Replies to post #449484 on NorthWest Biotherapeutics Inc (NWBO)

[beachhyena]

Spot on Flipper. Most of the space has been left open for rapid expansion of Flaskworks once approved.
One of the biggest bullish signals was when the company announced the start of manufacturing of specials for a single patient. Some shorts may have taken this lack of patients as a negative sign but for me this indicates how close we are to the point where patients in the UK will be able to get reimbursement from the NHS.
Something is brewing and I believe Dr Ashkan and the many patients awaiting DVAX-L are in the wings ready to receive treatment as soon as the floodgates are open through TLD/Journal and quick approval in the UK.

[ATLnsider]

I agree with this flipper44

[iwasadiver]

I agree with this completely Flipper

[StockFollower]

How Come Sawton can make DC Vax up to 50 patients per month and the US compassionate use program/right to try program is useless. We need to write our Congressional Representatives and Senators.

How Come we all we do is post on IHUB and are not contacting Joe Biden - whose son Beau died of Brain Cancer. He has a Moon Shot program to Cure cancer does not have NWBO front and center as a company who can likely cure 20 to 30% of GBM cases but is not challenging the FDA to approve DC Vax that is part of a trial that is still waiting for results after more than 12 years.

How Come we are not contacting all major news outlets and telling them about DC Vax? Remember around 2016 a company called Sarepta Therapeutics had parents pushing the FDA to approve their Duchenne Muscular Dystrophy drug. Their efforts help push this drug over the finish line. How Come we can’t do something similar.

I don’t post often but what are we accomplishing by posting to a message board when we can more effectively spend that time in a productive way by being pro-active Today, I decided to be like the parents of MD children and become an advocate for NWBO. Here is my first step.

I tweeted Dr Marc Siegel of Fox news asking How Come DCVAX is available to the UK on a compassionate use basis and the US is leading from behind. Maybe he will think it worth coverage at Fox news and do a follow-up story.

I plan to write President Biden and ask him How Come we have a Moon Shot program and Right to Try but there is no approval for DCVAX after more than 12 years. My Congress women and two senators are next.

We have many intelligent people on this board that should have their own How Come questions. Why not spend more time asking How Come and influencing the masses and less time posting to the IHUB message board.

Maybe we can make a difference the same way parents influenced the FDA to approve Sarepta Therapeutics drug for MD.

If you think this is a bad idea, I have to ask you - How Come? Let's take a new approach because we have a right to try!

[Horseb4CarT]

Yes I concur that given the clear benefits of the closed and automated manufacturing process are realized, the majority of manufacturing would be as such, and as it’s becoming apparent to me that a DCVax for GBM may be optimized somewhat differently for different types of tumors, the space and other efficiencies of Flaskworks based manufacturing will pay off even more so for making DCVax-L and Dcvax-xyz…. Concurrently in and across manufacturing facilities!

Call the Guinness people, I think I’ve broken the record for longest run on sentence :-)

[hyperopia]

Agree flipper, manual production will be history, but as I said before, I think there’s a reason that Northwest Bio gives an annual figure for it. And of course cold storage is critical regardless of the manufacturing method. The tumor tissue is shipped and stored in the -20C to -80C range, while the finished doses are cryopreserved and stored in the colder > -194C cryostorage.

I’m not sure if people understand how large the Sawston facility actually is, so I’ll throw some comparability numbers out there. Sawston is roughly double the size of Kite’s 44,000 square foot El Segundo CAR-T manufacturing facility, which Kite estimates is large enough to produce about 4,000 personalized cell therapy treatments annually. The shell size alone shouldn’t be used to compare with potential DCVax manufacturing capability, because this doesn’t account for the difference in manufacturing time or potential space utilization.

It seems reasonable to think that with process optimization using Flaskworks and other automated processes, DCVax-L manufacture time may be reduced from 8 days to 7 days, which is less than half the manufacturing time of Yescarta’s ~16 days. So given that Sawston is double the size and it takes half the time to manufacture DCVax, then theoretically, Sawston should be able to produce 4X Kite’s number, or 16,000 treatments annually using the whole Sawston facility, or the same number of treatments using 1/4 the space. (4,000 treatments using 11,000 square feet) But there’s more.

CAR-T manufacturers use individual all-in-one, end-to-end manufacturing work stations, which isn’t the most efficient use of space, as it ties up each individual work station during the long culturing step. If the Flaskworks system has one culture chamber, then the manufacturing capability would be approximately the same per space utilized. However, with Flaskworks system development, it’s conceivable that, by using larger media fill and waste tanks, and adding additional culture chambers and perfusion pumps, it could produce multiples of that in basically the same footprint. So by adding 10 culture chambers to each system for example, each manufacturing run could produce 10X the number of treatments in basically the same floor space. This might be what Michael Bigger was taking about when he said “cleanroom disruption.”