The filed complaint alleges that Savara Inc. made materially false and/or misleading statements and/or failed to disclose that: (i) MOLBREEVI BLA, the treatment of pulmonary alveolar proteinosis, lacked sufficient information regarding MOLBREEVI’s chemistry, manufacturing, and/or controls; (ii) accordingly, FDA was unlikely to approve the MOLBREEVI BLA in its current form; (iii) foregoing made it unlikely that Savara would complete its submission of the MOLBREEVI BLA within the timeframe it had represented to investors; (iv) delay in MOLBREEVI’s regulatory approval increased the likelihood that the Company would need to raise additional capital; and (v) as a result, defendants’ public statements were materially false and misleading at all relevant times.