NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

sentiment _stocks, I agree with you. Also, in my opinion, I do not believe that the bears are reading past the first part of this section of the guidance. The second part of this guidance says the following:

If sponsors do not own the data used for the external control arm, they should structure their agreements with the data owners to ensure that patient-level data can be provided to FDA in support of the marketing application. Sponsors should also ensure that FDA has access to source documents and source data for the external control arm as part of an FDA inspection or upon request.

NWBio would not have direct access to the patient-level data because this data is owned by the Sponsors of these competing clinical trials. For proprietary reasons, and to potentially protect their IP, these Sponsors will not grant access to patient-level data to NWBio because they are a competitor or potential competitor, and these Sponsors were testing treatment options that would potentially compete with DCVax-L, such as: bevacizumab, rindopepimut, tumor-treating fields (TTF), ICT-107, etc.

However, because the FDA approved the IND and study protocol for all of these clinical trials, the FDA already has the right to access patient-level and raw data for all of these external control arms (ECAs) that NWBio used in both the nGBM and rGBM analysis.

Even though all of these other clinical trials failed (except for the TTF medical device Optune), the FDA already have the right to access patient-level and raw dataset. However, for confidentiality reasons, the FDA will not share this patient-level data with NWBio, but the FDA will use the patient-level data to validate the trial analysis results published by NWBio and Liau et al.