Ann: Phase I/II UTI/Urosepsis Rapid Infusion Trial Complete, page-41

Someone may like to confirm or clarify my understanding here:

1. Different R327 IV dosing regimes and quantities are acquired from healthy volunteers without a UTI.
2. Their urine is collected. This contains R327 and metabolites of certain ages.
3. Urine from a third party is doped with the bacteria that R327 would be used to treat.
4. The urine containing R327 is then mixed with the infected urine, and the survival / kill rate of those bacteria are monitored over a meaningful timeframe.

This is effectively a proxy simulation of performing a controlled experiment on a UTI patient, but without risk to that patient.

5. The results of this are generally very effective, proving the efficacy of the drug for its purpose, but without actually relying on it to achieve a kill in an actual UTI patient. This ensures that no patient was harmed as part of the experiment, nor left untreated without providing current standard of care for UTI.

This sounds like a well designed experiment. I assume that the programs next stage will be to dose actual patients with UTI based on the optimum drug dose and infusion time that has been shown to be safe and effective.

If I have this correct, could someone kindly explain to why this is a bad thing, rather than a prudent and medically approved and sanctioned investigative trial? Have I missed something material, or is the alternate aim of all the critical posting on here simply a desire to kick the CEO for reasons unrelated to any required trial process timetable?