NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

It was discovered before data lock, and what they needed to get the data was collected from the beginning. The SAP update was not “ad hoc” legally or in any other way, and neither was the medical community’s change of the standard biomarkers denoting glioblastoma. That change was not made in reference to data mining this trial. That is not a factual allegation. It would be ridiculous if the FDA ignored this highly relevant update to the broad sciences now order to avoid asking NWBO and Dr. Liau the relevant scientific questions in the context of an approval for a new drug for Glioblastoma, as it is defined now. THAT would be “data mining”, not ad hoc, or after the fact, but a kind of willful blindness to help the company. I do not see the FDA doing that and clearly the company and Dr. Liau did not expect that kind of blindness either, and they spent the time and the money to get that IDH status for every patient.

You have the facts and the law backwards in this case.