Replies to post #736354 on NorthWest Biotherapeutics Inc (NWBO)

[XMaster2023]

HyGro is being paid to lie. He knows it’s a lie but his objective is to mislead new investors so they believe the trial failed. Doc I know you know this but the new investors are trying to figure out if DCVax-L really works. My only advice is to read the JAMA Journal Article. It definitely works according to the 73 Coauthors. Unfortunately like many things in life, NWBO started out in one direction (PFS) and they ended up taking the longer path (OS). Do your due diligence, DCVax-L works.

[exwannabe]

Progression-free Survival (PFS) was an INITIAL endpoint ...

PFS was the primary endpoint and used in the 2015 efficacy IA. Had it been a success they would have submitted for approval based on it many years ago. But the trial failed to establish the endpoint and the reason does not matter.

Only after that did they change the endpoint. And doing so after an efficacy analysis is a cardinal sin in trials. Sure, they can blame the change on whatever. But any RA is going to seriously question if the change was influenced by the failure of the IA. Does anybody really believe they would have changed if it had worked in 2015?

There is no question OS is a better clinical metric. But that does not change the fact that it was not until after the trial had failed the primary PFS in 2015 did they change it.

BTW, on a related note longs might wonder how the company provided data from P1/2 trials that showed a 24 month PFS vs the under 7 months in the P3. Does not matter now, but kid of sounds like they were more interested in cooking numbers in the P1/2 than actually trying to find best how to run the P3.

Oh, we can queue the "PFS does not matter" responses. Replying in advance, the primary endpoint at time of the .first efficacy analysis matters a hell of lot, regardless what it is.

[HyGro]

Dr. Liau chose PFS as the primary endpoint in the SPORE/UCLA trial so the technology is clearly valid or she wouldn't use it again. Clearly she believes in PFS as her primary endpoint. For DCVax-L trial her interim analysis made it obvious that DCVax-L was NOT going to meet the primary endpoint. NWBO's future (and Dr. Liau's) was absolutely dependent on meeting the endpoint and they were desperate. Two weeks before the end of the they totally redid the trial protocol -- new endpoint, new trial arm, new comparator.

It's the facts.