NorthWest Biotherapeutics Inc (NWBO)

[HappyLibrarian]

Tossing out primary endpoint that failed when a trial is virtually complete is very suspect for ANY trial. Ya think the FDA has seen every failed trial be spun into something that looks good. They will not look kindly on NWBO's protocol spin.

Ordinarily you would be right but Optune while better than nothing, does not provide enough benefits and SOC is a sick joke.

There will be a lot of pressure to not put off the chance of an effective treatment by another decade. Think about the approval FDA did for Alzheimer’s despite significant doubts.

While it is a technical fail that we should not gloss over, it is still worth noting that PFS is meant to be a surrogate for OS to shorten the length of the trial. NWBO already had to pay a penalty in time for switching to OS because DCVax-L was too effective and patients took too long to event and do the trial went on and on (good for the individuals but bad for getting the trial done and getting life extension to more patients years earlier).

Being a bureaucrat myself I can assure you that we are willing to make things happen fast in exigency circumstances and ignore technicalities are very good at dressing it up with the best of paperwork.

Could regulators fail DCVax-L? Yes it’s a 5 to 10 percent chance (this factors in conspiracy theories about BP and regulatory capture.

But will they?

No, I am going with the 90% to 95% chance.