What do you expect MBOT to be FDA approved? Look at the current time that it's been since the submission, how long it's been. Also look at news, current events and FDA history and tendencies and tell me what is the most likely time you think FDA approval will come for MBOT..
7/3/2025 01:17am
**Microbot Medical (MBOT) is likely to receive FDA approval in Q3 2025.** Here's the analysis to support this conclusion:
1. **Submission and Review Timeline**: MBOT submitted the FDA 510(k) for its LIBERTY Endovascular Robotic System in December 2024. The FDA review process typically takes 90-180 days. If we consider the minimum timeframe, the FDA approval could be expected around March 2025. However, given the complexity of medical devices, a more realistic estimate might be closer to the maximum timeframe, extending into Q3 2025.
2. **Current FDA Review Status**: There is no official update indicating that the FDA review has been completed or delayed. The company has been actively engaging with the FDA and expects the decision during the second quarter of 2025. This aligns with Q3 2025, considering the typical review period.
3. **Company Preparations**: MBOT has been preparing for commercial launch post-approval. The company has shifted focus to preparing for commercial launch as it enters 2025. Appointments like Michael Lytle to lead Sales Operations & Analytics indicate enhanced commercial readiness, suggesting anticipation of FDA approval and readiness for an imminent launch.
4. **Historical FDA Tendencies and Current Events**: The FDA has been reviewing robotic surgical systems and has shown a cautious but expedited approval path for innovative devices. The company's interactions with the FDA have been described as "productive," which suggests a positive trajectory. However, geopolitical issues and uncertainties in regulatory approvals pose potential risks.
5. **Market Expectations and Analyst Sentiments**: Analysts suggest significant upside potential with a target price increase of over 250% from the current level. This optimism reflects market expectations of a successful FDA approval and a promising market entry for LIBERTY.
In conclusion, while there are potential delays due to uncertainties, the current timelines, company preparations, and market expectations strongly suggest that MBOT will be FDA approved in Q3 2025.