenty of time for re-balancing a portfolio.
    Jun 8, 2013. 11:19 AM | Likes Like |Link to Comment
  • "I would not overestimate retail investors' knowledge of how this business works," says Scott Ulm, co-CEO of Armour Residential (ARR -1.3%). Income fans love mREITs (MORT -1.3%) but can suffer quick losses as rates rise. "We believe mREITs are not appropriate for most individual investors," says Edward Jones' Kate Warne, warning brokers to steer clients away from the sector. Ulm remains hopeful: "As bonds become cheaper, reinvestment becomes more profitable." Beneath a big rally for the averages, the sector is hit again today: American Capital (AGNC -2.6%), (MTGE -1.2%), Annaly (NLY -1.9%), Two Harbors (TWO -0.9%), Hatteras (HTS -1.9%), CYS (CYS -2.8%), Anworth (ANH -0.9%). [View news story]
    Don't forget they have hedged their assets with swaps, etc. While not wholly familiar with the details of their hedges, they basically use matched duration maturity treasuries to hedge for large moves in rates. Not to be elementary but the hedges increase in value as the mortgages decline in value. The duration gap was 0.5 years at the end of March. Treasury yields have increased in Q2 (unlike Q1) consistently with the increase in mortgage rates. The profits on the hedges offset the unrealized losses on the asset portfolio (maintaining book value). The yield curve, however has remained upward sloping and in fact, likely steepened as short term rates have remained low while longer term have increased. This is a point of increasing profitability/yield for the model.

    My main concern arises if the yield curve flattens and yields are reduced. This will be a function of rising short rates which is likely further off due to the fed policy. I believe even with a flatter curve they can likely generate a respectable return appropriately leveraged. Stock prices may bounce around some but the upward sloping curve will drive profitability and the Company will continually re-balance its portfolio and hedge position as asset prices/rates change. The better managers will be more successful during the transition from declining to increasing rates. This is an important asset class providing liquidity to the mortgage market (as GSE's hopefully wind down) and I don't see it disappearing. The managers of AGNC have managed much larger portfolios of mortgages in a variety of rate environments (albeit not at this low a level but both rising and falling).
    Jun 7, 2013. 11:55 PM | 3 Likes Like |Link to Comment
  • "I would not overestimate retail investors' knowledge of how this business works," says Scott Ulm, co-CEO of Armour Residential (ARR -1.3%). Income fans love mREITs (MORT -1.3%) but can suffer quick losses as rates rise. "We believe mREITs are not appropriate for most individual investors," says Edward Jones' Kate Warne, warning brokers to steer clients away from the sector. Ulm remains hopeful: "As bonds become cheaper, reinvestment becomes more profitable." Beneath a big rally for the averages, the sector is hit again today: American Capital (AGNC -2.6%), (MTGE -1.2%), Annaly (NLY -1.9%), Two Harbors (TWO -0.9%), Hatteras (HTS -1.9%), CYS (CYS -2.8%), Anworth (ANH -0.9%). [View news story]
    I believe it was foreign currencies as well. Also, I believe their leverage was far higher.
    Jun 7, 2013. 11:15 PM | 1 Like Like |Link to Comment
  • "I would not overestimate retail investors' knowledge of how this business works," says Scott Ulm, co-CEO of Armour Residential (ARR -1.3%). Income fans love mREITs (MORT -1.3%) but can suffer quick losses as rates rise. "We believe mREITs are not appropriate for most individual investors," says Edward Jones' Kate Warne, warning brokers to steer clients away from the sector. Ulm remains hopeful: "As bonds become cheaper, reinvestment becomes more profitable." Beneath a big rally for the averages, the sector is hit again today: American Capital (AGNC -2.6%), (MTGE -1.2%), Annaly (NLY -1.9%), Two Harbors (TWO -0.9%), Hatteras (HTS -1.9%), CYS (CYS -2.8%), Anworth (ANH -0.9%). [View news story]
    I am not sure of the point of this "news flash." Is it to help the poor retail investor out? The time to invest is when others are scared, not when everyone is investing. I question the intent of all of the warnings...we get it. If people aren't smart enough to know bond prices go down when rates go up then they shouldn't be reading this blog. The difference here is this is a hedged portfolio that invests largely in assets backed by the US government (i.e., low credit risk). I am not sure LTCM was investing in Agency MBS (correct me if I am wrong). I believe retail investors are panicked and we are oversold.
    Jun 7, 2013. 07:38 PM | 3 Likes Like |Link to Comment
  • Nanosphere: The Next Cepheid? [View article]
    Directionally correct but as we approach July 2013, I am not sure we are at break even. I would suggest perhaps by the end of the year if we are lucky. May even be an equity raise before then.
    May 27, 2013. 12:12 PM | Likes Like |Link to Comment
  • How Would The End Of The Fed's QE Affect Agency mREITs? [View article]
    AGNC actually had a slight negative duration as of April 30th implying an increase in rates would cause a slight increase in equity value. One has to acknowledge that duration is an estimate based historical assumptions and thus is subject to some variability, however, it is been used as a measure of risk for quite some time.
    May 23, 2013. 09:48 AM | Likes Like |Link to Comment
  • Prospect Capital: Record Originations Lack Income Punch [View article]
    Psec needs to either sell shares above book and deploy the capital at Net yields greater than 12% (tough to do) or issue more debt and invest at accretive yields. Otherwise, any equity offering will be dilutive to shareholders. Raising equity at or near book value and deploying at a net yield to shareholders of 12% only serves to benefit the management company in the form of more fee income...investors lose or break-even.
    May 13, 2013. 09:02 AM | 1 Like Like |Link to Comment
  • Prospect Capital: The Recent Weakness May Be A Buying Opportunity [View article]
    It is also significant dollars for the number of employees that work there.
    May 8, 2013. 03:40 PM | Likes Like |Link to Comment
  • Prospect Capital: The Recent Weakness May Be A Buying Opportunity [View article]
    Excellent points. The reason this trades at or below NAV is simple math. They cannot put assets on the books that drive a 13% yield without taking substantial risk. If their average cost of capital assuming 70% equity/30% debt is about 10%, fees are 2% and expenses add another 1%, they need to originate assets yielding 13% to cover the costs and pay the dividend. This is a very challenging task given the size of their fund and the competitive dynamics in the debt markets.

    I don't put much weight on their stock ownership given the size of the management fee and their likely compensation as a result of these fees. No one below Barry owns much equity nor have they purchased much--I really don't like the incentive structure created in an externally managed BDC. Goal is to raise AUM and incent for origination which can lead to a decline in credit quality.

    My view as to why they trade where they do has to do with the risks in their portfolio. They have several very large holdings and significant levels of equity and control investments. The BDC's that have traded at or below NAV and suffered significantly in the downturn had greater equity exposure and control investments. The better BDC's were more debt focused and had greater granularity (both quantity and industry) in their portfolio.

    Defaults may be low but I agree as rates rise or if the economy dips, their NAV will be more vulnerable to defaults and respective asset write downs. I also believe the market is overheated and terms (covenants) are in favor of the borrowers today.
    May 8, 2013. 11:35 AM | 1 Like Like |Link to Comment
  • Tesaro's Rolapitant: Investors Pay 17x Premium For Discarded Drug [View article]
    Don't forget NEA & KPCB were the investors behind TSRO. Unlike OPKO, they are an institutional investor in common stock. Not sure if you think they are also an uninformed as investors. They have significant capital invested in the common shares at increasing prices including at the IPO price.
    Apr 11, 2013. 04:06 PM | Likes Like |Link to Comment
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