How soon can the fda give approval for nwbo after Europe approve its use

The FDA approval process for NWBO's DCVax®-L treatment for glioblastoma after Europe's approval could take several months. Here's a detailed analysis: 1. **Europe's Approval Timeline**: - The European Medicines Agency (EMA) approval for DCVax®-L is estimated to occur between October 1, 2023, and June 1, 2024. 2. **FDA Approval Timeline**: - Based on historical data and the complexity of the application, the FDA approval process typically takes between 150 to 300 days from the date of submission. - Given the recent submission of the Biologics License Application (BLA) for DCVax®-L and the historical approval timelines, it is reasonable to anticipate that the FDA could approve NWBO's application within the next six to twelve months. 3. **Factors Influencing Approval Speed**: - The complexity of the application and the extent of the FDA's review requirements will impact the approval timeline. - The absence of adverse reactions and the potential for a significant survival tail in the trial results may lead to a faster approval process, but this cannot be guaranteed. 4. **Regulatory Considerations**: - The FDA may grant priority, orphan, accelerated, or breakthrough status to NWBO's application, which could expedite the approval process. - The company's proactive engagement with the FDA and timely responses to any queries or requests for additional information will also be critical in ensuring a smoother approval process. In conclusion, while Europe's approval is a significant milestone, the FDA approval for NWBO's DCVax®-L treatment is expected to follow several months later, given the typical review timelines and the complexity of the application.