Replies to post #94077 on NorthWest Biotherapeutics Inc (NWBO)

[Evaluate]

I am not sure if I am catching the drift from Flipper, but I think Flipper might be hinting at the idea that regulators might be requiring a confirmatory trial as it relates to approval of the Phase III trial ... and that the newly discovered phase II trial could perhaps be a confirmatory trial for a similar group of patients ... and with a shortened timeline for vaccine treatments. Flipper ... does this sound about right?

[highwayman4life]

Accelerated Approval
For many drugs and biologics that treat serious and life-threatening diseases, showing actual improvement for patients, such as living longer or feeling better, can take a very long time. Because of this, FDA created the Accelerated Approval regulation, which allows earlier approval of drugs and biologics based on a surrogate clinical endpoint.
Tumor progression and time to tumor shrinkage are examples of surrogate endpoints for oncology drugs. Using surrogate endpoints instead of clinical outcome data can significantly reduce the time required to receive marketing approval for your compound.
It is important to note that Accelerated Approval does not formally change your marketing application review time. Instead, it shortens the actual research time prior to approval (see Figure 1 below). For example, instead of two adequate and well-controlled studies, if you’re granted Accelerated Approval, you might only have to conduct one of these studies prior to FDA approval. It’s also important to note that if Accelerated Approval is granted, FDA requires a post-marketing commitment to study actual clinical outcomes.