Replies to post #514317 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Iron Mike,

If pseudoprogressors were found in the treatment group they shouldn't be removed from the trial, a determination of pseudoprogression is actually a sign the vaccine is working. If all in the treatment group were pseudoprogressing we'd probably be curing a lot of patients.

We really don't know at this point if our longest living patients were deemed to have progressed early in the trial, but actually had pseudoprogression, or not. Perhaps that's one of the things we'll learn once the Journal comes out.

I frankly don't know if today they can differentiate between progression and pseudoprogression without an invasive procedure, a needle biopsy may be sufficient, but I'm not certain of that. If it were adequate the question might be, do you make PFS part of the trial criteria or do you just stick with OS and allow the trial to take longer to achieve it.

Gary

[Hopeforthefuture3]

FeMike, imo that is why one of the secondary endpoints on the European sites is evaluating confirmed progression within the trial patients. From the data presented so far imo there is no way to say pfs was a succes. Now I agree we need more data but from slide #11 of the NYAS presentation 11% (26 of 232) of those on treatment did not progress vs 13% 13 of 99) of placebos. We need more data on pseudoprogressors to make a real determination but at this point can't claim pfs a success. For OS can claim a success
I am very interested to see all the data and seems to be taking a very long time
Hope they are working very very very hard
Pedal to the metal

Also wonder how large and long a task it is to complete a bla and similar for the UK and Europe. Remember the SAP was a 'ginormous' task and took a year or more