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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?
In commercial manufacturing, comparability studies submitted to regulators are rigorous and slightly onerous.
Validation of the device and validation of the device for its specific use are not the same.
But there has been years so if the company implemented side by side manufacturing and analysis they could have it done? If not, they could submit plans to perform the testing.
So, AF is babbling about Progression free survival, which was intended to be a surrogate endpoint for overall survival. DC-Vax causes pseudo progression, so the quicker “progression” could be a sign of efficacy of the product.
A more fair point is that a surrogate placebo was used owing to the crossover. The company has stated that the FDA required the crossover. It is usual for phase lll trial to have a placebo but not required.
Did they not recommend DCVax or Novocure or both?
Was the commercial manufacturing license request successful? Or are we in back and forth with licensing?
Basically they should be in a waterfall deliverable set now.
I hear what you are saying, but have seen the pro’s of the double blind.
I think with a large enough sample set for placebo and time considerations, it’s possible to generate a powerful surrogate placebo.
This will take a concentrated effort. I think participating sites would have to screen all patients and not just those participating in clinical trials, which would be a mentality change for both patients and clinicians. Also, additional sites could help the data set by adding data points. Thats JMHO.
In the mean time, NWBO maybe needs to sell the crossover design or stop using it.
Looking at the data, I think there is a fairly good chance that the FDA will accept trial. The product does no harm, the recurrent data is strong, the percentage OS long survival looks ok. With the right information, they could power up this therapy.
I think it has a chance. I would be more confident with gold standard double blind no crossover. But I think it could be approved or approved with confirmatory trial.
1-2 years working with a waterfall deliverable approach, working steadily.
Hopefully that comes through. If it does things should, slowly, start rolling (e.g. 8-14 months at a slow pace).
Did Advent get certified?
I believe it is the standard lead time from regulators
Site authorized (depends on audit), QP audit (2-3 months), apply to produce products EU (6-12 months), ect
I’d wager on Privatization
I think Roche is making their own DCs for iNeST. But big Pharma tends to partner, purchase, license, or crush. Also, other BPs may be interested as a counter. So I see it as on opportunity.
Because of iNeST?