Replies to post #690562 on NorthWest Biotherapeutics Inc (NWBO)

[Love Boat Captain]

Steady_T,

After a deeper look, I think you are correct.

ChatGPT:

The distinction between "acceptance" and "validation" in regulatory terms often hinges on what each step represents in the process:

1. **Acceptance**: This is when the regulatory body initially receives and acknowledges the application. It’s more about confirming that the submission has been received rather than assessing its content.

2. **Validation**: This step goes beyond mere acceptance by checking that all required documents, data, and components are included and meet the criteria set out by the regulatory body. This ensures that the application is not only complete but also organized according to specific regulatory standards.

Starting the review clock at validation rather than acceptance allows the regulatory authority to ensure that the application is truly review-ready and minimizes the risk of significant delays due to missing or incorrect information. If the clock started at acceptance, there could be potential delays right after if the application were found to be incomplete upon initial review. Therefore, starting the clock post-validation promotes a more efficient and effective review process.

Furthermore:

If your Annual Shareholder Meeting (ASM) is by the end of June, and the 150-day assessment phase started on January 24, 2024, the timeline calculation remains essentially the same with the phase concluding around June 23, 2024. This gives a slight buffer between the end of the assessment phase and your ASM. Here’s how this affects planning and expectations:

1. **Completion of Assessment**: With the assessment phase ending just before the ASM, this allows a few days for final preparations or to address any last-minute details or communications from the regulatory body.

2. **RFI Considerations**: As mentioned earlier, RFIs can still be issued during the assessment period. The timing of any RFIs, and the company’s ability to respond effectively, will be crucial. If RFIs are issued later in the phase, they could extend the review process, potentially impacting the information available at the ASM.

3. **Preparing for ASM**: It’s wise to prepare for the ASM with scenarios in mind that may include the latest regulatory status. Depending on how the assessment goes, you might need to inform shareholders about a successful completion or discuss potential delays and their implications.

4. **Communication Strategy**: Have a communication strategy ready for different outcomes from the regulatory review. This includes being prepared to discuss any RFIs received, how they were addressed, and their impact on the review timeline.

This slightly extended timeframe between the end of the assessment phase and the ASM provides a cushion that might be useful in managing last-minute regulatory communications or decisions.