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Taxus Cardium Pharmaceuticals Group, Inc. Message Board

  • biorunup@att.net biorunup May 18, 2010 2:03 AM Flag

    Listen! June 3rd is just an ESTIMATE

     

    The FDA does not set the expected "6 month 510K" approval times... that is the AVERAGE determined by investors. Please do not be fooled into an expecting a decision on, or even around that date.

    Article from my website at BioRunUp

    CXM- FDA 510k Run-Up ~ 6/3/10
    May 11th, 2010 by BioRunUp

    Cardium Therapeutics

    I have recently open a position in CXM for a month long play (10K @ $.516). Allow me to explain why.

    On December 3rd, 2009 CXM announced that its wholly-owned subsidiary, Tissue Repair Company, submitted a 510(k) premarket notification filing with the U.S. Food and Drug Administration (FDA) seeking marketing clearance of its Excellagen product candidate based on positive data from the Company’s recently completed Phase 2b Matrix clinical study.

    When the positive initial results of the Phase 2b trial were released the stock price had risen to nearly $2 before it fell victim to the “Sell on the News” mentality. Since that time CXM has fallen to a low of $.43. The 510k application was filed on December 3rd, and although there is no set time frame estimates for medical device approvals, a 6 month ROUGH estimate is usually assigned to these applications. Remember though, the FDA does not give a 6 month estimate, that is just the generally accepted consensus of BioTech. Approvals rarely come early (CAMH), and most are late. Some are VERY late, waiting 1 year or more.

    For this reason, I rarely hold a 510k play past its estimated 6 month approval date. There are many, many, many traders that do not understand the 6 month estimate, they feel that it is more concrete, like a PDUFA drug date. Because of this, we usually see a rise in the share price as this estimated date approaches, and a fall in price once estimated date passes and short term investors lose interest and move on.

    CXM has also experienced some erratic movement over the past few weeks, hitting $.70 on April 26th.

    This being said, I have taken a position in CXM, which I will close before the estimated 6/3/10 approval date. The plan is to then move the funds into more long term October FDA plays.

    Enjoy.

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