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Trading FDA, Clinical Trial Binary Events: $ANDS $BNVI $AMRN $EXAS

By Mike Havrilla on 07/29/2010 – 5:10 am PDTLeave a Comment

Below are some Regulatory Catalyst Index updates for companies with recent FDA and clinical trial related news…

Anadys Pharma (NASDAQ:ANDS) announced that six patients (100%) receiving 200mg twice daily of ANA598 (a direct-acting anti-viral agent against hepatitis C virus or HCV) maintained undetectable levels of HCV at 12-weeks post-treatment (Sustained Virological Response 12 or SVR12). Additional post-treatment results from other treatment arms in the ongoing Phase 2 study are expected later this year.

Bionovo (NASDAQ:BNVI) announced today that it received final guidance from the European Medicines Agency (EMA) for conducting a pivotal Phase 3 study of MENERBA for menopausal symptoms. In addition, BNVI has conducted a meeting with the FDA for the US development plan and will provide more details when the minutes from this meeting are released.

Below are summaries of the most recent articles written by Mark Messier at - please visit the site to read the full articles, in addition to many other free tools and strategies related to binary event investing…

Amarin Corp. (NASDAQ:AMRN) — Clinical Trial with Upcoming Catalysts

Posted: 29 Jul 2010 02:38 AM PDT

I respect Mike Havrilla as a person, pharmacist, and trader, so when I found out that he expressed much confidence in a clinical trial, I wanted to learn more.  I am passing this information on to my subscribers. I currently have no position in AMRN, but I am looking to open one after the October Run-Ups. For [...]

EXACT Sciences (NASDAQ:EXAS) Updates - Detection Technology Achieves 100% Sensitivity

Posted: 28 Jul 2010 07:38 AM PDT

This post is to update you on some recent developments and research done on EXAS.  Clink on the title to read the article we published on Monday: “EXAS- Data Validation Study with a 10/29/10 Catalyst Date”. Today, July 28th Exact Sciences reported their Q2 earnings.  Some of the highlights include: Financial Information Exact reported total [...]

Below is a summary of my recent real-time trading updates posted yesterday on the Forum…

With the run-up in EXAS shares over past few days, none of my orders got filled so I decided to buy back into AMRN today with a little less money on the table (withdrew approx. $27K for non stock related investments)…I expect some cash to free up ahead of 29-Oct results for EXAS and may take a position on any pullbacks or just pile into AMRN over the next few months…

AMR101 (Ethyl-icosopentate or Ethyl-EPA) (Prescription-Grade Omega-3 Fatty Acid) — Pivotal Phase 3 MARINE (NCT01047683), ANCHOR (NCT01047501) Clinical Trials under SPA ( IDs) (6-8 week run-in periods prior to the12-week treatment periods). AMRN is fully funded through a potential NDA filing with ongoing partner talks. My estimate for MARINE study to be fully randomized is 3Q10 (early AUG) and to complete the study by end OCT for potential results by year-end 2010 in DEC or early 2011. My estimate for the ANCHOR study to be fully randomized is during 4Q10 with potential results during 1-2Q11. is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and pending binary events such as FDA decisions and clinical trials. The HavRx Regulatory Catalyst Index update report is currently tracking 617 entries and 428 companies (with approximately 200 stocks trading under $5 per share and 78 private companies). Click here for a subscriber overview article that includes an email archive web link for a 50% discount ($150) promo code off the regular one-year, non-recurring subscription price.

Disclosure: Long AMRN

Related Articles:

  1. Trading FDA, Clinical Trial Binary Events: $ATHX $AZN $VRTX $MKGAY
  2. Trading FDA, Clinical Trial Binary Events: $MNKD $AXN $GERN
  3. Trading FDA, Clinical Trial Binary Events with Revised Bio Run-Up Strategy: $AMRN $CADX $EXAS
  4. Trading FDA, Clinical Trial Binary Events: Why Amarin (NASDAQ:AMRN) is My Top Buy
  5. Trading FDA, Clinical Trial Binary Events: $AMRN $CXSPY $AZN

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