Replies to post #44447 on NorthWest Biotherapeutics Inc (NWBO)

[Pyrrhonian]

What you are leaving OUT is DNDN piled on $640mm in debt through loans to build out after running TWO P3 trials both much larger than NWBO's. They then built THREE manufacturing plants that DNDN shareholders had stake in (unlike the build out Cognate is doing, of which a slice has so far been designated to NWBO--but probably only enough to make maybe 1,000 vaccines). From the most recent NWBO 10-k:

"The manufacturing of our product candidates will have to be greatly scaled up for commercialization, and neither we nor other parties in the industry have experience with such scale-up:

As is the case with any clinical trial, our Phase III clinical trial of DCVax-L for GBM involves a number of patients that is a small fraction of the number of potential patients for whom DCVax-L may be applicable in the commercial market.. If our DCVax-L, and/or other DCVax product candidates, are approved for commercial sale, it will be necessary to greatly scale up the volume of manufacturing, far above the level needed for the trials. Neither we nor our contract manufacturers have experience with such scale-up."

And Cognate will have a total of 67.5k sq ft of space after this build out:

http://www.commercialappeal.com/business/cognate-bioservices-to-undergo-947-million-expansion-ep-1193581019-323703911.html

But it's not all going to NWBO. In fact it sounds like most of it is going to other clients:

That's adding 32.5k sq.ft. and 80 employees. They have at the time of that writing 60 employees. What will they do with that space?:

"'What we are currently doing right now is expanding our manufacturing capacity,”'Cognate chief operating officer Mike Stella said. 'So we can grow with the companies that we currently have as well as bring on additional clients.'"

You have to read between the lines here:

"Cognate’s manufacturing facility for clinical-grade cell products is located in Memphis, Tennessee, near the airport. Memphis is a worldwide air shipping hub for both Federal Express and UPS. Cognate's facility is approximately 35,000 square feet and contains substantial expansion space in addition to the portions currently built out and in use. The current manufacturing facilities are sufficient to produce DCVax for at least several thousand patients per year — an amount well in excess of what is needed for the late stage clinical trial under way. There is a large amount of expansion space, which is already planned for build- -out in stages to allow for scale-up of production capacity in a modular fashion as the need increases for commercialization. This WOULD ALLOW Cognate's current facility to increase to a total capacity of some 5,000 patients per year." --2014 10-k

So as of 4/2014 they had 60 employees, 35k of space to serve their clientS. And as of summer 2015 they are moving forward to expand another 32k of space and add 80 employees, again for clientS. IF (and it's a big IF) they are getting 10k sq.ft. of that new space to make vaccine, and we use the 80k sq.ft. = 5,000 vaccines they give in presentations, then 10k = 640 vaccines a year. The portion of the existing 35k sq.ft. they have under use for DCVax is only enough to make for the P3 trial and P1/2 Direct trial. That's at best 6-7k sq.ft.

So YES, what they said in their 10-k is true: "Cognate's facility is approximately 35,000 square feet and contains substantial expansion space in addition to the portions currently built out and in use. The current manufacturing facilities are sufficient to produce DCVax for at least several thousand patients per year.." But it's NOT all currently under use just for DCVax. Then: There is a large amount of expansion space, which is already planned for build- -out in stages to allow for scale-up of production capacity in a modular fashion as the need increases for commercialization. This WOULD ALLOW Cognate's current facility to increase to a total capacity of some 5,000 patients per year." It WOULD ALLOW... All legalese right there telling you if they are ever to get to capacity to make 5k vaccines a year it is going to cost NWBO far more than they have already paid (which is already too much).

[DoGood_DoWell]

NB - facts are just so inconvenient to Pyrr's narrative. His story reads much better when you leave out the real relevant comparative data! One must wonder why he is trying so hard to paint such a slanted picture, but his efforts are certainly valiant. Hope he is getting a big paycheck for his fiction writing.