NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Extending to new indications includes cancer in other organs. The 21st Century Cures Act is intended to expedite that process. You have heard that Keytruda applies to biomarkers, though that is not from the benefits of the 21st Century Cures Act. They have that kind of approval. And they have then validated in different organs with additional studies. But insurance will be expected to still cover based generally on various guidelines set forth now under regulations and off-label prescription, some shortly or recently to have become the rule. With immunotherapies, we’re in a different paradigm. The 21st Century Cures Act is intended to simplify all of the regulatory rules of the FDA further, with regard to the extension of the benefits of new drugs to new and relevant indications, which I explained previously. The FDA has numerous new guidelines and pending changes to implement the relatively new paradigm/law and DCVax will benefit from the new rules.