Replies to post #758766 on NorthWest Biotherapeutics Inc (NWBO)

[antihama]

Here's to our opinions. GLTU ATLnsider cause if you are having good luck, me thinks I'll have good luck too.

GLTA Longs

[skitahoe]

When the trial began, the cross over was mandated, but after pseudoprogression was clear, the trial had to  be modified or abandoned.  Fortunately all four regulatorsop agreed on how the trial could continue. 
I don't know that today a new trial could be conducted with a PFS goal and be able to differentiate between progression and pseudoprogression.
Gary 

[ilovetech]

ATL - I'm not as organized as you, as I don't have the specific LL speaking engagement filed by date, but I recall her speaking on this. She spoke about enrollment challenges, and how patients didn't want to end up in the placebo arm. So you take two steps forward and one step back due to drop outs. Keep in mind, these are very sick late stage patients, who are physically, mentally, and emotionally having a tough time keeping it together to begin with. So the enrollment period gets interrupted over an extended period. The trial design is highly interactive with the FDA. It involves strong interactions BTW both parties. The FDA offers guidance as opposed to mandating, however, with severe disease and ethical reasons, ultimately the decision is made through bilateral negotiations, and not for example, unilaterally made by the sponsor.