According to the complaint, during the class period, defendants failed to disclose that: (i) the MOLBREEVI Biologics License Application ("BLA") lacked sufficient information regarding MOLBREEVI's chemistry, manufacturing, and/or controls; (ii) accordingly, the FDA was unlikely to approve the MOLBREEVI BLA in its current form; (iii) the foregoing made it unlikely that Savara would complete its submission of the MOLBREEVI BLA within the timeframe it had represented to investors; and (iv) the delay in MOLBREEVI's regulatory approval increased the likelihood that the Company would need to raise additional capital.