Replies to post #299657 on NorthWest Biotherapeutics Inc (NWBO)

[drugrunner]

lol alex---

this was a significant problem in tumor treatment in the 2000s

pseudoprogression was thought to be an issue --then just plain progression with monoclonal antibodies

ROCHE DRUG kadcyla initially had similar issues thought to be progression even though the patients looked and felt great..

tumors were eventually removed and re-examined and found to be hollow shells and effectively dead... what started as a dime or nickel sized tumor grew to quarter size and died..

but this took years to recognize-- kadcyla is now a billion dollar breast cancer drug..

so for our purposes... our progression or PSEUDOPROGRESSION can be explained but telling the difference in real time is very difficult

but those who argue that dcvax failed PFS...

KNOW THIS AND ARGUE AGAINST ITS EFFICACY

[exwannabe]

Never heard of pseudoprogression of course, never heard of SAP of coursz, never heard of the difficult path Yervoy ewperenced (was almost stopped in an early phase 3 phase).

I presume you are asserting I am ignoring these.

psPD is certainly real. And it very possibly could be the root cause of much of what has happened to this trial. And it could actually be a good thing wrt DCVax-L actually working (both AVII and myself pointed this out years ago). But if you do not think failing the primary endpoint is not a concern you do not understand the space at all.

I have known what a SAP was before it became the buzzword du jour in this caffe. I have actually taken the time to read and understand a few. They are fairly dry documents that detail numerical analysis of the endpoints. The actual endpoint should be in the protocol (though there is a lot of space for fuzz here).

I also know NWBO was talking non-stop of the SAP bu never said they actually submitted the IND modification. Sounds to me like they never did, and likely because the FDA warned them that a change this late would be viewed as post-hock and put the trial in danger.

You are right I never heard of Yervoy's difficulties in early phase 3. I do know that it entered the clinic after DCVax-L and was approved almost a decade ago. I guess I consider 9 years from entering the clinic to approval about normal.