Trading FDA, Clinical Trial Binary Events: $ATRC $BIOD $CTIC

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

AtriCure (NASDAQ:ATRC) expects to file the final clinical module with the FDA for a Pre-Market Approval (PMA) submission during 1Q11 to support marketing clearance for its Isolator Synergy Bipolar Ablation System to re-establish normal heart rhythm in patients with atrial fibrillation (AF or a fib) based on the pivotal ABLATE clinical trial.

Cell Therapeutics (NASDAQ:CTIC) announced that it filed for a Special Protocol Assessment (SPA) agreement with the FDA for a new pivotal study in patients that failed first to third-line treatment and are not transplant eligible with relapsed or refractory aggressive B-Cell non-Hodgkin’s lymphoma (NHL). CTIC expects to begin the pivotal study pending FDA feedback by year-end 2010 along with filing for European regulatory approval this year.

Below are summaries of the most recent articles written by Mark Messier at www.BioRunUp.com — please visit his website to read the full articles, in addition to many other free tools and strategies related to binary event investing and trading…

Biodel (NASDAQ:BIOD) – 10/30/10 PDUFA for Diabetes Drug Heating Up

BIOD is another upcoming FDA play.  It has a PDUFA date set for October 30th, 2010 for its diabetes drug VIAject.   Let’s take a look at Biodel, and its leading drug- VIAject.  It looks to be an excellent candidate for trading using the Run-Up method. Biodel is taking advantage of what the FDA calls [...]

Vote for Your 3 Favorite Run-Up Candidates

If you had $100K to use strictly for run-ups, in which 3 companies would you purchase shares?

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 and personalized VIP services while the secure checkout page includes currently offered discount promo codes at https://mikehavrx.ssl.subhub.com/subscribe

Disclosure: No positions