I am not sure on the "rules" for clinical trials but I believe a Phase 3 would be compulsory before approval for marketing.
The only variation might be if the target infection was a critical number of serious cases with no known treatment. Currently it seems the infections can be controlled to some degree unless they turn to sepsis.
The phase 3 would be same test but just with a larger broader cohort of patients, and I assume the idea is to increase the exposure and therefore risk of adverse reactions. Just the fact the treatment gives 100% response in phase 2 would not mean no phase 3 required I believe. If phase 3 did give same results we have seem to date then surely path to market would be expedited. I would also expect to see more emergency access requests and approvals after safe completion of current phase 2. Surely doctors at fiona Stanley would want to keep having access every time they come across a stubborn or aggressive infection.
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