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Mike Havrilla  

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  • Updated FDA Decision Calendar: Five Decisions Before Year-End [View article]
    I agree with Adam Feuerstein's analysis of NFLD's Phase 3 trial for PolyHeme below:

    Also, the death rate for PolyHeme was 37.5% higher than the control arm in the Phase 3 trial when all 712 patients are analyzed and 18.7% higher when the 126 protocol violators are removed, which is in-line with the numbers reported in the JAMA meta analysis

    712 patients: 349 got PolyHeme, 363 standard of care --> 46 patients died from PolyHeme arm (13.2% rate) vs. 35 died in control arm (9.6% rate) missed statistical gaol of non-inferiority

    Excluding 126 protocol violators (18% of the patients in the study) --> leaves 586 patients to analyze resulting in 10.8% death rate for PolyHeme vs. 9.1% in control arm, which results in achieving the non-inferiority goal for statistical analysis for PolyHeme

    Among the 126 pateients excluded for protocol violations --> 23% death rate for PolyHeme (17/70) vs. 12.5% for control arm (7/56)

    NFLD got a nice pop on acceptance + priority review yesterday so you were right to be long. However, the FDA typically prefers intent to treat analysis which better reflects real world conditions, especially in the case of emergency medical treatment such as the PolyHeme trial so I don't think they will accept the exclusion of 126 protocol violators to achieve non-inferiority.

    I have not traded or invested in NFLD long or short, but it looks like most people are taking their profits today with the stock down about 20% at this point. Finally, I hope that a safe blood substitute can be developed at some point to address the needs you outlined, but I don't think PolyHeme is the answer.

    Dec 31, 2008. 11:48 AM | Likes Like |Link to Comment
  • New Scandinavian Nordic Region Index [View article]
    PowerShares (PWD) FTSE RAFI Europe Small-Mid Portfolio


    On Dec 18 09:25 AM aitvaras wrote:

    > Is there any ETF available which includes the Baltic states, especially
    > Latvia?
    Dec 18, 2008. 09:55 AM | Likes Like |Link to Comment
  • First-Ever Airlines ETF Set for Takeoff [View article]
    A Short ETF for the airlines may have been a better idea:

    On Dec 11 07:25 PM k9s-4-k8 wrote:

    > Talkin' bout an ETF that's prone to crash and burn!
    > Sorry I couldn't help myself.
    Dec 11, 2008. 08:51 PM | Likes Like |Link to Comment
  • Looking for Laggards After the Latest Market Rally [View article]
    Here is the rest of the article from my blog with a valuation comparison of HITK vs. CPD:

    With shares of HITK trading up today by about 25% on record quarterly revenue of $25.1M and diluted net income of $1.1M or 9 cents per share, Caraco appears extremely undervalued at current levels of $3.50 per share. Caraco trades at the lowest price to sales ratio [PSR] in the generic drug industry at just 0.24X with a trailing price to earnings ratio [PE] of less than 4X, zero debt, $33.6M cash, and a market cap of $123M. As a comparison HITK trades at a PSR of 0.84X with an estimated forward PE of 16X, negligible debt, $16.1M cash, and a market cap of $71M.
    Dec 9, 2008. 06:11 PM | Likes Like |Link to Comment
  • New Index of Pet and Animal Care Companies [View article]
    At least one expert in the ETF industry would disagree with you:

    Also, there are favorable growth trends in the animal & pet care industry and the potential for buyouts of the smaller companies by big pharma companies with animal health divisions such as SGP & PFE, but I am sure you know all of this based on the extensive research required for such a comment -- "is it just me or does this seem a bit ridiculous" --

    Domestically, pet spending for 2008 is estimated to be about $43.4 billion, up from $23 billion in 1998.

    The worldwide market for animal healthcare, excluding bulk feed and nutrition products, is expected to reach just under $20 billion in 2008, experiencing growth of 26% from a level of $15.6 billion in 2003.
    Dec 6, 2008. 09:45 AM | Likes Like |Link to Comment
  • Lumber Prices YTD vs. Timber ETFs [View article]
    Here is a link to 3 recent articles comparing the global price of coal futures to the 2 coal ETFs (KOL + PKOL) and other energy commodity funds:

    On Nov 25 12:54 PM sbenard wrote:

    > I had been wondering how closely correlated the futures would be
    > to the ETFs. Thanks for the info! I've noticed that commodity futures
    > also tend to be somewhat less correlated to commodity stocks, following
    > this same pattern.
    Nov 25, 2008. 02:42 PM | Likes Like |Link to Comment
  • 73 Decision Dates on Updated FDA Calendar [View article]
    But since those examples are history --> Look for major upcoming decisions for small/mid-caps CYPB, PTIE, KG, ALO to name a few that will have major stock price impact

    On Nov 24 05:23 AM mikehav wrote:

    > How about 50% gain or LGND, 103% gain for AMAG, 80% decline for TARG
    > witihin the last few weeks based on either approval decisions or
    > panel recommendations
    Nov 24, 2008. 05:31 AM | Likes Like |Link to Comment
  • 73 Decision Dates on Updated FDA Calendar [View article]
    How about 50% gain or LGND, 103% gain for AMAG, 80% decline for TARG witihin the last few weeks based on either approval decisions or panel recommendations

    On Nov 23 09:59 AM BlueOkie wrote:

    > Nice to know information but not sure how it relates to investment
    > decisions. Unless a new drug will cause a big move in stock price,
    > it has only small value.
    Nov 24, 2008. 05:23 AM | Likes Like |Link to Comment
  • New Emerging Biotech and Pharma Company Index [View article]
    Below is link to my original blog post where you can click on the image to enlarge or download:
    Nov 23, 2008. 10:17 AM | Likes Like |Link to Comment
  • Defensive Dividend Stocks Offering Value Now, And Comparative ETFs [View article]
    Try the original post at my blog - click on the image to enlarge and it is easy to view or download:

    On Nov 19 08:28 AM anonNH wrote:

    > chart is lo res & unreadable....
    Nov 19, 2008. 09:05 AM | Likes Like |Link to Comment
  • 10 Micro and Small Cap Healthcare Value Stocks Currently Under the Radar [View article]
    Here is the other part of the article (ex-healthcare):
    Industrials – Textile Manufacturing: Culp (CFI) trades at some of the deepest valuations of all the companies listed with a PSR of 0.15X, PE of 7X, and a PBR of 0.4X and I wrote about it recently as a turnaround candidate on cost cutting and debt reduction despite its exposure to the highly competitive furniture and bedding markets as a manufacturer of upholstery and mattress fabrics in the face of housing and economic downturn.

    Industrials – Security Products/Services: Napco Security Systems (NSSC) has lost over two-thirds of its market value in the past year as a provider of electronic security products that has been affected by the housing and economic slowdown. However, Napco has been in the business for over 30 years and the Founder & CEO, Dick Soloway, owns about 6M of thhe19M shares of outstanding common stock.

    The Company is conservatively managed with a history of accretive acquisitions and has the ability to navigate through tough economic conditions. Also, a commitment of over 5% of revenue to R&D for the development of innovative products positions the Company well for enhanced profits once th economy and housing markets rebound. Click here for my September 2007 article on Napco and some peer valuations, including 2001 acquisitions by Tyco (TYC) at about 2X sales for Sensormatic and SecurityLink – a full 4X greater than Napco's 0.5X PSR.

    Industrials – Infrastructure: L.B. Foster (FSTR) is a manufacturer of products for the railroad, construction, energy and utility markets which is poised to gain on prospects for increased spending by the government to improve our nation's infrastructure.

    Alternative Energy – Solar: Canadian Solar (CSIQ) has traded down sharply on lowered estimates and analyst downgrades, which appear to be piling on the stock at or near the bottom as it has cratered from all-time highs of around 50 bucks to a low of 5 bucks this week.

    Technology – Alvarion (ALVR) provides WiMAX and other wireless broadband connectivity systems worldwide which trades at an EV of just $55M despite being profitable with excellent growth prospects. CIBER (CBR) is an IT services company trading at 1995 levels on lower profit and sales guidance for 2008.
    Nov 16, 2008. 05:09 AM | Likes Like |Link to Comment
  • Updated FDA Decision Date Calendar [View article]
    No FDA sites or free websites that I know of - that is why I maintain the list at my blog and post here at Seeking Alpha with updates:
    Nov 14, 2008. 08:59 AM | Likes Like |Link to Comment
  • Winning ETFs under Obama [View article]
    Not enough established stem cell companies with large enough market caps for a pure-play ETF, but included stem cell + regenerative medicine companies such as Osiris (OSIR), Geron (GERN), Cytori (CYTX), and others in this new index:
    Nov 13, 2008. 08:54 PM | Likes Like |Link to Comment
  • Bullish Outlook for Preventive Medicine Companies Reflected in New ETF [View article]
    Yes, the article is to highlight a new index featuring diagnostic + diabetes care companies as the major components - this is the title I used on my blog:

    Obama-Care Focused on Preventive Medicine

    On Nov 06 10:42 AM Yossel wrote:

    > Re SteveTN: It appears the article was written to alert us to a new
    > index, while a headline writer wrote an erroneus slug about a new
    > etf.
    Nov 6, 2008. 11:05 AM | Likes Like |Link to Comment
  • Yahoo: Set for an Up $7, Down $2 Trade [View article]
    Thursday November 6, 7:49 am ET

    NEW YORK (Reuters) - Shares of Yahoo Inc (NasdaqGS:YHOO - News) rose 5.7 percent to $14.72 before the bell on Thursday after the company's CEO said a deal with Microsoft (NasdaqGS:MSFT - News) remained its best option.

    On Nov 01 06:33 PM grishick wrote:

    > Seriously, give it up already... wasn't it made clear by Yahoo! management
    > that they do not want to get acquired? What reason do they have to
    > sell now? Smart ppl sell at high and buy at low, not the other way
    > around. For Yahoo! to sell now would be really unsmart. If you long
    > YHOO - stop watching the ticker, because in recession it is not going
    > to be pleasant no matter, what you long. Check back in a couple of
    > years.
    Nov 6, 2008. 07:57 AM | Likes Like |Link to Comment