Replies to post #694029 on NorthWest Biotherapeutics Inc (NWBO)

[StonkMaster]

Thanks Lykiri, this all fits perfectly with what I've been hearing as well.

I don't want it to be the case, but I very much believe the 150 day assessment began on March 7th.

Important to note that today marks 80 days from March 7th, which means that Phase 1 should be close to concluding (or already has). I don't know if it would be made public or not, but the company should find out if a RFI / clock-off period will be required.

$NWBO MAA TRACKER

158 days from DEC 20 SUBMISSION

123 days from JAN 24 VALIDATION
27 days remaining (150 - no RFI)
87 days remaining (210 - with RFI)

80 days from MAR 7 CONFIRMATION
70 days remaining (150 - no RFI)
130 days remaining (210 - with RFI)

[sentiment_stocks]

Lykiri, as an aside, if you are correct and March 7 marked the confirmation that the company would be placed in the 150 day assessment pathway, it took MHRA almost 80 days to notify them of this… making the process more of a 230 day assessment, and that’s without a clock off.

[ATLnsider]

Thanks Lykiri! Do you also believe that March 7th marked the end of the DCVax-L MAA Phase 1 assessment period, and the start of the 80-Day Phase 2 assessment period?

[ae kusterer]

Lykiri:Then is the MAA approval date 150 calendar days from 1/24/24, or 150 business days from 1/24/24? Thanks.A.E.K.

Re: None

Sunday, May 26, 2024 8:10:22 AM

Post#
694029
of 694129
May 9, 2024

Lykiri

Re: ATLnsider post# 694104

Sunday, May 26, 2024 1:19:32 PM

Post#
694137
of 694139
I don't believe that March 7th marked the end of the phase1 assessment process

It seems logical that the 150-day assessment period began on January 24, 2024, when the initial validation was confirmed. The March 7, 2024, confirmation likely served as an additional administrative check within the ongoing Phase 1 review process to ensure all documentation was in place and that the application was qualified for the 150-day assessment route.



Les Goldman says "they are on track for accelerated approval (150- day assessment)" witch is new information.
We know that Northwest Biotherapeutics has requested the MHRA to allow the 150-day assessment route.

December 21, 2023

The MAA seeks approval for commercialization of DCVax-L for both newly diagnosed and recurrent glioblastoma (GBM). The application also requests to be considered under the MHRA’s rapid 150-day review pathway, which the agency has established for new medicines for serious unmet medical needs.


https://nwbio.com/northwest-biotherapeutics-announces-marketing-authorization-applications-submitted-uk-mhra-dcvax-l-glioblastoma/

The MHRA offers only a 150-day assessment timeline for all high-quality marketing authorisation applications (MAAs).

https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines

I believe that Northwest Biotherapeutics' MAA is well-qualified as a high-quality market authorization application.

October 13, 2023

“The Company strongly believes that after so many years of work on the DCVax-L program, taking some additional time to help ensure that the full MAA package is as strong as it can be is especially important since the Company plans to submit applications to multiple regulators.


https://nwbio.com/northwest-biotherapeutics-provides-update-on-near-term-plans-for-submission-of-marketing-authorization-application/
+ Les Goldman comment regarding accelerated approval in the UK. (Summer 2020)

CHATgpt

The criteria for qualifying for the 150-day assessment route in the UK are designed to ensure that the applications submitted to the MHRA meet specific standards of quality, safety, and efficacy. Here are some key criteria that pharmaceutical companies typically need to fulfill in order to qualify for this expedited review route:

1. **Comprehensive Data:** Applicants must provide a thorough and well-documented set of data on the quality, safety, and efficacy of the drug. This includes results from preclinical studies, clinical trials, manufacturing processes, and stability testing.

2. **Adherence to Good Manufacturing Practices (GMP):** The drug manufacturing facilities must adhere to Good Manufacturing Practices to ensure the quality and consistency of the product. The MHRA may conduct inspections to verify compliance with GMP standards.

3. **Compliance with Regulatory Guidelines:** The MA application should demonstrate compliance with relevant regulatory guidelines and requirements set forth by the MHRA and the European Medicines Agency (EMA), where applicable. This includes submitting all necessary documentation and following standardized procedures.

4. **Innovative or High Medical Need:** Drugs that offer significant therapeutic benefits for patients or address unmet medical needs are often prioritized for the 150-day assessment route. Innovative therapies or those targeting rare diseases may qualify for expedited review.

5. **Early Engagement with the MHRA:** It is advisable for applicants to engage with the MHRA early in the drug development process to discuss regulatory requirements, potential challenges, and any specific considerations for the application. This proactive approach can help streamline the review process.

6. **Risk Management Plan:** The application should include a comprehensive risk management plan to identify, evaluate, and mitigate potential risks associated with the drug, including pharmacovigilance strategies for monitoring safety post-approval.

7. **Benefit-Risk Assessment:** The applicant must provide a detailed benefit-risk assessment that weighs the therapeutic benefits of the drug against potential risks to patient safety. This assessment is crucial for the MHRA to evaluate the overall suitability of the drug for marketing authorization.

By meeting these criteria and submitting a high-quality MA application that aligns with the requirements set by the MHRA, pharmaceutical companies can increase their chances of qualifying for the 150-day assessment route and benefit from the expedited regulatory review process. This pathway aims to facilitate timely access to safe and effective medicines for patients while upholding rigorous regulatory standards.



I believe that Northwest Biotherapeutics' MAA is well-qualified and received confirmation as a high-quality market authorization application. Additionally, on March 7, the Company received confirmation that they were allowed to pursue the 150-day accelerated route. IMO

CHATgpt

The timeline for receiving confirmation that your Marketing Authorization Application (MAA) qualifies for the 150-day assessment route after submission to the Medicines and Healthcare products Regulatory Agency (MHRA) can vary depending on various factors. However, in general, the process typically unfolds as follows:

1. **Validation of MAA:** Upon submission of the MAA to the MHRA, the initial step is the validation process. During validation, the MHRA reviews the application to ensure that it contains all the necessary information and documentation required for assessment. This step typically aims to confirm that the application is complete and meets the basic regulatory requirements.

2. **Notification of Validation:** Once the validation process is complete, the MHRA will notify the applicant that the MAA has been validated. This notification typically confirms that the application has met the initial validation requirements and is proceeding to the next stage of assessment.

3. **Qualification for the 150-Day Assessment Route:** Following validation, the MHRA will then assess the application to determine if it qualifies for the 150-day assessment route. This assessment involves evaluating whether the application meets the specific criteria for expedited review under the 150-day pathway, as discussed in the previous responses.

4. **Confirmation of Qualification:** If the MAA meets the criteria for the 150-day assessment route, the MHRA will inform the applicant that their application has been qualified for expedited review. This notification typically confirms that the application will be subject to the accelerated 150-day timeline for regulatory assessment.

The time between the initial validation of the MAA and confirmation of qualification for the 150-day assessment route can vary, but applicants can generally expect to receive communication from the MHRA within a few weeks to a couple of months, depending on the complexity of the application and the workload of the regulatory authority.

It is important for applicants to engage proactively with the MHRA during the submission process, seek clarification on any requirements or issues that may arise during validation, and maintain open communication to ensure a smooth transition to the expedited review pathway if the application qualifies for the 150-day assessment route.

Overall, while the specific timing of notifications may vary, the MHRA strives to provide timely and transparent communication throughout the regulatory review process to support efficient evaluation of MA applications and expedite access to new medicines for patients in the UK.

ATLnsider

Re: Lykiri post# 694029

Sunday, May 26, 2024 12:11:53 PM

Post#
694104
of 694139
Thanks Lykiri! Do you also believe that March 7th marked the end of the DCVax-L MAA Phase 1 assessment period, and the start of the 80-Day Phase 2 assessment period?
Bullish
BULLISH







NWBO
Northwest Biotherapeutics Inc (QB)



Re: None

Sunday, May 26, 2024 8:10:22 AM

Post#
694029
of 694139
May 9, 2024

Les Goldman says "they are on track for accelerated approval (150- day assessment)" witch is new information.
We know that Northwest Biotherapeutics has requested the MHRA to allow the 150-day assessment route.

December 21, 2023

The MAA seeks approval for commercialization of DCVax-L for both newly diagnosed and recurrent glioblastoma (GBM). The application also requests to be considered under the MHRA’s rapid 150-day review pathway, which the agency has established for new medicines for serious unmet medical needs.


https://nwbio.com/northwest-biotherapeutics-announces-marketing-authorization-applications-submitted-uk-mhra-dcvax-l-glioblastoma/

The MHRA offers only a 150-day assessment timeline for all high-quality marketing authorisation applications (MAAs).

https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines

I believe that Northwest Biotherapeutics' MAA is well-qualified as a high-quality market authorization application.

October 13, 2023

“The Company strongly believes that after so many years of work on the DCVax-L program, taking some additional time to help ensure that the full MAA package is as strong as it can be is especially important since the Company plans to submit applications to multiple regulators.


https://nwbio.com/northwest-biotherapeutics-provides-update-on-near-term-plans-for-submission-of-marketing-authorization-application/
+ Les Goldman comment regarding accelerated approval in the UK. (Summer 2020)

CHATgpt

The criteria for qualifying for the 150-day assessment route in the UK are designed to ensure that the applications submitted to the MHRA meet specific standards of quality, safety, and efficacy. Here are some key criteria that pharmaceutical companies typically need to fulfill in order to qualify for this expedited review route:

1. **Comprehensive Data:** Applicants must provide a thorough and well-documented set of data on the quality, safety, and efficacy of the drug. This includes results from preclinical studies, clinical trials, manufacturing processes, and stability testing.

2. **Adherence to Good Manufacturing Practices (GMP):** The drug manufacturing facilities must adhere to Good Manufacturing Practices to ensure the quality and consistency of the product. The MHRA may conduct inspections to verify compliance with GMP standards.

3. **Compliance with Regulatory Guidelines:** The MA application should demonstrate compliance with relevant regulatory guidelines and requirements set forth by the MHRA and the European Medicines Agency (EMA), where applicable. This includes submitting all necessary documentation and following standardized procedures.

4. **Innovative or High Medical Need:** Drugs that offer significant therapeutic benefits for patients or address unmet medical needs are often prioritized for the 150-day assessment route. Innovative therapies or those targeting rare diseases may qualify for expedited review.

5. **Early Engagement with the MHRA:** It is advisable for applicants to engage with the MHRA early in the drug development process to discuss regulatory requirements, potential challenges, and any specific considerations for the application. This proactive approach can help streamline the review process.

6. **Risk Management Plan:** The application should include a comprehensive risk management plan to identify, evaluate, and mitigate potential risks associated with the drug, including pharmacovigilance strategies for monitoring safety post-approval.

7. **Benefit-Risk Assessment:** The applicant must provide a detailed benefit-risk assessment that weighs the therapeutic benefits of the drug against potential risks to patient safety. This assessment is crucial for the MHRA to evaluate the overall suitability of the drug for marketing authorization.

By meeting these criteria and submitting a high-quality MA application that aligns with the requirements set by the MHRA, pharmaceutical companies can increase their chances of qualifying for the 150-day assessment route and benefit from the expedited regulatory review process. This pathway aims to facilitate timely access to safe and effective medicines for patients while upholding rigorous regulatory standards.



I believe that Northwest Biotherapeutics' MAA is well-qualified and received confirmation as a high-quality market authorization application. Additionally, on March 7, the Company received confirmation that they were allowed to pursue the 150-day accelerated route. IMO

CHATgpt

The timeline for receiving confirmation that your Marketing Authorization Application (MAA) qualifies for the 150-day assessment route after submission to the Medicines and Healthcare products Regulatory Agency (MHRA) can vary depending on various factors. However, in general, the process typically unfolds as follows:

1. **Validation of MAA:** Upon submission of the MAA to the MHRA, the initial step is the validation process. During validation, the MHRA reviews the application to ensure that it contains all the necessary information and documentation required for assessment. This step typically aims to confirm that the application is complete and meets the basic regulatory requirements.

2. **Notification of Validation:** Once the validation process is complete, the MHRA will notify the applicant that the MAA has been validated. This notification typically confirms that the application has met the initial validation requirements and is proceeding to the next stage of assessment.

3. **Qualification for the 150-Day Assessment Route:** Following validation, the MHRA will then assess the application to determine if it qualifies for the 150-day assessment route. This assessment involves evaluating whether the application meets the specific criteria for expedited review under the 150-day pathway, as discussed in the previous responses.

4. **Confirmation of Qualification:** If the MAA meets the criteria for the 150-day assessment route, the MHRA will inform the applicant that their application has been qualified for expedited review. This notification typically confirms that the application will be subject to the accelerated 150-day timeline for regulatory assessment.

The time between the initial validation of the MAA and confirmation of qualification for the 150-day assessment route can vary, but applicants can generally expect to receive communication from the MHRA within a few weeks to a couple of months, depending on the complexity of the application and the workload of the regulatory authority.

It is important for applicants to engage proactively with the MHRA during the submission process, seek clarification on any requirements or issues that may arise during validation, and maintain open communication to ensure a smooth transition to the expedited review pathway if the application qualifies for the 150-day assessment route.

Overall, while the specific timing of notifications may vary, the MHRA strives to provide timely and transparent communication throughout the regulatory review process to support efficient evaluation of MA applications and expedite access to new medicines for patients in the UK.

[hyperopia]

Lykiri, thanks for the thoughtful post. I agree that it’s likely that Northwest Bio’s marketing application was high quality, and did not require additional information to be requested from the MHRA, as stated in the 1st quarter report. I also agree that it is highly likely that the application has received priority review.

I personally don’t believe that we can deduce the exact timing of the final decision by the timing of the ASM, or anything that Les said, since the company will only have a general idea of where the MHRA is in the process (and because Les has not exactly been reliable about timing). It appears to me that they have passed the first assessment phase and are now somewhere in the second phase, but it is difficult to know how long this phase will take with the backlog of inspections, and understaffed inspectors at the MHRA. I say this because Les said that no negative disclosures were required in the quarterly report, and he was talking about scheduling site visits, which generally occur after the initial scientific assessment. The company may also be able to deduce where the MHRA is in the process, if their questions change from questions about the application itself, to questions about defining the label, (whether enough evidence was presented for the label to be broad - for all gliomas, or simply for nGBM and rGBM) and post-approval risk management plans, etc.

It seems somewhat irrelevant (to me) to be trying to determine exactly when the assessment started, and counting days in the 150-day assessment timeline when the MHRA hasn’t been close to completing a single assessment in this timeline that was established four years ago. Having said that - I personally don’t know what the second validation date of March 7th means, but I believe that it was determined on or by that date, that the application was complete, and of high quality, so no further information will be officially requested by the MHRA, and the application is entitled and “confirmed” to receive priority review.

I think that, for the purposes of the MHRA’s own timeline, (since they track this) the official assessment (and timeclock) started at the first MHRA validation date of January 24th. I believe that they intend to complete the assessment as soon as they can, but with backlogs, it may take more than 150 days. However, I’ve always hoped the MHRA could pull a rabbit out of its hat for Northwest Bio.