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ONYX Pharmaceuticals, Inc. Message Board

  • ftgc3 ftgc3 Aug 2, 2000 1:09 AM Flag

    NOTHING EVEN CLOSE TO 4 YEARS

    NOTHING EVEN CLOSE TO 4 YEARS
    The Clinical
    Trial Process ( 4 )

    Phase 1
    Phase 1 trials
    concentrate on developing the drug's safety profile. The
    human subjects in the study are normally healthy
    volunteers, though sometimes patients who have terminal
    illnesses and have no other therapeutic alternative will
    take part in Phase 1 studies as well. The sample is
    normally not more than 100 patients in Phase 1. The basic
    goal of Phase 1 is to determine how the drug is
    absorbed, distributed in the body, metabolized, and
    excreted. The duration of the drug's effects are also
    measured. Phase 1 testing ranges from one to three years,
    on average.

    Assuming the data from Phase 1
    are positive and the safety of the compound is
    established, the drug moves on to Phase 2 testing. If the
    company moves on to begin Phase 2 trials, the drug's
    chance of eventually making it to market improves to
    just under 30%.

    Phase 2
    Phase 2 trials
    consist of small, well-controlled experiments to continue
    to evaluate the drug's safety and assess side
    effects. The drugs are given to volunteers (usually
    between 100 and 300 patients) who actually suffer from
    the disease or condition being targeted by the drug.
    This phase is where the optimal dosage of the drug is
    established. Also, statistical end points are established for
    the drug that represent the targeted favorable
    outcome of the study. The current standard of care for
    the medical condition can be used as a benchmark in
    setting the end point. Phase 2 trials last an average of
    two years.

    A drug that moves on to begin Phase
    3 testing has about a 60% chance of actually being
    approved by the FDA.

    Phase 3
    Phase 3 testing is
    intended to verify the effectiveness of the drug against
    the condition that it targets, based on the
    statistical end points established in Phase 2. The study also
    continues to build the safety profile of the drug and
    record possible side effects and adverse reactions
    resulting from long-term use. Phase 3 studies are tightly
    controlled, double-blind studies with a sample size of at
    least 1000 patients. If the drug proves to be effective
    in this stage, the trial is deemed successful
    (pivotal). Normally two pivotal trials are required to
    ensure the validity of the studies, although if the
    results are extremely strong, one may suffice. Phase 3
    testing averages between three and four
    years.

    Assuming the drug reaches the desirable end point in Phase
    3 trials, the company will then file a New Drug
    Application, which can contain 100,000 pages of data
    supporting the efficacy and safety of the drug. At this
    point, the drug has better than a 70% chance of being
    approved by the FDA.

    Approval of the NDA can take
    anywhere from two months to an extreme of several years
    (in the case that the FDA requests additional
    information), with an average wait of between 18 and 24 months.
    Upon approval, the company may begin to market and
    distribute the drug.

    Phase 4
    Once the drug is on
    the market, the company must continue to perform
    observational studies in an ongoing evaluation of the drug's
    safety during routine use. The company also attempts to
    monitor any usage of the drug for conditions other than
    the approved medical indication. If the drug is being
    successfully used for off-label indications, the company will
    often initiate further clinical trials for those
    indications in order to widen the potential market for the
    drug. The company cannot advertise or endorse
    off-market use of the drug, however.

    For the
    Investor
    The clinical trial process is costly as well as
    time-consuming. Estimates as to the cost of pushing a drug
    through clinical trials range from between $350 million
    and $500 million. Investors interested in early stage
    companies should factor in the costs, risk, and extended
    time to market required for FDA approval.

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • EARLY RESULT PROMISING-OVERVALUED
      6 years
      clinical trial then FDA discove
      RISK~~~~6 years
      clinical trial then FDA discover side effect.
      FDA will
      disapprove 90% DRUG application.

      Waste of money.
      TIME..................................For the Investor
      The clinical trial process is
      costly as well as time-consuming. Estimates as to the
      cost of pushing a drug through clinical trials range
      from between $350 million and $500 million. Investors
      interested in early stage companies should factor in the
      costs, risk, and extended time to market required for
      FDA approval.

    • 6 years clinical trial then FDA
      discove
      RISK~~~~6 years clinical trial then FDA discover side
      effect.
      FDA will disapprove 90% DRUG
      application.

      Waste of money.
      TIME..................................For the Investor
      The clinical trial process is
      costly as well as time-consuming. Estimates as to the
      cost of pushing a drug through clinical trials range
      from between $350 million and $500 million. Investors
      interested in early stage companies should factor in the
      costs, risk, and extended time to market required for
      FDA approval.


      --------------------------------------------------------------------------------

    • 6 years clinical trial then FDA
      discove
      RISK~~~~6 years clinical trial then FDA discover side
      effect.
      FDA will disapprove 90% DRUG
      application.

      Waste of money.
      TIME..................................For the Investor
      The clinical trial process is
      costly as well as time-consuming. Estimates as to the
      cost of pushing a drug through clinical trials range
      from between $350 million and $500 million. Investors
      interested in early stage companies should factor in the
      costs, risk, and extended time to market required for
      FDA approval.

    • NOTHING EVEN CLOSE TO 4 YEARS
      The Clinical
      Trial Process ( 4 )--2006 YEAR

      If the company
      moves on to begin Phase 2 trials, the drug's chance of
      eventually making it to market improves to just under
      30%.

      Phase 2
      Phase 2 trials consist of small,
      well-controlled experiments to continue to evaluate the drug's
      safety and assess side effects. The drugs are given to
      volunteers (usually between 100 and 300 patients) who
      actually suffer from the disease or condition being
      targeted by the drug. This phase is where the optimal
      dosage of the drug is established. Also, statistical end
      points are established for the drug that represent the
      targeted favorable outcome of the study. The current
      standard of care for the medical condition can be used as
      a benchmark in setting the end point. Phase 2
      trials last an average of two years.

      A drug that
      moves on to begin Phase 3 testing has about a 60%
      chance of actually being approved by the FDA.


      Phase 3
      Phase 3 testing is intended to verify the
      effectiveness of the drug against the condition that it
      targets, based on the statistical end points established
      in Phase 2. The study also continues to build the
      safety profile of the drug and record possible side
      effects and adverse reactions resulting from long-term
      use. Phase 3 studies are tightly controlled,
      double-blind studies with a sample size of at least 1000
      patients. If the drug proves to be effective in this stage,
      the trial is deemed successful (pivotal). Normally
      two pivotal trials are required to ensure the
      validity of the studies, although if the results are
      extremely strong, one may suffice. Phase 3 testing averages
      between three and four years.

      Assuming the drug
      reaches the desirable end point in Phase 3 trials, the
      company will then file a New Drug Application, which can
      contain 100,000 pages of data supporting the efficacy and
      safety of the drug. At this point, the drug has better
      than a 70% chance of being approved by the FDA.


      Approval of the NDA can take anywhere from two months to
      an extreme of several years (in the case that the
      FDA requests additional information), with an average
      wait of between 18 and 24 months. Upon approval, the
      company may begin to market and distribute the
      drug.

      Phase 4
      Once the drug is on the market, the company
      must continue to perform observational studies in an
      ongoing evaluation of the drug's safety during routine
      use. The company also attempts to monitor any usage of
      the drug for conditions other than the approved
      medical indication. If the drug is being successfully
      used for off-label indications, the company will often
      initiate further clinical trials for those indications in
      order to widen the potential market for the drug. The
      company cannot advertise or endorse off-market use of the
      drug, however.

      For the Investor
      The clinical
      trial process is costly as well as time-consuming.
      Estimates as to the cost of pushing a drug through clinical
      trials range from between $350 million and $500 million.
      Investors interested in early stage companies should factor
      in the costs, risk, and extended time to market
      required for FDA approval.


      --------------------------------------------------------------------------------

    • 6 years clinical trial then FDA
      discove

      RISK~~~~6 years clinical trial then FDA discover side
      effect.
      FDA will disapprove 90% DRUG
      application.

      Waste of money.
      TIME..................................For the Investor
      The clinical trial process is
      costly as well as time-consuming. Estimates as to the
      cost of pushing a drug through clinical trials range
      from between $350 million and $500 million. Investors
      interested in early stage companies should factor in the
      costs, risk, and extended time to market required for
      FDA approval.


      --------------------------------------------------------------------------------

    • 6 years clinical trial then FDA
      discove
      RISK~~~~6 years clinical trial then FDA discover side
      effect.
      FDA will disapprove 90% DRUG
      application.

      Waste of money.
      TIME..................................For the Investor
      The clinical trial process is
      costly as well as time-consuming. Estimates as to the
      cost of pushing a drug through clinical trials range
      from between $350 million and $500 million. Investors
      interested in early stage companies should factor in the
      costs, risk, and extended time to market required for
      FDA approval.

    • 6 years clinical trial then FDA
      discove
      RISK~~~~6 years clinical trial then FDA discover side
      effect.
      FDA will disapprove 90% DRUG
      application.

      Waste of money.
      TIME..................................For the Investor
      The clinical trial process is
      costly as well as time-consuming. Estimates as to the
      cost of pushing a drug through clinical trials range
      from between $350 million and $500 million. Investors
      interested in early stage companies should factor in the
      costs, risk, and extended time to market required for
      FDA approval.

    • 6 years clinical trial then FDA
      discove
      RISK~~~~6 years clinical trial then FDA discover side
      effect.
      FDA will disapprove 90% DRUG
      application.

      Waste of money.
      TIME..................................For the Investor
      The clinical trial process is
      costly as well as time-consuming. Estimates as to the
      cost of pushing a drug through clinical trials range
      from between $350 million and $500 million. Investors
      interested in early stage companies should factor in the
      costs, risk, and extended time to market required for
      FDA approval.

      -----------------

    • 6 years clinical trial then FDA
      discove
      RISK~~~~6 years clinical trial then FDA discover side
      effect.
      FDA will disapprove 90% DRUG
      application.

      Waste of money.
      TIME..................................For the Investor
      The clinical trial process is
      costly as well as time-consuming. Estimates as to the
      cost of pushing a drug through clinical trials range
      from between $350 million and $500 million. Investors
      interested in early stage companies should factor in the
      costs, risk, and extended time to market required for
      FDA approval.


      --------------------------------------------------------------------------------

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