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id: 846, Created by Stan Vick, Scout
Spero Therapeutics (SPRO) Failed NDA Case
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E.D. New YorkCourt
- Spero announced that it immediately deferred commercialization activities for tebipenem HBr.
- On this news, $SPRO fell 63.65%, damaging shareholders.
- Investors suspect hiding that the data for Tebipenem HBr's FDA approval was insufficient, making approval unlikely.
On May 3, 2022, Spero (SPRO) issued a press release announcing "that it will immediately defer current commercialization activities for tebipenem HBr based on feedback from a recent Late Cycle Meeting with the FDA regarding Spero's NDA for tebipenem HBr" and that, "although the review is still ongoing and the FDA has not yet made any final determination regarding approvability, the discussion suggested that the data package may be insufficient to support approval during this review cycle."
- Specifically, the FDA advised the Company that the FDA's separate analysis of the relevant study population had "reduced the number of evaluable patients in the primary analysis population compared with those resulting from the trial's pre-specified micro-ITT population as outlined in the statistical analysis plan" and as a result, the FDA considers that the pre-specified non-inferiority margin of -12.5% was not met."
- Further, the press release advised that "in connection with this development, Spero announced that it is undertaking a reduction in its workforce by approximately 75% and a restructuring of its operations to reduce operating costs and reallocate resources."
On this news, $SPRO fell 63.65%, damaging shareholders.
Earlier, on March 31, 2022, Spero disclosed that the FDA had notified Spero that, as part of its ongoing review of Spero's NDA for tebipenem HBr, it had identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.
On this news, $SPRO fell 18.27%.
Taking all facts into account, Investors have reasons to suspect that Spero misled shareholders by not revealing that the data for Tebipenem HBr's FDA approval was insufficient, making approval unlikely in its current form, requiring a major workforce reduction and operational restructuring at Spero.
Failure to Disclose,
Shock Event Date
03 May 2022
26 May 2022
Hon. LaShann DeArcy Hall