Replies to post #403026 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

The FDA/EMA will look at the raw data to validate it vastly more than a journal peer review would

The journal will not get the raw data, only results as presented by the sponsor. The FDA/EMA will get the raw data. They will repeat the full stat analysis. They will perform additional stat work that will not even be in the plan.

Here is a good example of how pathetic journal peer review is compared to FDA/EMA review.

In the 2011-2013 time frame DCTH complete a P3 for Chemostat (a system for injecting super high dose chemo into the liver blood supply and filtering it out before it could cause systemic adverse events).

The trial data looked solid. They had a SPA with the FDA that the primary endpoint of (liver) PFS would be good enough. It easily hit that endpoint. OS was shaky, but that was not needed for approval (and they had the crossover excuse).

The FDA slammed them. Why? Because turned out that some of the manufactured devices were killing people, and DCTH did not know why.

Where this goes comical is that they had a paper on the trial published in 2016. It asserted that chemoStat was safe. And the peer review team allowed that despite knowing that the FDA (with access to the raw data) saw that it was not.

How could a peer review possibly accept a conclusion with :

The toxicities associated with CS-PHP are in most cases transient and manageable

when they should have known the FDA had already trashed the NDA submission because they saw it was not safe?

[Gus McCrae]

For what it's worth, I now believe that they are waiting to release TLD until the journal article has been accepted for publication (or published, whatever). The reason I believe this is because there is no other reasonable explanation for the delay at this point.