Replies to post #666014 on NorthWest Biotherapeutics Inc (NWBO)

[sukus]

Very interesting dstock.

[exwannabe]

If you check carefully, you can see that Merck has no vaccines in any form pending for approval. For Merck to start massive constructions of vaccine manufacturing facilities with crazy working hours and hire all high-caliber talents in the area of immunology, cell therapy, and cell manufacturing, Merck must have seen something definitive. There is nothing more definitive than DCVax-L. Period!

Merck was the worlds largest vaccine manufacture pre COVID. They had over $10B in vaccine sales last year. They are doing extensive R&D in addition to having mfg ops.

On the specific assertion of no pending approvals, That is beyond belie for a company that gets several approved every year, .This is one example just accepted for priority review last month

The deal with Daiichi which has the FDA approved oral CSF1R inhibitor, the only one on this planet also gives us the indication that Merck is aiming at including plx3397 in the further combination trial which has been going on for several years at UCLA.

The Diachi deal was specifically for ADCs, did not include 3397.

[sukus]

Dstock,

Good jobs.

High quality large storage freezers with millions capacity are being used by Advent currently. These equipments and storages are key for Dendritic Cells vaccines. We know why.

https://www.adventbio.uk/coldstorage

If Merck also installed similar freezers, I believe that is a big hint and that can be a key clue that Manufacturings of Dendritic Cells in the US are being prepared potentially by Merck.

I agree with you 100% that in order to gain a blessing from FDA, NWBO needs to start preparing DC vaccines manufacturing ahead of time with no delay either through potentially CRL or like you said Merck. And it is very interesting, Merck suddenly developed huge manufacturings 24/7. Why rushing? 💡



Without proof that manufacturing is ready, FDA might not give a green light.

All imho.

[skitahoe]

Dstock,

I'm aware that the EDEN system offers a great deal of flexibility as to how it can be used. Frankly the disposable cassette is a sealed unit, a case could probably be made for only loading and unloading the cassette in a cleanroom, but operating the EDEN in a somewhat lessor space, but I don't believe they're considering doing that. I don't believe that there would be a limit set on how many EDEN units can be located in one large cleanroom, but clearly every unit would need to have security for things like power outages, etc.

Unless the optimizing of the EDEN has resulted in dramatically lowering the time required to make one batch of vaccine, each EDEN will only make about 50 batches a year. If we truly are authorized to provide batches of DCVax-L for many solid cancers the need for virtually hundreds of thousands of EDEN units are likely to be needed. I could eventually see EDEN units being contained in racks installed in environmental cabinets, all located in cleanrooms, but stacked in a manner intended to maximize the number that could be contained in a given space. I suppose if you take robotics far enough, robots could load and unload the cassettes in each unit, but I wouldn't expect that in the immediate future unless Musk acquires the company.

I don't know if anyone has any idea of how many cancer patients in the last few years have had their tumors properly preserved. I would suspect that many Drs. and patients researching technology in development would have run into DCVax-L for GBM and other cancers. The cost of cryogenic storage isn't that great. Of course some of these patients are no longer with us, but I wonder if the demand immediately after approval won't come from thousands, or more, who've had their tumors properly preserved and still have a chance with the vaccine. For those who couldn't possibly afford getting the vaccine under compassionate use in the UK, this would be an affordable alternative. Of course in the beginning, only UK citizens would gain insurance coverage for the vaccine as I understand it. Approvals would have to come from elsewhere to permit patients access to the vaccine.

Gary