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The technology transfer could be on the auditors agenda. Ability to manufacture the product and quality management systems will be on the agenda.
Preparations for Regulatory Inspections. As previously reported, preparations for regulatory inspections associated with the MAA have been a major focus of the Company's activities this year to date, including mock inspections.
Inspections by MHRA are scheduled to take place in both the
U.S. and the U.K.
As a note, all can respond quicker than 30 days. I maxed the timeline.
Z,
This audit should be a kick the tires type audit, as opposed to a GMP audit which can be more of a deep dive.
Auditors will walk through the site and make observations. The observations will be minor, major, or critical. There may be some recommendations as well. The report will be provided pretty quickly after the audit. Each observation from the auditor requires reply. I am not sure how many days MHRA allows for reply, but I am estimating 30.
The responses will be submitted to the MHRA, who in turn have ~30 days to reply. There could be another round of back and forth with the observations. As NWBO is new to hosting regulators and they have two audits to complete, I added time to my timeline.
Hopefully they have phase appropriate GMP in place and can quickly complete the process.
It’s their first audit, performed at two sites.
I was originally estimating July for one on-site audit, and two months for back and forth with the auditor (what I called remediation).
I am adding another month for the USA site.
Hopefully the US and UK sites are getting audited this month. Estimating 2-3 months for remediation, that pushes us to October-December for news on the MHRA front.
They also PR ed a set of audits. So scheduling, actual audit, 30 days to deliver report, 30 days to respond to report, potential back and forth, and finalisations.
Audit is one of the last requirements.
I’ve always thought the business model needs a little tweaking at NWBO. I think it would make sense to have small production labs located in hospital facilities and only have centralised QC/ QA batch release. Especially if they can incorporate production instrumentation and environmental chambers / glove boxes. Just me rambling
Also, expect 1-3 back and forth exchanges, it is the auditors job to question. As long as the audited party can respond quickly this does not impact the timeline.
The timeframe is a deadline to reply. Early response is routine. The auditor will want to finish, they respond fairly quickly.
So I found the ASM confusing.
It sounds like there are some wins from last year.
I think she was speaking about audit readiness as opposed to requests for information.
Well, approval and licensing will ensure the company can survive bigger agency challenges. Governance needs to improve. Then more opportunities could emerge.
I tend to think that biotech and associated regulatory work to the latest deadline not the earliest. I am thinking September barring significant back and forth. But that’s pretty soon, no?
August / September is when I am hoping to hear results. Any guesses when we will hear?
Well, hopefully by fall we will have an answer at long last. After that a strategy, maybe a small trial with flask works and no crossover for FDA, EMEA, and Japan. Then start chasing different indications and DC Vax direct.
I’d like to see them implement a true company outside of a CMO.
It takes BP years to complete that type of comparability assessment. This little company will take much longer. Maybe they can kick it out for DCVax D, when or if that goes phase 2?
More support in the UK?
60 days from 21/22 of December 2023, right? Next month latest? Or do the holidays not count?
For this company, it would be some revenue and some security.
Would you see conditional approval?
I do not think the FDA will be that simplistic in their evaluation.
*dare to fail
It’s tricky though because placebo is actually late DCVax not no DCVax.
So by this time Advent should be up and hopefully the process is transferred. It’s time to submit.
In BP, it’s something like fail fast fail often push ahead. Here they need to date to fail.
The company is letting optics, rather than communications, drive the narrative
Is there any way for shareholders to get board members replaced?
This is my discontent, this should be NWBO
Do we own Sawton
Europe / UK are a little different..
The QP audit is a pre check to make sure the quality management system and manufacturing / manufacturing site have the right foundation. It’s basically a pre-inspection. There are a lot of moving parts to get approved and then to commercial, and NWBO is tiny, so I’d expect a slow timeline.
It’s not an issue, but these are big projects. They take time.
Ok, cool, the MIA is done.
Now they need to (if not already done) get the QP audit done, audit suppliers, validate their cleanroom and equipment, transfer the process and analytical methods and references/controls, prep stability protocols, ensure QMS, and file.
I assume senior management is focusing on the court case. If resolved in their favor, NWBO could be funded through commercialization.
Hopefully Advent is resolving the inspection observation. They should have responded to it by now.
The FDA will tell a company if they can go forward, not if they should.
Hopefully NWBO understands the technical deliverables and supply chain needed to produce this product.
Time has been passing, hopefully Sawton has right to operate and tech transfer started. After that, comparability assessments for flaskworks could start.
But if they are confident and have some money (CRL is expensive) then they should file with CRL as the manufacturing site and bring Sawton up when they have revenue.
Better idea yet, get NWBO it’s own site. CMO are not as good. They just are not. And the mark ups are insane.
I think they have a good shot, but they need to complete their technical deliverables.
They need to start with (super expensive) CRL because that is where the trial was performed. To use advent, technical process transfer needs to occur. So they either need a process chain that delivers to the UK (submit now with CRL) or get Sawton in right to operate (submit with Sawton).
I would appreciate if they submitted now.
Honestly, I suspect it is lack of transfer protocol and report. That one takes CAPA and TIme
I wish I knew the inspection observation(s) that are causing the delay. With that, we could estimate the time required to fix the problem.
It happens. Audits make company better and improve the general right to operate.
Well, MIA, QP audit and approval (right?), completed transfers from CRL to Sawton (right?), distribution partner, Insurance approval, submission, licensing, PR campaign, and then commercial manufacturing?
From the annual stockholder meeting, it sounds like they are still on manufacturing and quality process / transfer at the new site? I am not sure if this is right in terms of steps, anyone know? Manufacturing license for site, QP audit and storage delivery, nice submission, MHRA submission?