Replies to post #628257 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

The average time to approval goal from acceptance is 97% by or before day 80. This likely means the MHRA is working closely before and after presubmission, regardless of RR existence.

Again, sponsors of orphan designated drugs work extremely close with regulators in multiple jurisdictions including the UK. Sponsors and regulators are literally bound to assertively engage.

Specifically, with DCVax-l, we, the public, are simply not yet in a position to say either you or DD is closer to any timeline within the 150 day allowance. Nor are we in a position to know whether the clock off period will be utilized.

[dennisdave]

You are wrong on the 210 days and wrong on the clock starting on the acceptance of the submission

may depend on how long it takes Northwest Bio to respond to the MHRA’s information request.

IF NWBO is confronted (which I highly doubt) with an RFI of 60 days max (and by high exception that 60 days can be extended) then those 60 days include the 150-day assessment period. So its 80-day assessment, 60-day RFI, and 10-day phase 2 for the final decision. What you are saying is 210 days which it previously was. Can you provide me with a reliable source that says phase 2 of the application assessment takes 70 days?

The MHRA will evaluate a UK, Great Britain (England, Wales and Scotland) or Northern Ireland marketing authorisation (MA) application and reach an opinion within 150 days of a valid application being submitted. CHARLOTTE TILLETT partner https://www.stevens-bolton.com/site/insights/articles/uk-marketing-authorisation

Additionally, the assessment clock doesn't start until the application is validated, which could take up to 2 weeks from submittal.

also wrong its after the submission of the application and also again the WITHIN 150 days

The assessment time has been reduced from 210 days to a 150-days assessment procedure for national MA applications containing new active substances. This new accelerated assessment route for MAs does what it says, within 150 days after submission of the application, the MHRA is expected to evaluate and reach an opinion.

https://ndareg.com/news/are-you-planning-to-go-for-approval-in-the-uk-here-is-what-you-need-to-know/ NDA NDA provides unmatched regulatory expertise, partnering with our clients

[CrashOverride]

The off clock period isn't required while approval could be done in 80 days or less if MHRA doesnt have additional questions. I believe a lot of this information was already completed with regulators knowing much given the MIA as well as our existing orphan status.

The assessment runs in two phases totalling 150 days with a 60-day clock off period between phases if needed. The first assessment phase will be completed 80 days after the clock starts. Any issues arising during the first phase will be raised with applicants in a "letter requesting further information" (RFI letter). These issues should be addressed within the clock off period. The guidance states that requests to extend the clock off period for up to a further 60 days "may be granted only for exceptions". Phase I assessment will also address eligibility for grant of orphan status.

The second phase of the assessment will start once the applicants' responses are received. The MHRA will operate a 'fixed submission date' system to facilitate consultation with the Commission on Human Medicines (CHM). The guidance recommends that applicants contact the MHRA Assessment Team ahead of their intended date of response submission to align with the CHM's meeting schedule.

https://uk.practicallaw.thomsonreuters.com/w-029-1301?transitionType=Default&contextData=(sc.Default)&firstPage=true

If Northwest Biotherapeutics and regulators move quickly then these phases can be completed in 80 days or less as that's what happens 97% of the time.

PM2
Area: Medicines licensing, assessment of applications
Target description:

a) The assessment of applications for New Active Substances (NAS) Marketing Authorisations for UK/GB - 97% assessed within 80 days (National including Orbis and Access Consortium)

Target: 97% assessed within 80 days

https://www.gov.uk/government/publications/medicines-and-healthcare-products-regulatory-agency-annual-report-and-accounts-2021-to-2022/the-medicines-and-healthcare-products-regulatory-agency-annual-report-and-accounts-202122

[JTORENCE]

hyperopia , looks like dennisdave blew your theory right out of the water. Read msg 628265. Have a nice day..

[sentiment_stocks]

I believe that just means that the first phase assessment is completed on time in 92% of cases, in preparation for the CHM meeting.

That is exactly how I read that section. Just sayin’.

[ilovetech]

hyperopia - Public trust in the healthcare system is at an all time low. I don't think there's an equivalent period that compares to the current status quo. I believe the RA's have a vested interest to resuscitate their reputation, and perhaps we may see DCVAX expedited to serve as a catalyst towards that end. Imo.

ILT