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Trading FDA, Clinical Trial Binary Events: $DSCI $IRIS $VVUS

publication date: Jul 9, 2010
 | 
author/source: Mike Havrilla
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Below are some Regulatory Catalyst Index updates for companies with recent FDA and clinical trial related news...

Derma Sciences (NASDAQ:DSCI) ($4.97, $32.6 million market cap)

DSCI announced today that it submitted a FDA 510(k) earlier this month, seeking marketing clearance for a MEDIHONEY Wound Dressing line extension for a product that is dispensed from a tube containing Active Manuka (Leptospermum) Honey blended with gelling agents, in addition to a pending US patent application for the product.

Vivus (NASDAQ:VVUS) ($11.69, $945 million market cap)

QNEXA (phentermine plus topiramate) -- FDA Advisory Panel Meeting on 15-July with briefing documents scheduled to be posted on 12-July and an expected FDA decision by 10/28/10 under a standard 10-month review period, seeking FDA approval as a combination weight loss / obesity drug. Shares of VVUS have rallied sharply in the past few days, so investors may be looking to sell ahead of the briefing documents on Monday, which tend to spook the market and typically outline concerns over drugs to be reviewed - even if they are ultimately recommended for approval.

FDA Weekly Calendar Updates by Mark Messier at www.BioRunUp.com -- Make sure to check out and sign up for the new BioRunUp.com users forum at www.BioRunUp.com/forum (more info coming out on Monday)

IRIS International (NASDAQ:IRIS) ($9.95, $182 million market cap)

FDA 510(k) submission for Urinalysis Machine. ESTIMATED date of 12/31/10

www.mikehavRx.com 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 actively managed HavRx Regulatory Catalyst Index update report is currently tracking 598 entries and 400 companies (including approximately 200 stocks trading under $5 per share and 59 private companies). Subscribers also have access to my real money portfolio tracker, Google Calendar event tracking for over 1,000 stocks in the HavRx Indexes, and real-time trading / article updates on the member forum. Click on the following email archive web link for a 50% discount promo code... http://eepurl.com/FWdn

Disclosure: No positions

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www.mikehavRx.com is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and binary event tracking for FDA decisions and clinical trials, including 600+ events and 400+ companies with approximately 200 stocks trading under $5 per share and 80+ private companies. The home page includes an overview of the binary event tracking service and the secure checkout page includes currently offered discount promo codes at https://mikehavrx.ssl.subhub.com/subscribe