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ONYX Pharmaceuticals, AŞ Message Board

  • tommlly tommlly Aug 1, 2000 3:47 PM Flag

    WE WWE WILL CLOSE AT 14 TODAY

    TOMORROW 12 1/2, WHO WILL PAY SO TOMORROW???

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    • The Clinical Trial Process ( 4 )
      NOTHING EVEN
      CLOSE TO 6 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.

    • NOTHING EVEN CLOSE TO 6 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.

    • NOTHING EVEN CLOSE TO 6 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.

    • NOTHING EVEN CLOSE TO 6 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.

    • NOTHING EVEN CLOSE TO 6 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.

    • NOTHING EVEN CLOSE TO 6 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.

    • <EOM>

    • WHO CARE.
      WHO CARE, WHO ,CARE, WHO CARE,WHO
      CARE.WHO CARE.WHO CARE.WHO CARE.WHO CARE.WHO CARE.WHO
      CARE.WHO CARE.
      WHO CARE, WHO ,CARE, WHO CARE,
      WHO
      CARE, WHO ,CARE, WHO CARE,
      WHO CARE, WHO ,CARE, WHO
      CARE,
      WHO CARE, WHO ,CARE, WHO CARE,
      WHO CARE, WHO
      ,CARE, WHO CARE,
      WHO CARE, WHO ,CARE, WHO
      CARE,
      WHO CARE, WHO ,CARE, WHO CARE,
      WHO CARE, WHO
      ,CARE, WHO CARE, TO LOSE MONEY.

    • BUY, BUY, BUY, BUY NOW. Early results
      promising--NOT RIGHT. 4 years clinical trial then FDA discovers
      side effects.
      FDA will disapprove 90% DRUG
      application. This is FACT.the company moves on to begin Phase
      3 trials, the drug's chance of eventually making it
      to market improves to just under 30%. WHO
      CARE.
      WHO CARE, WHO ,CARE, WHO CARE,WHO CARE.WHO CARE.WHO
      CARE.WHO CARE.WHO CARE.WHO CARE.WHO CARE.WHO CARE.
      WHO
      CARE, WHO ,CARE, WHO CARE,
      WHO CARE, WHO ,CARE, WHO
      CARE,
      WHO CARE, WHO ,CARE, WHO CARE,
      WHO CARE, WHO
      ,CARE, WHO CARE,
      WHO CARE, WHO ,CARE, WHO
      CARE,
      WHO CARE, WHO ,CARE, WHO CARE,
      WHO CARE, WHO
      ,CARE, WHO CARE,
      WHO CARE, WHO ,CARE, WHO CARE, LOSE
      MONEY.

    • ONXX IS 4 YEARS LATER DRUG-IF CAN GET FDA
      APPROVAL, NOT THE COMMING YEAR OR QUTER PRODUCT. Early
      results promising--NOT RIGHT. 4 years clinical trial then
      FDA

      discovers side effects.
      FDA will
      disapprove 90% DRUG application. This is FACT.the company
      moves on to begin Phase 3 trials, the drug's chance of
      eventually making it to market improves to just under 30%.

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