• ADMA Biologics (ADMA) PDUFA of RI-002 for Infection Prevention in Primary Immunodeficiency Disease

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    Biotech Forecast
    Clinical and Regulatory
    Event Type: PDUFA
    Timing: H2 2016
    Designation(s): None

    This event is set for a broad date range and therefore the exact timing is unknown. This adds a degree of risk.
    FDA special designations may increase the likelihood of success and decrease the time to approval.
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    Disease and Treatment
    Disease: Autoimmune
    Indication: Infection Prevention in Primary Immunodeficiency Disease
    Lead Indication?: Yes
    Treatment Name: RI-002

    Likelihood of event success varies depending on disease, treatment and lead indication classification.
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    Company Information
    Co. Name: ADMA Biologics
    Stock Symbol: ADMA
    Shares Traded: NASDAQ

    The OTC BB and OTC Markets have less stringent reporting and financial requirements than the NASDAQ and NYSE. This may increase the level of risk for investors. Smaller size may have an influence on likelihood of success.
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    Event Status
    Event Outcome: Ongoing
    Event Discussion: Forums
    Event Announcement(s): http://www.admabiologics.com/media-center/company-news?detail=379
    http://seekingalpha.com/article/3740456-adma-biologics-inc-year-review-year-ahead
    Partnership: Yes

    Partnerships help smaller biotech companies finance the long approval process. Partnership also provides validation the clinical program may be a worthy investment.
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    Detailed Event Description from Company Announcement

    Quote

    As we continue to transition into a commercial company, with anticipated FDA approval of RI-002 during the second half of 2016, we hired key commercial staff members, procured additional raw material inventory for the future commercial production of RI-002 and continued marketing and reimbursement pre-launch activities.

     


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