BOT 1.41% 35.0¢ botanix pharmaceuticals ltd

Ann: Botanix receives A$4.6m R&D Tax Incentive refund, page-17

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    wiki has your answers for success rate at different phases: https://en.wikipedia.org/wiki/Phases_of_clinical_research

    Summary of clinical trial phases
    PhasePrimary goalDosePatient monitorTypical number of participantsSuccess rate[2]Notes
    PreclinicalTesting of drug in non-human subjects, to gather efficacy, toxicity and pharmacokinetic informationunrestrictedscientific researchernot applicable (in vitro and in vivo only)

    Phase 0Pharmacokinetics; particularly, oral bioavailability and half-life of the drugvery small, subtherapeuticclinical researcher10 people
    often skipped for phase I
    Phase ITesting of drug on healthy volunteers for safety; involves testing multiple doses (dose-ranging)often subtherapeutic, but with ascending dosesclinical researcher20–100 normal healthy volunteers (or for cancer drugs, cancer patients)approximately 70%determines whether drug is safe to check for efficacy
    Phase IITesting of drug on patients to assess efficacy and side effectstherapeutic doseclinical researcher100–300 patients with specific diseasesapproximately 33%determines whether drug can have any efficacy; at this point, the drug is not presumed to have any therapeutic effect whatsoever
    Phase IIITesting of drug on patients to assess efficacy, effectiveness and safetytherapeutic doseclinical researcher and personal physician300–3,000 patients with specific diseases25–30%determines a drug's therapeutic effect; at this point, the drug is presumed to have some effect
    Phase IVPostmarketing surveillance – watching drug use in publictherapeutic dosepersonal physiciananyone seeking treatment from their physicianN/Awatch drug's long-term effects



 
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