It is not possible to undertake a Phase II clinical trial without supporting results obtained from a successful Phase I trial.
The UTI study is a Phase II clinical trial based on the I.V. sepsis results.
The DFU study is a Phase II clinical trial based on the topical burns results.
Approval to commence those two new studies indicates acceptance of the success of the ongoing I.V. and topical burns clinical trials.
Ann: Expansion and Acceleration of Clinical Programs, page-51
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