Replies to post #770535 on NorthWest Biotherapeutics Inc (NWBO)

[iclight]

Bullshit. Medicenna has a database of patient level data for their GBM trial. The FDA told them they needed it when THEY ACTUALLY MET WITH THEM in the P3 design phase, not after p3 failure.

It’s on the company to provide it as evidenced by the company’s inability to submit a BLA because the control is not only bullshit, but incomplete bullshit.

[exwannabe]

If FDA or any regulator wants patient level data they can get it for comparison purposes because they have the authority to retrieve it even though NWBO doesn’t

Really?

For the FDA I know of no such authority to demand data from trials already completed. Yes,. if the trial is in progress the FDA can demand the data, but we are talking trials from over 10 years ago.

The FDA does have the patient data from the NVCR trial as that was submitted for approval. But by law that is confidential to the sponsor.