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Re: None

Friday, 07/02/2021 1:18:53 PM

Friday, July 02, 2021 1:18:53 PM

Post# of 2201
JUST MY TAKE…

This letter, the company said, "identified deficiencies that preclude the continuation of the discussion of labeling and post marketing requirements/commitments at this time" for its antibiotic candidate sulopenem in treating uncomplicated urinary tract infections.
Key word =
pre·clude
/pr?'klo?od/

verb
1.prevent from happening; make impossible.
"the secret nature of his work precluded official recognition"
Similar: prevent
2.(of a situation or condition) prevent someone from doing something.
"his difficulties preclude him from leading a normal life"

My interpretation is that the “"identified deficiencies that (prevents the FDA) to continue to discuss labeling and post marketing requirements/commitments (only this part of the review) = (what ITRM needs to provide to FDA to satisfy) at this time for its antibiotic candidate sulopenem in treating uncomplicated urinary tract infections.
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