NorthWest Biotherapeutics Inc (NWBO)

[br8k0ut]

Cures Act implications for DCVAX direct if DCVAX-L is approved...

The provision under drug development section subtitle C ->

Enables drug manufacturers to submit real-world evidence (RWE) instead of randomized control trial (RCT) data to seek new indications for existing medications. RWE is clinical practice and utilization data collected outside of the RCT setting and is regarded for its comprehensive patient
perspective under circumstances that reflect real-life experiences. Under the Cures Act, permissible sources of RWE
include ongoing surveillance data, observational studies, registries, claims, and patient-centered outcomes research activities. he costs to generate RWE for the approval of new indications will be substantially lower than the costs for traditional RCT evidence generation. Thus, manufacturers are positioned to achieve higher returns on investments when their overhead is reduced by observational studies.

https://pubmed.ncbi.nlm.nih.gov/29952706/

So according to the law, if DCVAX-L is approved and is efficacious, new indications like DCvax direct can be submitted for approval without the need for long phased RCT clinical trials because They could just use the successful data from L trials as well as whatever data is collected after it is in use. I think we could see approval for DCvax direct within 1 to 2 years.