Based on the PR today it looks like Savara will continue to delay the trial until COVID has gone away. Listening to Badrul, the CMO of Savara, who was a director of the FDA, it is clear that the drug has a beneficial impact on PAP patients. IMPALA clearly shows that impact on PAP patients but the FDA is steadfast on P-Values, not patient outcomes. It will be years before Molgradex is in the hands of patients. FDA is really coming down hard on PAP patients in my view.
