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Novatti banking license application .IBOA, page-50

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    Just in case you are new to biotech, the Holy Grail is usually FDA approval to be able to sell in the US.

    FDA approval requires three trials sequentially (sometimes reduceable to two trials if FDA grants the exemption).
    Phase 1 trial tests that the drug does not harm healthy individuals.
    Phase 2 trial tests that the drug provides some benefit.
    Phase 3 trial is a further test if Phase 2 has positive outcome.

    After these trials (which can take several years each) you apply for FDA approval which can take another 6 months.
    After approval you start your marketing campaign which takes a few months.
    Then you sell and get revenue.
 
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