Spero Therapeutics Announces Special Protocol Assessment Agreement With FDA For Phase 3 PIVOT-PO Trial Of Tebipenem HBr
Portfolio Pulse from Benzinga Newsdesk
Spero Therapeutics has announced a Special Protocol Assessment agreement with the FDA for the Phase 3 PIVOT-PO trial of Tebipenem HBr. This agreement will guide the design, execution, and analysis of the trial, potentially expediting the drug's approval process.
July 31, 2023 | 12:07 pm
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The Special Protocol Assessment agreement with the FDA for the Phase 3 trial of Tebipenem HBr could potentially expedite the drug's approval process, which may positively impact Spero Therapeutics' stock in the short term.
The Special Protocol Assessment agreement with the FDA is a significant regulatory milestone that could expedite the approval process for Tebipenem HBr. This could potentially lead to increased revenues for Spero Therapeutics, positively impacting its stock price in the short term.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 100