NorthWest Biotherapeutics Inc (NWBO)

[MI Dendream]

Pseudoprogression may be the answer as to why NWBO needed to provide additional information after the decision to continue was made. It answers the question of why you would continue the treatment regimen even after the primary endpoint at the time was reached in an individual patient. Had they stopped treatment in those patients, then you would have a classic crossover design trial, but they didn’t because that would be unethical to do to those patients.

If there are fingers to be pointed as to why this has taken so dang long, those fingers should probably be pointed at FDA. I am certain LP spoke with FDA when they chose to go past 248 progressions, 233 deaths, before they published in JTM, and before taking almost two years to lock the database. They could have verbally given guarantees but obviously they did not.