Replies to post #525361 on NorthWest Biotherapeutics Inc (NWBO)

[newman2021]

HyGro, f the FDA. Who cares! The heart that still beats is all that counts.

[hoffmann6383]

Bullshit. No other way around it.

Here is the actual language from the RISK FACTOR SECTION regarding confoundment and anything 'post hoc':

Under the Protocol the primary endpoint was progression free survival, or PFS, and the secondary endpoint was overall survival, or OS. Both of these endpoints were confounded: the PFS endpoint by pseudo-progression, and the OS endpoint by the “crossover” provision in the trial design, which allowed all of the patients in the trial to cross over to DCVax-L treatment after tumor recurrence (while remaining blinded as to which treatment they received before tumor recurrence). The statistical analysis plan uses external control patients rather than within-study controls.

The confoundment for OS was simply from the cross over. Otherwise, there is no confoundment when counting beating hearts.

Second, as seen above, nothing was 'post hoc' as alleged. NWBO was blinded while changes were made.

This narrative is not based on facts but rather, counter to facts.

[Dr Bala]

A confounded post.