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Northwest Bio gains key regulatory approval in Germany

Northwest Biotherapeutics (NWBO) gets a "Hospital Exemption" early access program for DCVax-L from German regulators. This means that the company may provide the product to patients for the treatment of Glioblastoma multforme and lower grades of gliomas outside of its clinical trial and charge full price.

The approval term is five years.

The German reimbursement authority approves DCVax-L eligibility for reimbursement from the Sickness Funds (health insurers). The specific level of payment will be negotiated by the company, hospitals and insurers.

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Comments (7)
  • JCS25
    , contributor
    Comment (1) | Send Message
    This is a significant development. Those who felt negative about the recent DSMB recommendation, can evaluate the German decisions and see if there are any negative angles to spin. I don't think so.
    10 Mar 2014, 09:18 AM Reply Like
  • slup
    , contributor
    Comment (1) | Send Message
    The Germans must know something no one else knows.
    10 Mar 2014, 09:53 AM Reply Like
  • mexec1
    , contributor
    Comments (69) | Send Message
    Does anyone know what the "full price" shall be or what the margins might be per unit?
    10 Mar 2014, 09:59 AM Reply Like
  • mexec1
    , contributor
    Comments (69) | Send Message
    I saw someone post on another article the cost would be $100k for a 3 year treatment? Knowing the margins on those sales would help us determine what a fair stock price range should be in the near term. Guessing the amount of patients to be treated will be trickier since anyone with this disease can fly to Deutschland and receive treatment. Also I wonder does NWBO manufacture their vaccine or outsource it to someone like NBS/PCT?
    10 Mar 2014, 12:07 PM Reply Like
  • InmanRoshi
    , contributor
    Comments (216) | Send Message
    In contrast, DCVax-L is the first product of its kind to receive Hospital Exemption approval from the German regulators, in the following key ways:


    -- the first immunotherapy;


    -- the first product which exerts pharmacological (i.e., drug-like) effects
    in the patient's body;


    -- the first product that has never previously been on the market


    -- the first product developed by a non-German company, not previously under
    the German regulators' oversight; and


    -- the first "somatic" cell therapy product (a somatic cell is any cell of
    the body other than a reproductive or embryonic cell).

    10 Mar 2014, 10:23 AM Reply Like
  • betternbtr
    , contributor
    Comment (1) | Send Message
    We know that the efficacy is excellent and we have been following this for over 3 yrs. Those who bash this raw data want to scoop more shares. BTW, we have been accumulating since .30c.
    10 Mar 2014, 11:35 AM Reply Like
  • bioinfo
    , contributor
    Comments (25) | Send Message
    its just a matter of time when FDA makes a similar move here. Of Course I believe we are yet to hear from DMC, dont think what we got last week was it on the interim review.
    10 Mar 2014, 07:15 PM Reply Like
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