According to the lawsuit, defendants made false and/or misleading statements and/or failed to disclose that:
- the MOLBREEVI (a clinical trial for the treatment of a rare lung disease) Biologics License Application (“BLA”) lacked sufficient information regarding MOLBREEVI’s chemistry, manufacturing, and/or controls;
- accordingly, the FDA was unlikely to approve the MOLBREEVI BLA in its current form;
- the foregoing made it unlikely that Savara would complete submission of the MOLBREEVI BLA within the timeframe that Savara had represented to investors;
- the delay in MOLBREEVI’s regulatory approval increased the likelihood that Savara would need to raise additional capital; and
- as a result, defendants’ public statements were materially false and misleading at all relevant times.
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