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Discovery Laboratories Inc. Message Board

  • megapickq megapickq Sep 13, 2013 1:49 PM Flag

    CXM (MC $5 M) FDA approval in 2 Months + Shares Out 7 M = 5++ BAGGER

    CXM has 1 Drug approved another 1 in Phase 3 which has huge Market Potential .

    Cardium (CXM)

    Market Cap : $5.03 M
    Cash $3 M
    Price : $0.70

    Shares Out : 7.3 M

    Cardium Announces New Excellagen FDA 510(k) Submission Based On Expanded Structural And Functional Properties....Mon, Aug 5, 2013 9:00 AM EDT
    --

    510(k) Approval Process

    FDA will review your submission within 90 days

    The FDA has a goal of reviewing submissions within 90 days, but that timeline can vary by product. On average, it takes about 135 days from the time you submit your 510(k) to the FDA for review, until it is cleared by the FDA. The FDA charges a fee to review your submission. If successful, you will receive a 510(k) clearance letter from FDA with your 510(k) number.
    --
    "Generx® Global Cardiovascular Platform: International cost-efficient “ASPIRE” Phase 3 /
    Registration Study underway │ Study Design: 100 patients with SPECT imaging efficacy endpoint
    │ Initial medical condition: Cardiac Microvascular Insufficiency (CMI) for patients with myocardial
    ischemia with symptomatic chronic stable angina due to coronary artery disease │ Favorable
    manufacturing (≥ 90% gross margin) │ 100k to 200k annual treatments  $200 - $400 million
    revenue"
    -

 
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