NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

Yes Northwest Bio has stated their intention to file for accelerated approval and should qualify for RMAT designation, so I think it’s highly likely that it has been considered, and may be used eventually. But why haven’t they applied or announced it yet? My point was that the reason may be that they are considering another accelerated approval route first.

DCVax should meet the criteria for an Innovation Passport but it may be too late in development. This is the relevant section of the guidance:

When to enter the pathway
The ILAP enables multiple entry points depending on:

* the stage of development of the product

* the data available

* the ambition of the applicant to engage with UK stakeholders

* the applicant’s appetite for new innovative ways of working

Therefore, the pathway will allow entry very early, based on non-clinical data, where all the tools described below might be options, as well as catering for products with mid-development ‘global’ dossiers. However, to maximise the benefits, applicants are encouraged to apply early in the development of their products. Products that are towards the end of their development programme are generally not suitable for the ILAP unless there are one or more indications still under active investigation.

The ILAP does not replace the Early Access to Medicines Scheme (EAMS), which remains an important flexibility for earlier patient access towards the end of the development programme in areas of unmet medical need and where major advantage over existing therapies can be demonstrated. The ILAP is broader in scope and is open to all innovative products.

Early pipeline discussions with developers are encouraged. These can be conducted with the MHRA and partners in the context of broader scope meetings, for example.

I think regulators understand that there will be a number of innovative treatments that are already in late-stage development when new guidelines were established that may deserve some flexibility on their eligibility. The MHRA, NICE and other stakeholders in the UK are well aware of DCVax, so it certainly would be worthwhile for Northwest Bio to apply.. An acceptance and rapid approval of an innovative treatment for Glioblastoma could be a public and political win for the MHRA and its new pathway as well. And actually the ILAP route would qualify for Project Orbis, which was included in the long list of the benefits of the ILAP that I included at the end of my post.