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Re: Doc logic post# 770535

Thursday, 06/05/2025 5:07:06 PM

Thursday, June 05, 2025 5:07:06 PM

Post# of 824214

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.
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