NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

Atl has been wrong a lot and just can't face facts

That's right—just as many other cult members have blindly dismissed critical issues. The DCVax-L trial is far from a slam dunk, primarily due to the lack of regulatory authority (RA) guidance on the use of external control arms (ECA) and real-world evidence (RWE) without access to individual patient data (IPD). That’s a major problem.

We should count ourselves lucky that the MHRA now appears willing to accommodate NWBO by initiating guidance, likely to create a framework that would allow DCVax-L to be approved. But let’s be clear: this has been a massive gamble, on top of the already speculative nature of biotech investing.

Unfortunately, there are very few voices on this board who demonstrate real understanding of regulatory affairs. And the cult-like enthusiasts are certainly not among them.