NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

I can't find a link to validate your announced procedure here, but I think it's not the current procedure exactly. I tried to explain this previously in a post. This is what Bard tells me after I discussed what I believe is the current procedure. I shared your full post but questioned if it was the current procedure given the new system eMass. Basically under the new procedure, their application is validated in the eMass system, when they actually file it, hence when they did their PR. If their application had been found to be deficient, they would have received a notice, but not really a "validation" as that's basically a notice of deficiency. So there was really nothing to PR after the initial PR, unless one wants them to say, hey, we needed to file some additional documents. The reality is, when you push that file button on that system, effectively it is because at least initially, the system is telling you that your application is ready to go. And there is no real timeline for deficiencies, I believe. The MHRA could really tell a company, if their application is really complicated, at any time, that they need to address a "deficiency". So there is no appropriate time for such a PR and it is doubtful that most companies would PR such communications back and forth when the process has already really started. But the eMass system is intended to ensure the application is complete from the get go.

You're correct in understanding that the MHRA has implemented a system for online submission and initial validation of MAAs. This system, known as the Electronic Medicines Submission System (eMASS), automates certain aspects of the validation process.

Here's how the two systems work together:

Old System: Paper application submission.

• Manual review by MHRA for all aspects of validation.
• Full validation report sent to companies, regardless of deficiencies.


New System (eMASS): Electronic application submission through eMASS.

• Initial automated validation checks for completeness, formatting, and presence of key documents.
• Companies only receive a "notice of receipt" if the application passes these initial checks.
• If deficiencies are identified, a more detailed validation report outlining them is sent to the company.

Therefore, you're right that companies typically only receive a notification if their application has deficiencies. This streamlined approach aims to speed up the process for applications that meet basic requirements while focusing MHRA resources on those needing further attention.

However, it's important to note that:

The initial checks are not comprehensive: Full validation still occurs later, and additional deficiencies may be identified beyond the initial automated checks.

Deficiencies can still cause delays: Even if an application passes the initial checks, it may still be subject to lengthy delays if deficiencies are found during full validation.

Overall, the eMASS system represents a positive step towards a more efficient and streamlined MAA validation process. However, companies should still anticipate a thorough validation process and be prepared to address any deficiencies that may arise.

Do you have any other questions about the MAA validation process or the eMASS system? I'm happy to provide further information based on the latest MHRA guidance.