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Mike Havrilla

 
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  • Ventrus Bio Poised For Run-Up Into Second Round Of Phase III Results [View article]
    They have presented plans to contract a specialty GI sales force that would target gastro docs so while a partnership/buyout would be much better (Salix Pharma is big into GI drugs and recently acquired Santarus so that would be the best outcome since they are in the mid-cap range so would consider a niche product like this one compared to big pharma which would never be interested), I think they could market okay on their own given a targeted audience of GI docs that is already familiar w/ the drug (compounded diltiazem) with the advantage of having a potentially FDA approved, off-the-shelf option that could be covered by third-party payers.
    Nov 27, 2013. 10:17 AM | 2 Likes Like |Link to Comment
  • Venaxis: Well-Funded Ahead Of Multiple Catalysts Expected Through Year-End [View article]
    FYI on the chart/trade summary section; I wrote and submitted this article on Saturday
    Jul 29, 2013. 06:16 PM | Likes Like |Link to Comment
  • Merrimack Poised For Post-Offering Bounce Ahead Of Phase III Results [View article]
    There is no interim analysis planned for MM-398 as per update in the recent prospectus filing so next catalysts included completing enrollment this quarter w/ top-line data to follow 4Q13-1Q14...MM-398 is a novel, stable nanotherapeutic encapsulation, or enclosed sphere carrying an active drug, of the marketed chemotherapy drug irinotecan. MM-398 achieved its primary efficacy endpoints in two Phase 2 clinical trials, one in pancreatic cancer patients and one in gastric cancer patients. We are conducting a Phase 3 clinical trial of MM-398 in patients with metastatic pancreatic cancer whose cancer has progressed on treatment with the chemotherapy drug gemcitabine. We expect to complete enrollment in the third quarter of 2013 and to announce top line results during the fourth quarter of 2013 or the first quarter of 2014…

    My price estimates are not long-term in nature or derived from discounted cash flow analysis...they are short-term trading targets based on moving averages and typical small-cap bio stock price percentage reactions to binary events such as clinical trial results or FDA decisions.
    Jul 18, 2013. 09:23 AM | 1 Like Like |Link to Comment
  • Venaxis Poised For Run-Up Into Pivotal Study Results [View article]
    CT scan is the gold standard for diagnosis and to determine if surgery is required to remove the appendix so APPY1 test would fit in between to determine if the patient is low-risk for appendicitis so that CT scan/radiation exposure is not really necessary which is especially important in younger patients at higher risk to the radiation exposure
    May 1, 2013. 12:26 PM | 3 Likes Like |Link to Comment
  • Venaxis Poised For Run-Up Into Pivotal Study Results [View article]
    They expect to make initial shipments to distributors along w/ hospital marketing studies this quarter but no meaningful revenue is expected to begin until next year
    Apr 30, 2013. 08:55 AM | 1 Like Like |Link to Comment
  • Nymox Pharma: Developing A Potential Long-Term Treatment For BPH [View article]
    forgot to embed the six-month stock chart...
    http://bit.ly/11nH9zK
    Apr 3, 2013. 04:51 PM | Likes Like |Link to Comment
  • Anika Therapeutics: Growth Stock At Value Prices With Near-Term FDA Catalyst [View article]
    tax loss selling is possible but with stock stabilizing in mid-$10s and expected near-term FDA decision for Monovisc plus expected record 4Q revenue early next year I think stock has great upside potential into year-end and through early next year.
    Nov 26, 2012. 03:24 PM | Likes Like |Link to Comment
  • Amicus Therapeutics Poised For Rebound Into December Phase III Results [View article]
    I guess we will find out next month and there is always risk of failure in P3 trials but I don't see how either company would be hiding anything since results remained blinded to both companies...also with the timeline for the P3 results next month there is an opportunity to trade the stock for a rebound/run-up into the results as it is trading well below the 50/200-day moving averages and had a strong run-up about a month ago to mid-$6s
    Nov 8, 2012. 02:16 PM | Likes Like |Link to Comment
  • Amicus Therapeutics Poised For Rebound Into December Phase III Results [View article]
    below is what FOLD announced w/ 2Q12 results & during 3Q12 results announced the six-month primary endpoint data is due next month so what data is not being released?

    2Q12 results> http://bit.ly/SKBUrQ

    "Amicus and GSK have recently engaged in encouraging interactions with the FDA regarding the planned NDA for migalastat HCl. The agency indicated it would consider safety and efficacy data from both the six- and 12-month kidney biopsies to support conditional approval under subpart H. In order to preserve the integrity and availability of clinical data for the open-label follow-up period, Amicus and GSK have jointly determined that the unblinding and analysis of the data from the primary six-month treatment arm will not occur prior to the fourth quarter 2012. Both companies remain blinded to the results at this time."

    3Q12 results> http://bit.ly/RHJbXk

    During the fourth quarter 2012, Amicus and GSK expect to announce the primary endpoint analysis, based on interstitial capillary globotriaosylceramide (GL-3) as measured in kidney biopsy at 6 months. Results from the 6-month follow-up period in Study 011 are expected in the first half of 2013, which will include 12 months on migalastat HCl in the treatment group and 6 months on migalastat HCl in the placebo-crossover group.
    Nov 8, 2012. 01:04 PM | 1 Like Like |Link to Comment
  • Amicus Therapeutics: Rare Disease Drug Developer Expected To Reveal Phase III Results In 3Q12 [View article]
    I am hoping they give some kind of guidance to report the P3 results...would make it a great run-up trade...otherwise results could be out at any time...I ended up closing my position today with the stock in the red on big up market day and going into the weekend so will watch until their quarterly results/update
    Aug 3, 2012. 02:21 PM | Likes Like |Link to Comment
  • Amicus Therapeutics: Rare Disease Drug Developer Expected To Reveal Phase III Results In 3Q12 [View article]
    thanks, I bought a small position yesterday...may just let it ride thru results unless stock makes a big run before they are out
    Aug 3, 2012. 08:24 AM | Likes Like |Link to Comment
  • Amicus Therapeutics: Rare Disease Drug Developer Expected To Reveal Phase III Results In 3Q12 [View article]
    1) original agmt OCT 2010 $GSK purchased 6.9M shares @$4.56 which was 19.9% stake at the time

    2.) $FOLD sold 11.5M shares @$5.70 in MAR 2012 which diluted $GSK's original stake

    3.) expanded agmt w/ $GSK in JUL 2012 includes addt'l purchase of 2.9M shares @$6.30 bringing Glaxo ownership stake back to 19.9% w/ total ownership of 9.8M shares of $FOLD stock
    Jul 27, 2012. 06:26 PM | Likes Like |Link to Comment
  • 5 Near-Term, Low-Priced Bio-Catalyst Trades [View article]
    is very tough to catch a falling knife and pick exact bottom...my guess is the stock drifts lower after the failed P3 trial and planned start of second P3 trial for diltiazem not expected until 4Q12...recent big gainers in biotech with near-term late-stage clinical and/or FDA catalysts...also iferanserin was main value driver for stock since diltiazem cream available from compounding pharmacies and there is already approved drug RECTIV for same indication
    Jun 25, 2012. 08:08 PM | Likes Like |Link to Comment
  • Neptune Reports Strong Sales Growth Ahead Of Phase II Results [View article]
    Amarin was developing AMR101 for other neurological indications in Phase 2 and discovered the triglyceride lowering effect indirectly in these trials and was able to proceed directly to the Phase 3 trials due to a well established safety profile and known mode of action for omega-3s to lower triglycerides. After the failed Phase 2 neuro studies, Amarin did recapitalization to support the Phase 3 trials which ended up being highly successful.
    Jun 21, 2012. 02:34 PM | 1 Like Like |Link to Comment
  • Neptune Reports Strong Sales Growth Ahead Of Phase II Results [View article]
    The fact that Lovaza generates about $1 billion in annual global sales clearly validates the major sales potential for more potent prescription-grade omega-3 products since omega-3 supplements have been widely available for years so NEPT is basically trying to do the same thing with krill oil and hopes to generate Phase 2 data during 2H12 to show improved results compared to regular omega-3s based on the unique features of NKO such as the phospholipid make-up and antioxidant properties. It is true Phase 3 results are a long way off but their nutraceutical biz is growing and profitable (see news today on $25 million order) on standalone basis and majority subsidiary Acasti is the R&D branch.
    Jun 21, 2012. 01:05 PM | Likes Like |Link to Comment
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