Replies to post #183469 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Did she suggest the median endpoint failed? I missed that part...

She did not directly say/suggest such.

She did talk a lot about combo treatment and other treatment modalities before being asked about DCVax. She did talk a lot about median not being important (though as AVII77 correctly points out, that is a red herring as the FDA does not consider it important). And she does talk a lot about subgroups.

When asked about the DCVax trial she states that unfortunately the unblinding is up to the corporate sponsor, not investigators.

Then she starts to talk about some long term survivors who may have benefited, and some who did not. And it is important to know who did and who did not.

[flipper44]

In the lead up just before the DCVax-L conversation, uncanny similarities of a global example drug that didn't separate at median, didn't meet SS, but had 20% to 30% long tail. In such a scenario it turns out it was Dr. Liau that wanted such a trial to remain blinded for subtype research. Bemoaning pharmaceutical companies can't wait.

Clearly one could easily leap to perhaps such an exact conversation going on at ASCO, and LL given an out because she had an emergency.

Here is what does not make sense. If this was already a given by ASCO, why did UCLA give a new date for combination start only to pull it back off a week later? Why did Linda Powers still think she could have a frontline therapy at ASCO? Why did Dr. Ashkan basically say straight out at ASCO that DCVax works for everyone? Why did Dr. Bosch as recently as ASCO state it was still his hypothesis DCVax gave an advantage in both methylated and unmethylated?

Did the result come out today to LL and she ran to the microphone? Or, is there a distant, perhaps unreasonable hope, she just wanted to get ahead of the unblinding by freaking people out? Or do we sadly cling to the seemingly impossible hypothesis this is the "big long."

[longfellow95]

There is no such thing as a 'median endpoint.'