Replies to post #720779 on NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

Investor082,

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175104521

[theorysuit]

Why would a BP partner with this inept management? A partner is someone who can execute....BP might buy them out for pennies on the dollar, but they will most definitely not partner. That is straight up given. They are 4 years since data lock/10 years since enrollment was complete with a sordid history of unbelievably slow execution and pumping PRs.....They still don't have any approval and have only submitted one submission to a non-relevant to revenue country. They haven't started the NICE reiumbursement plan. At this rate, they won't even have any other RA submission in 2025. There is no revenue anywhere in the near future. Dilution is going to be nonstop and the only certain thing that is going to happen.

[kabunushi]

You're making another negative WAG. Two in fact 1. Flaskworks is not going to be ready to be deployed in clinical trials for another year and 2.Commercial approval will likely take 2 years or more. I don't accept that a clinical trial will be necessarily be required to certify Flaskworks as a replacement to the artisian method. It's automation, not a complete reinvention of the process. I'm not an expert on this kind of engineering but what basis if any do you cite for your claim?

[flipper44]

Don’t be dense. If you were the CEO of another company, would you pay for a combo deal if DCVax-l was not approved? No. So your point is moot.

Would you pay to start a combo trial with artisan if you knew EDEN was almost ready? No. So your point is moot.

[The Danish Dude]

Ahhhh ... yet more profound bullshit.

There will be no need for any biosimilarity trial. People claiming so either have no idea about where the winds are blowing at the FDA, or they have but have an incentive bullshitting about it.

Let's not bullshit any further. We all know.

Lets take a peek at biosimilarity, especially the go to guy in all matters of biosimilarity, Dr. Niazi

$NWBO

Lets look into FDAs stance on biosimilars. And remember this guys name Sarfaraz Niazi Ph.D., SI, FRSB, FPAMS, FAACC. He is a regular one man army regarding FDAs stance on biosimilarity.

Lets see what he wrote about MHRAs stance first.https://t.co/VepkDZuGUN

— 🇩🇰 The Danish Dude 🇬🇱 (@FlemmingBruce) February 6, 2024

And lets look into FDA and MHRAs guidance on these matters. There will be no f...ing trials on biosimilarity on DCVax-L.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173377539

And lets enjoy whats coming

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173377539

[kabunushi]

Here is the path to biologic equivalence according to LP at the ASM [highlighting below is mine]. What part of no clinical trial is required don't you understand? Please explain where you get your claim that a clinical trial will be required to certify Eden for commercial production.

So now that the adaptation for clinical grade GMP, that design work has been done. The remaining steps are; complete the the streamlining, or condensing some of the portions of it, get the units ordered, have the units delivered, and then Advent will need to conduct a large amount of, what are referred to as, engineering runs. They're practice runs. You have to run, do practice runs with the Flaskworks machine in the Sawston facility, collect all the data, compare the data with the data from the DCVax products produced by the existing manual process, because they have to show, they have to demonstrate to the regulator, not only that the Flaskworks machine operates properly, doesn't shed particles into the clean room air, things like that.

We have to show that it produces a product that's the same, or as close to the same, as a biologic product can be. So they'll be in addition, after they do all of these engineering runs, and they collect all the data, they'll do comparability studies, equivalency studies, and collect the data from that. And then all of that will be submitted to the regulator, and the regulator will give approval. And this will all be going on, these are all things, all going on in parallel. Right? So this will be going on over the coming months, at the same time that the MAA process is going on, and the same time that the inspections are going on, and so forth. So it's not stretching out, you know, to infinity. It's parallel. What else on this? I think that's enough.