Replies to post #566428 on NorthWest Biotherapeutics Inc (NWBO)

[CrashOverride]

Bravo, per usual.

[Doc logic]

ATLnsider,

I like the patient level data with regard to heartbeats in an indication where basically nothing else has been validated to work as well as DCVax-L, especially when ancillary evidence is dropped into the BLA in support of trial results. Best wishes.

[exwannabe]

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.

The only patient level data the FDA would posses in the ECAs is the Optune trial, as that was submitted in the PMA (Pre-Market Authorization). The other trials never submitted BLA/NDAs so the data would never have been provided.

That the FDA approved the trials to run does not mean that they can go back a decade later and demand sponsors (or whomever) collect and provide the individual patient full records.

And on the Optune data, that is proprietary data, per law.

Glad you understand that this is actually an issue though.

[sentiment_stocks]

Good to know. :)