Financial BurdenIf the agency requires a long-term, large Phase 3 study that would cost hundreds of millions of dollars and 5-6 years, that would be beyond QURE's means, and they would pursue a potential partnership.
Investor SentimentInvestor reactions to QURE's previous updates have been lukewarm.
Regulatory UncertaintyThe path forward for accelerated approval for AMT-130 is still a little unclear.