Replies to post #660413 on NorthWest Biotherapeutics Inc (NWBO)

[Bright Boy]

So... you're like all the rest. Already forgot about the incredible accomplishment of filing the MAA and on to the "What can you do for me next!!"

Besides, does it really matter if you know if it will be approved in 144 days or 150??? Most in the know suggest approval in record time!! 80 days or less.Check with your friends in the UK. My suggestion for you is to take a "time out" to "smell the roses" and let management decide what's important and what's not. According to my friends in Big Biotech, management has produced a miracle and in record time. One of my friends (CEO of a BP) said that if he were charged with approval and commercialization of a breakthrough technology, never seen in healthcare history, he would have assigned several hundred company pros to manage what Northwest did with 18 employees and a handful of consultants!!! Further, that they managed to secure the "DISCOVERY" with brilliant patenting, compliments of Linda Power's patent experience coupled with incredible internal security measures with regard to compartmentalization of "need to know" information and subsequent distribution among the consultants.

So back to your comment about the importance of the "ticking clock" and the exact approval date in the overall scheme of things in this great success story, dip your finger in a glass of water and when you remove your finger, note the difference in the water level and that's the measure of importance of a few days difference in the approval date.

Cheers,

BB

[ae kusterer]

1)Hyperopia:It has been stated, I believe, that the NWBO dc vax l MAA appllication is being done in an "acceterated approval" mode.And the timimg would there be govermec by an eighty day linitb fro filing to acceptance. Any thoughts on this?

Re: Bright Boy post# 660377

Sunday, December 31, 2023 6:43:46 AM

Post#
660413
of 660466
That’s incorrect BrightBoy. “Days To Acceptance” has everything to do with when the MHRA’s 150-day-assessment clock will actually start on Northwest Bio’s marketing application. And “what this has to do with approval,” is to attempt to more closely predict the approximate timing of the approval.

The MHRA’s assessment (and clock) does not start until the application has been validated. Regulatory Agencies first perform a technical validation of the marketing application to ensure that all of the essential elements that are required for scientific assessments are included, and that these elements are all organized and located according to the standard electronic Common Technical Document (eCTD) format. While it is true that the marketing application has been submitted by Northwest Bio, and received by the MHRA, it has not been “officially accepted” yet. And by the way, no they don’t “hand it back to the company” or “throw it in the trash” (it’s digital) but if the MHRA needs additional information to complete its validation of the application, it will ask the applicant to supply this by a certain deadline.

150-day assessment for national applications for medicines

Validation
The assessment timetable for new active substances and biosimilar products or existing active substances will begin after the validation of the application.

New active substances and biosimilar products
You should submit a valid, full application for evaluation. The accompanying cover letter should detail the intention to seek orphan status or MA under exceptional circumstances as applicable.

A valid application/dossier should include common technical modules (CTD modules 2-5) and a UK specific CTD module 1, consisting of an appropriate Risk Management Plan (RMP), UK PIP CC and/or compliance with UK Orphan Medicines requirements, when applicable.

The SmPC/PIL may be submitted as Word documents in the working documents folder. There is an option to put the UK specific SmPC PIL/Labelling text/mock-ups in the UK specific folder which is available within the eCTD structure.

Applications that refer to an ASMF should ensure that the file (including the restricted part) has already been submitted to MHRA and a suitable letter of access authorising MHRA to make reference to the confidential information in the restricted part of the ASMF should be provided.

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


2)660465

Bright Boy

Re: hyperopia post# 660413

Sunday, December 31, 2023 11:34:59 AM


So... you're like all the rest. Already forgot about the incredible accomplishment of filing the MAA and on to the "What can you do for me next!!"

Besides, does it really matter if you know if it will be approved in 144 days or 150??? Most in the know suggest approval in record time!! 80 days or less.Check with your friends in the UK. My suggestion for you is to take a "time out" to "smell the roses" and let management decide what's important and what's not. According to my friends in Big Biotech, management has produced a miracle and in record time. One of my friends (CEO of a BP) said that if he were charged with approval and commercialization of a breakthrough technology, never seen in healthcare history, he would have assigned several hundred company pros to manage what Northwest did with 18 employees and a handful of consultants!!! Further, that they managed to secure the "DISCOVERY" with brilliant patenting, compliments of Linda Power's patent experience coupled with incredible internal security measures with regard to compartmentalization of "need to know" information and subsequent distribution among the consultants.

So back to your comment about the importance of the "ticking clock" and the exact approval date in the overall scheme of things in this great success story, dip your finger in a glass of water and when you remove your finger, note the difference in the water level and that's the measure of importance of a few days difference in the approval date.

Cheers,

BB




3)Bright Boy

Re: None

Saturday, December 30, 2023 7:56:11 PM

Post#
660377
of 660465
All these posts about "Days To Acceptance"!!! What does that have to do with anything??? Northwest has been working with the MHRA for years. So they submitted a 1.7 million page MAA document asking for accelerated approval on Dec. 20th. What do you think they're going to do. throw it in the trash???It was accepted the day it was submitted and it sure as Hell wasn't handed back to the company. And by the way, what does all that have to do with approval??? Nothing!!! So don't fall for the bad guys fake timelines!!! Northwest already received the "Global Manufacturing License". What do you think the MHRA will do for the MAA/Marketing license app., say,"We were just kidding.!!, we gave you the manufacturing license, but we won't let you sell the product!!" I don't think so.

Cheers,

BB



4)hyperopia

Re: Bright Boy post# 660377

Sunday, December 31, 2023 6:43:46 AM

Post#
660413
of 660465
That’s incorrect BrightBoy. “Days To Acceptance” has everything to do with when the MHRA’s 150-day-assessment clock will actually start on Northwest Bio’s marketing application. And “what this has to do with approval,” is to attempt to more closely predict the approximate timing of the approval.

The MHRA’s assessment (and clock) does not start until the application has been validated. Regulatory Agencies first perform a technical validation of the marketing application to ensure that all of the essential elements that are required for scientific assessments are included, and that these elements are all organized and located according to the standard electronic Common Technical Document (eCTD) format. While it is true that the marketing application has been submitted by Northwest Bio, and received by the MHRA, it has not been “officially accepted” yet. And by the way, no they don’t “hand it back to the company” or “throw it in the trash” (it’s digital) but if the MHRA needs additional information to complete its validation of the application, it will ask the applicant to supply this by a certain deadline.

150-day assessment for national applications for medicines

Validation
The assessment timetable for new active substances and biosimilar products or existing active substances will begin after the validation of the application.

New active substances and biosimilar products
You should submit a valid, full application for evaluation. The accompanying cover letter should detail the intention to seek orphan status or MA under exceptional circumstances as applicable.

A valid application/dossier should include common technical modules (CTD modules 2-5) and a UK specific CTD module 1, consisting of an appropriate Risk Management Plan (RMP), UK PIP CC and/or compliance with UK Orphan Medicines requirements, when applicable.

The SmPC/PIL may be submitted as Word documents in the working documents folder. There is an option to put the UK specific SmPC PIL/Labelling text/mock-ups in the UK specific folder which is available within the eCTD structure.

Applications that refer to an ASMF should ensure that the file (including the restricted part) has already been submitted to MHRA and a suitable letter of access authorising MHRA to make reference to the confidential information in the restricted part of the ASMF should be provided.

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