NorthWest Biotherapeutics Inc (NWBO)

[iclight]

Hoping the company’s bullshit redo of the trial gets around the FDAs REQUIREMENT of patient level data for the ECA isn’t just wishful thinking, it’s absurdity.

Medicenna got ACTUAL APPROVAL for their hybrid ECA (which includes a database with all patient level data) from the FDA because they actual met with the FDA after their P2 to confirm they could use an ECA. Do you think they would’ve chosen the more time-consuming and expensive route they chose with patient level data if the FDA didn’t require it? They would’ve done the same bullshit that NWBO.

But hey, that’s exactly why they didn’t submit to the FDA and submitted to the practically irrelevant MHRA.