Replies to post #287739 on NorthWest Biotherapeutics Inc (NWBO)

[beartrap12]

Ex, you know why NWBO changed the SAP, but I’ll offer a short answer for others reading. Very little was known about immunotherapies when this trial started. They used the same endpoints as was used in chemo and radiation trials. The big difference is that chemo/rad kill cells quickly, both good and bad cells. So it appears to work, and gives cancer victims a few months, sometimes a year or more, depending on the cancer. But the cancer cells that were missed usually come back stronger than before. So if you’re running a chemo/rad trial, where the treatment burns or poisons cells and kills them very quickly, you want to end the trial quickly and get the data collected literally before the patients begin to relapse. Immunotherapy works more slowly and more naturally with the body, over weeks and months. Patients who have weak immune systems may not last long enough for the immunotherapy to prolong their lives. So median progression free survival may not reflect as well on the strength of immunotherapies as it did with chemo/rad.
And then there’s pseudoprogression, where the infiltration of immune cells to the tumor site look like new tumor growth on a scan.
Thanks to Dr. Liau, Dr. Prins and other researchers in the field, we now know a lot about immunotherapies and how to determine if they work. We now understand pseudoprogression and how to identify it. I believe Dr. Liau has found bio markers that tell her if DCVax is working. The new SAP gives us better tools to measure the effectiveness of DCVaxL. In addition, they are setting the standard for analyzing other trials of L and Direct that will follow.
We may likely have the same or similar endpoints, but we’ll have better tools to measure the outcomes.

[marzan]

why do they have to modify the SAP? Let me tell you Ex which you already know. The old SAP was designed based on the old obsolete chemo timelines. The simple answer is to reflect the big fat tail they are suspecting in the actual data to com out in July. In other words, to account for the non-proportional hazard they think is happening in the actual k-m curve. The previous SAP was based on the proportional hazard. Basically Ex, they have to modify the SAP to account for Everyone is Living Longer. Oh you get even more nervous now, don't you? Get it? I know you know the answer even before anybody else in this board know it, but I m sure you are pretending you don't know or you don't want to tell the truth. Simply challenging 'why do we have to modify the SAP if we are sure about the endpoints' might look smart but is simply a FUD you know that. We know the endpoints are still good but we have modified the SAP to reflect the path in arriving this endpoint. No big deal for some and yes big deal for a lot of others. For all, like once biosect or kabu said TLD will speak for itself. SAP is not everything but TLD is everything. Another nervous thing for you; like PFS has to be adjudicated, SAP has to be modified to follow the trends in mmunotherapy. Where is AVII. He is a conscious man that he left this board long ago. How many more days you are going to be with us? One cannot keep on fooling others for ever. I bet numbered now.