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Mike Havrilla  

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  • 5 Near-Term, Low-Priced Bio-Catalyst Trades [View article]
    yeah the 510k clearance came quickly this time compared to the first drawn-out attempt! Looking at 1Q12 results, seems NEPH is closing in on break-even/profitable results w/ one remaining milestone pmt from Bellco and potential for more extensive military orders...valuation seems a bit high at over 10X sales but such an early stage that anything could happen from here
    Jun 14, 2012. 01:25 PM | 1 Like Like |Link to Comment
  • 5 Near-Term, Low-Priced Bio-Catalyst Trades [View article]
    Glaxo would be natural fit assuming AMR101 gets the extended patent protection...would be a nice follow-on product to lovaza before generic competition in a few years...Pfizer would also make sense given that Lipitor went generic...I think somewhere in high teens to low twenties for fully diluted valuation around $3 billion makes sense assuming peak sales around $1 billion for AMR101 similar to Lovaza (which likely benefits from extensive off-label use by prescribers)
    Jun 14, 2012. 01:19 PM | Likes Like |Link to Comment
  • 5 Near-Term, Low-Priced Bio-Catalyst Trades [View article]
    yeah that ship sailed long ago! I will venture to say that I have no control over ARNA share price at this point w/ the stock trading 10's millions in volume daily and I have no plans to trade it long or short
    Jun 14, 2012. 01:17 PM | Likes Like |Link to Comment
  • A Primer on Pacira Pharma [View article]
    Yes, PCRX plans to conduct addt'l studies to support use of EXPAREL for nerve blocks and epidural administration--they are hoping to get premium pricing for the long-acting (72 hours) feature compared to standard formulations of bupivacaine
    Apr 27, 2011. 09:45 AM | Likes Like |Link to Comment
  • Regulatory Catalyst News for ALKS, AMLN, LLY, MNKD, SVNT [View article]
    check out my new publishing business and website at mikehavRx.com
    May 23, 2010. 09:36 AM | Likes Like |Link to Comment
  • This Is Worth Your Attention. Please Read It. [View instapost]
    Justin is an excellent writer and investor, with a focus on options and stocks of innovative growth companies in the clean-tech and bio-medical space. His new website and service at RxInvestors.com is an excellent value and resources for investors.
    Mar 18, 2010. 08:31 AM | Likes Like |Link to Comment
  • Unilife: Medical Device Innovator Creating Jobs In Pennsylvania [View article]
    NEH, The major investment and agreement with Sanofi (SNY) may give you some confidence, along with the manufacturing facility in Central PA.

    Mike


    On Nov 01 12:07 PM NEH wrote:

    > I love it Mike - it's exactly the kind of under-the-radar investment
    > I look for. Sadly, the manufacturing partner is in China, and I don't
    > trust anything manufactured in China these days.
    Nov 1, 2009. 12:38 PM | Likes Like |Link to Comment
  • Celldex Therapeutics: Plenty of Cash, Pending Clinical Catalysts [View article]
    Hope8610, As I posted in the previous comment, I believe the science will ultimately make CLDX a winner, but the downturn in the stock price has been unrelenting thus far. IMUC also turned down today despite impressive Phase 1 survival data for its cancer stem cell vaccine ICT-107.

    Mike


    On Oct 27 03:16 PM Hope8610 wrote:

    > I bought 4000 CLDX at $8.80. will it keep going down? should I hold
    > it or sell it? what
    Oct 27, 2009. 10:00 PM | Likes Like |Link to Comment
  • Celldex Therapeutics: Plenty of Cash, Pending Clinical Catalysts [View article]
    Thanks, retiredpharma -- I believe the science will ultimately make CLDX a winner, but the downturn in the stock price has been unrelenting thus far.

    Mike


    On Oct 24 12:02 PM retiredpharma wrote:

    > Mike,
    >
    > I read you often and I am a bio-pharma investor! Bought Avant before
    > the CLDX merger about 13 and sold all into the August 2008 run-up
    > at 17-18! Got back in a bit early but average cost of shares is about
    > 7 even w/ this bad recent downturn.
    >
    > I believe in the science of CLDX but like many I am questioning the
    > silence from management. Not sure if this is a legal thing w/ the
    > CRGN merger but now that the merger is behind us it seems to persist!
    >
    >
    > I want to double down now and probably will no matter but would like
    > your thoughts on this Transparency Issue...real or imagined?
    >
    > retiredpharma
    Oct 27, 2009. 09:58 PM | Likes Like |Link to Comment
  • BioMed News: Antigenics, Shire, King Pharma, Delcath Systems [View article]
    here is the actual strategy. . . provide subscribers with info on pending biomed catalysts in a calendar format, provide some examples / strategies for how to use the info in the calendar (e.g. Extreme Trading articles, including 85 single digit stocks in my most recent update), and price the service economically so retail investors can affort to subscribe.


    On Oct 23 10:53 AM hoopdreamerz@yahoo.com wrote:

    > here's havrilla's strategy:
    > * Buy before the news
    > * pump it up with biomedreports and press releases
    > * sell before the news.
    >
    > What a shameless scammer you are!
    >
    > <<<I recommend a strategy (outlined in the extreme trade articles)
    > of investing in a basket of small / micro-cap biomed stocks with
    > pending catalysts well ahead of their binary events and selling before
    > the event occurs.>>
    Oct 23, 2009. 02:24 PM | 1 Like Like |Link to Comment
  • BioMed News: Antigenics, Shire, King Pharma, Delcath Systems [View article]
    Bam, Was having technical / IT issues with Google's blogger service so I have redirected mikehavrx.com to the ProActiveNewsRoom.com site, which already has a blog, my stock indexes, etc.

    Mike


    On Oct 22 10:43 PM BambamPoop wrote:

    > Mike,
    >
    > What happened to your site? mikehavrx.com ? discontinued? or just
    > temporarily down?
    >
    > bambampoop
    Oct 23, 2009. 02:18 PM | Likes Like |Link to Comment
  • NF Energy: Continuing Its Robust Growth [View article]
    dual cit, thanks for the heads up on Starpharma and I will take a closer look. I have been following Unilife Medical (UNIFF.PK) since early this year and the stock is doing well -- the Company is also relocating near me in Central PA from Australia.

    Mike

    On Oct 22 08:56 PM dual cit wrote:

    > Mike, perhaps you can begin to follow some of the more exciting biopharma
    > companies coming out of Australia. For example, Starphama (ADR: seekingalpha.com/symbo...).
    > I believe your followers would benefit greatly from your knowledge
    > here.
    >
    > Disclosure: We are one of the original VC's of this company and are
    > long.
    Oct 23, 2009. 02:16 PM | Likes Like |Link to Comment
  • BioMed News: Antigenics, Shire, King Pharma, Delcath Systems [View article]
    Fer,

    INSPIRE reflects the name of the patient registry that was launched in 2007 to confirm the survival trends and to continue collecting overall survival data observed from the Phase 3 kidney cancer study, providing an additional 3 years of data since the trial was closed. The Phase 3 trial is over, and the update next year is for the patient registry.

    Recurrence events in patients with stage I or II disease were reported in 19 (15.2%) patients in the Oncophage group and 31 (27.0%) in the observation group, which represents a patient subset with early stage disease.

    On Oct 22 02:26 PM User 476730 wrote:

    > Mike,
    > I'd like to insist if you could clarify in words that only a shmuck
    > could understand. I'm confused in regards to the kidney cancer study.
    >
    >
    > So far I believe there are some contradictions:
    >
    > Study ongoing:
    > 1. From AGEN website / PRs it seems that the Phase 3 non-metastatic
    > kidney cancer study is still ongoing with final results from INSPIRE
    > expected mid-2010.
    > Was INSPIRE the Phase III study?
    >
    > Study failed:
    > 1. "... the reason for no US approval and the negative opinion for
    > EU approval announced today for Oncophage (aka vitespen) lies in
    > the fact that the clinical trials did not achieve their prospective
    > (i.e. before the trial started) primary outcomes in the pivotal Phase
    > 3 trials that I have referenced below in melanoma and kidney cancer."
    >
    > 2. kidney cancer trial: Lancet. 2008 Jul 12;372(9633):145-54. Epub
    > 2008 Jul 3.
    > No difference in recurrence-free survival was seen between patients
    > given vitespen and those who received no treatment after nephrectomy
    > for renal cell carcinoma.
    >
    >
    > Does the following mean the study was not tested in patients with
    > early stage disease?:
    > "A possible improvement in recurrence-free survival in patients with
    > early stage disease who received vitespen will require further validation."
    >
    >
    >
    > What exactly does this mean?:
    > "Positive data” from the trials was only generated after the fact
    > by analyzing the data (data mining) to identify subsets of the patient
    > population which may have benefitted from treatment in the study.
    >
    >
    >
    > Bottom line, is phase III for kidney cancer failed and buried or
    > still ongoing with final results (from INSPIRE?) expected mid-2010?
    >
    >
    > Thanks again.
    > Fer
    Oct 22, 2009. 02:44 PM | 2 Likes Like |Link to Comment
  • BioMed News: Antigenics, Shire, King Pharma, Delcath Systems [View article]
    dreamdivers, your comments are laughable and misdirected, have you reviewed the article history for AGEN?

    seekingalpha.com/symbo...

    You don't seem to understand the difference between recommending a stock and providing info about biomed stocks with pending catalysts in a calendar database for subscribers to research further and make their own decisions.

    Not to mention the fact that I recommend a strategy (outlined in the extreme trade articles) of investing in a basket of small / micro-cap biomed stocks with pending catalysts well ahead of their binary events and selling before the event occurs.


    On Oct 22 01:34 PM dreamdivers wrote:

    > I think it's almost laughable that Havrilla is now leaving comments
    > on Feuerstein's TSCM article trying to "explain" how the EMEA managed
    > to reject Oncophage, despite the wonderful data mining results.
    Oct 22, 2009. 02:24 PM | 2 Likes Like |Link to Comment
  • BioMed News: Antigenics, Shire, King Pharma, Delcath Systems [View article]
    dreamdivers, you can review my article archives and easily distinguish between information provided on upcoming data points, regulatory decisions, and clinical catalysts as compared to stocks that I own or write commentaries on.

    AGEN is tracked in the FDA Calendar database because it will release an update next year from the patient registry which will impact the stock price. I have never written an opinion piece on AGEN or recommended that anyone buy the stock and have only pointed it out for the pending catalysts in the form of the EMEA decision and clinical data update.

    On Oct 21 09:17 PM dreamdivers wrote:

    > So in your article today you devote an entire first paragraph to
    > summarizing the "positive" data, which you later admit comes only
    > from the company data mining retrospectively? Meanwhile, you reluctantly
    > admit only when directly questioned that pivotal trials in both RCC
    > and melanoma failed? You guys really should be ashamed, why not just
    > put on cheerleader skirts and make it official.
    Oct 21, 2009. 09:37 PM | 5 Likes Like |Link to Comment
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181 Comments
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