CUV 1.85% $13.28 clinuvel pharmaceuticals limited

Ann: Media release - First stroke patient with afamelanotide, page-11

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  1. 7,705 Posts.
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    Realistically you are looking at five years before any approval. The chance of success is <8% (on average).

    The median phase III trial in their data set cost $21.4 million, they reported last year in Nature Reviews Drug Discovery. The median phase II trial cost $8.6 million, and the median phase I trial cost $3.4 million, they also reported.

    https://www.nature.com/articles/nrd.2018.198

    From the FDA

    Step 3: Clinical Research



    Phase 2

    Study Participants:Up to several hundred people with the disease/condition.

    Length of Study: Several months to 2 years

    Approximately 33% of drugs move to the next phase



    Phase 3

    Study Participants:300 to 3,000 volunteers who have the disease or condition

    Length of Study: 1 to 4 years

    Approximately 25-30% of drugs move to the next phase





    https://www.fda.gov/patients/drug-development-process/step-3-clinical-research
 
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