Market Opportunity And Growth ConcernsThere is not sufficient evidence to justify a $500M US market opportunity for Molbreevi.
Physician Engagement And Testing ChallengesThere seems to be some reluctance among physicians regarding patient testing, which is concerning since one of Savara's main strategies is targeting physicians and increasing testing.
Regulatory And Manufacturing RisksThe biggest risk to approval is manufacturing, as the current partner GEMA has never had a FDA approved product.