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The drugmaker must produce initial results of a randomized controlled trial of a second course of the antiviral by Sept. 30 next year, the FDA told Pfizer in a letter dated Aug. 5.
The regulator said a formal plan for the clinical trial is expected to be finalized this month.
Pfizer is “working with the FDA to finalize a protocol to study patients who may be in need of retreatment,” and will provide details when available, a company spokesperson said.
