NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

DocLogic has been following product release closer than me, but mulling over the quoted paragraph below, and stay with me on this, makes me think the “substantial progress” they made would stand out much more now, but for the fact it has (likely) just been inspected in recent days/weeks, and if it passes, then a major announcement will be given, but for now, they gave us some idea of what they feel they have accomplished.

In other words, I think these product release streamlining improvement efforts are awaiting regulatory approval, which is likely part and parcel of the maa review. IMO.

Product Release Improvements.

We continued to streamline processes related to product release. After manufacturing, medical products must go through a range of “release tests” - i.e., quality control and other tests (composition, purity, potency, sterility, etc.) to be approved for release for use in patients. In order for scale-up of manufacturing to be effective, the product release process must also be streamlined and scaled up so that it is not a bottleneck. This is an important part of overall preparations for commercialization and is particularly critical for autologous (personalized) products, for which each “batch” of product that is released is only for one patient. We have been working on this for years and made substantial progress in 2023. Activities have included partial automation and acquiring specialized equipment and bringing in-house some key tests previously conducted by outside specialized vendors. — 2023 10k