NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

nice post Doc and I agree with much of what you wrote.

I have questioned why the direct trials have not started, especially since they had funding after the Swaston real estate sale, the direct contract was negotiated with Cognate, and clinical trials were approved (or nearly approved) with the FDA. I'm not buying the excuse that resources were too tight, so what you say makes some sense. I know that Northwest Bio’s management was “very happy” with the revised SAP, and it likely spells out expedited pathways. Linda Powers has said on a couple of occasions that she thinks L & D are essentially the same (partially matured dendritic cells). Here’s a quote by her at the Oppenheimer Healthcare Conference many years ago (courtesy of RK Matters):

“Now this is the platform technology that I have explained.  It is embodied into two key product lines, two major products. The first one that you see up there, DCVax-L, is for all types of operable tumors, and the second one is for all types of inoperable tumors. Both of the products use the same two key ingredients: that's the immune cell, the dendritic cells themselves, and the biomarkers of the tumor that we want the immune system to hit.  The difference between the two products is just in how we get the biomarker ingredient.  With the product for the operable tumors, when the tumor’s surgically removed in the operating room, they just drop the tissue in a kit and send the kit to us. It literally takes a couple minutes in the operating room.  And then we process it and we get the biomarkers from that tumor tissue.  Well for the inoperable tumors, we don't have the tumor tissue to get the biomarker, so instead we activate the dendritic cells in a little bit different way.  We directly inject them into the tumor, in the body, and the dendritic cells pick up the biomarkers on-site, in the tumor, and from there on out they operate the same, to mobilize the immune system.”
 
I also agree that with exceptional data, an expedited pathway, or rolling submission will be likely. I know they have been in close contact with the FDA throughout the year, and I think this may be one of the reasons Linda said that it will take a few weeks to review the data with their Scientific Advisory Board, as they may be sharing key data with other entities, including the FDA, prior to public notification.

7. Pre-BLA/NDA meetings:

* The purpose of the meeting is to discuss the planned content of the application with the appropriate CBER review division. Applicants are strongly encouraged to request this meeting. ?

* The pre-BLA/NDA meeting should be requested sufficiently in advance of the planned submission of the application to allow for meaningful response to CBER feedback and should generally occur not less than two (2) months prior to the planned submission of the application. Thus, the meeting request should be submitted at least four (4) months prior to application submission. ?

https://www.fda.gov/media/84040/download

I’m also sure that with good data, there will be great interest in the DCVax Platform by multiple BP’s, including Merck. BTW - Is this what you are referring to WRT Merck’s manufacturing? MERCK’S CUTTING EDGE FACILITIES TAKE MANUFACTURING TO NEW HEIGHTS https://www.merck.com/about/featured-stories/flex-center.html

I agree with Know-Fear about the “optimized” work in Germany, and sometimes have trouble with your (innuendo) writing style. I have thought “optimized” referred to the manufacturing process using automated tangential flow filtration system that was implemented at the same time. I know it was considered “state of the art” back then, but it’s really not any more. Is this what you are referring to?

(page 27) Manufacture of the immunotherapeutic DCVax®-L for brain tumor patients

The manufacturing process for the immunotherapeutic DCVax®-L has been optimized and implemented as part of a clinical trial conducted by American biotech company Northwest Biotherapeutics, Inc. The therapeutic approach is based on autologous dendritic cells and aims to improve the treatment of glioblastoma, a particularly aggressive type of brain tumor.

https://www.izi.fraunhofer.de/content/dam/izi/en/documents/Publications/AnnualReport_IZI_2017_short.pdf