Replies to post #606845 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

If you don’t like the ECA or other aspects of the landmark P3, then you have other DCVax-L clinical trials to consider.

What trials?

ATL-DC vs ATL-DC + PolyICLC? That would show that PolyICLC works when used in addition to ATL-DC, not that ATL-DC works.

ATL-DC vs ATL-DC + Keytruda? That would show that Keytruda works when used in addition to ATL-DC.

DCVax-L has been studied in placebo trials too if you like internally controlled trials.

DCVax-L has been compared to placebo in exactly one trial. And placebo lived longer.

[iclight]

If you don’t like the ECA or other aspects of the landmark P3, then you have other DCVax-L clinical trials to consider.

I don't need to like the ECA. The FDA needs to, IF the company ever submits anything. But they won't since the data is garbage except in NWBO fantasy land.

One thing we know about the FDA is they want to discuss with the company before an ECA is used, just as Medicenna did. And based on that meeting, the FDA also indicated they want an ECA combined with an internal control arm. This is a hybrid ECA as agreed upon for Medicenna's upcoming rGBM P3. And in those discussions, the FDA made it clear that they need patient level data in the ECA.

You're welcome.