NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

I know the world revolves around Northwest Bio, but it’s not a big deal, it’s just an annual reporting requirement that will now exempt single patient cell and gene therapy products because they have a highly controlled supply chain, the information is actually already reported so it would be redundant, and it’s not necessary to protect the public health. The FDA actually spells this out:

FDA has determined that applying the reporting requirements under section 510(j)(3)(A) of the FD&C Act to this category of biological products is not necessary to protect the public health.

Manufacturers of cell and gene therapy products, where one lot treats a single patient, maintain a highly controlled and secure supply chain from initial request for treatment of a patient to final product delivery to the site where the treatment occurs. This is because, due to the nature of these products, manufacturers implement strict chain of identity procedures to track products through the manufacturing process, to make sure the correct product gets to the correct patient. Additionally, the supply chains for these products are well-established and well-understood from information described in the BLA, and generally do not involve wholesale distributors, brokers, or other intermediaries.

Additionally, pursuant to §?600.81 (21 CFR 600.81), the Agency generally receives lot distribution reports every 6 months from BLA holders. Specifically, reports submitted to the Agency under §?600.81 include, among other information, the fill lot numbers for the total number of dosage units of each strength or potency distributed, the label lot number (if different from fill lot number), the number of doses in fill lot/label lot, and the date of release of fill lot/label lot for distribution. For this category of biological products, because one lot treats a single patient, the lot distribution reports submitted to the Agency under §?600.81 represent the amount of product manufactured for commercial distribution, and additional reporting of such information under section 510(j)(3)(A) of the FD&C Act would be redundant.

https://www.federalregister.gov/documents/2023/04/13/2023-07772/exemption-of-certain-categories-of-biological-products-from-certain-reporting-requirements-under-the