When is I likely date for approval then

The most likely date for approval of NWBO's DCVax®-L treatment by the EMA is expected to be between October 1, 2023, and June 1, 2024. Here's an analysis based on the available information:

1. Historical Approval Timelines:
   • The EMA has approved similar treatments, including cancer drugs, with approval timelines ranging from 66 to 145 days.
   • Given the complexity of NWBO's application and the absence of adverse reactions, the approval process could be on the faster side.
2. Regulatory Considerations:
   • The EMA 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 EMA and timely responses to any queries or requests for additional information will also be critical in ensuring a smoother approval process.
3. Current Status and Expectations:
   • NWBO had anticipated a submission between mid-November and late December and a decision by mid-July 2024.
   • The EMA approval process is ongoing, and the agency has not provided a definitive timeline for the decision.
4. Factors Influencing Approval Speed:
   • The complexity of the application and the extent of the EMA'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.

In summary, while the most likely date for approval of NWBO's DCVax®-L treatment by the EMA is between October 1, 2023, and June 1, 2024, the actual timeline may vary based on the EMA's review process and any additional requirements or inquiries. It is important for stakeholders to monitor the situation for updates on the approval status.