Ann: R327 added to WHO List of Antibacterial Products, page-20

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19/06/24

11:11

Post #: 74386029
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Originally posted by Grainger: ↑

With the current operating strategy for phase II they need 30-40 people with a UTI to recruit and be treated. Stratify them into different dosing regimes. Path tests of a few days after. Independent review panel review 3 months. All done inside 8 months.

Phase III studies are likely to be much bigger, but seriously if you have sepsis secondary to a UTI you are dying without prompt effective treatment. You will take the treatment. If you are alive 3 days later the treatment worked. No long follow up. Lets say recruitment takes a year you are still done inside 18 months.

On top of this they will need probably another 6-9 months for the FDA to agree on trial design. Still on track.

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Exactly! They should be all done with a P2 in 8 months. It has been eight YEARS since IPO. How is this "on track"?

And that's for an IV trial. Topical should be much quicker due to easier registration requirements and pathways.

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