The FDA's request for additional CMC information without raising concerns about clinical efficacy or safety is a mixed signal. It delays the approval process, potentially impacting Abeona's stock in the short term due to uncertainty. However, the absence of efficacy or safety concerns and the company's commitment to resubmitting in a reasonable timeframe could mitigate negative impacts. Investors might view this as a temporary setback rather than a fundamental issue with the drug's approval prospects.