Execution RiskExamples of other companies facing Refusal to File letters from the FDA suggest potential setbacks and execution challenges ahead.
Management ConfidenceConcerns arise because Savara management has not conveyed confidence that past mistakes will not be repeated, especially with ongoing dialogue with the FDA.
Regulatory ChallengesThere is added uncertainty and execution concerns due to the Refusal to File letter from the FDA, which could affect the approval process.