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Posted On: 05/03/2018 9:53:21 AM
Post# of 72433
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Limited Population Antibacterial Drug Program -- by FDA.
https://endpts.com/glass-half-empty-achaogen-...s%20plunge
AKAO's drug is going to be approved for one indication (complicated urinary tract infections) but not another (blood infections).
Quote:
...the LPAD regulatory pathway allows for acceptance of greater uncertainty or higher risk in patients with serious diseases (and and unmet need) provided that substance evidence of effectiveness is presented
https://endpts.com/glass-half-empty-achaogen-...s%20plunge
AKAO's drug is going to be approved for one indication (complicated urinary tract infections) but not another (blood infections).
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