Replies to post #607595 on NorthWest Biotherapeutics Inc (NWBO)

[sbarn]

Actually, footnote 2 to the 10-Q (at page 12) clearly identifies the remaining one-time milestone as "drafting key portions of the application for product approval."

[hyperopia]

By george, I think you’re right. The 6 workstreams were completed. When I first read the 10Q a couple months ago, I read it the same way that you did; that the 6 workstreams were completed. But then I thought, that if there was 1 milestone left, and it was a part of the 6 workstreams, then there had to be one workstream uncompleted. But in rereading this section:

The Company had three operational programs with Advent: (a) an ongoing manufacturing program at the GMP facility in London, (b) an ongoing development and manufacturing program at the Sawston GMP facility, and (c) a one-time program for specialized work, organized into 10 sets of one-time milestones, for the following:

Qualifying for and obtaining 3 required licenses for the Sawston facility: a license from the Human Tissue Authority to collect and process human cells and tissues, a license from the MHRA for manufacturing for clinical trials and compassionate use cases, and a license from the MHRA for commercial manufacturing.

6 workstreams relating to product matters required for an application for regulatory approval of DCVax-L, including Comparability, Stability, Potency, Product Profile, Mechanism of Action and Fill/Finish.

Drafting of key portions of the application for product approval itself.

Each of the three operational programs is covered by a separate contract. The ongoing manufacturing in the London facility is covered by a Manufacturing Services Agreement (“MSA”) entered into on May 14, 2018. The development and manufacturing program at the Sawston facility is covered by an Ancillary Services Agreement entered into on November 18, 2019. The specialized work associated with the 10 one-time milestones is covered by an SOW 6 entered into under the Ancillary Services Agreement as of April 1, 2022 and amended on September 26, 2022.

there were actually 10 one-time milestones, broken down like this: 3 for obtaining each of the 3 required licenses for Sawston, 6 for completing the 6 workstreams, and 1 for drafting key portions of the MAA. So actually yes, the last milestone is identified.

The 3 licenses were obtained for Sawston, and the 6 work streams were completed, (so 9 milestones achieved for that) so all that was left to achieve after March, was for Advent to complete the “drafting of key portions of the application for product approval.”

So that’s actually pretty good news that all of the prerequisite workstreams were completed, and all that remained, was to finish the marketing application. This certainly sounds like a status update since the Annual Shareholder Meeting, to me at least.