NorthWest Biotherapeutics Inc (NWBO)

[10baggerz]

This is the type of information sharing that makes an investment forum valuable.

As opposed to people shouting the same extremes and unfounded positions at each other. The FACT is that the MAA for DCVAX for GBM/rGBM with artisanal manufacturing ONLY is neither DEAD ON ARRIVAL nor is IT GUARANTEED WITH A CHANCE OF EXPANSION TO TUMOR AGNOSTIC + FLASKWORKS.

I own 2.5 million so I acknowledge my own bias of leaning towards approval.

While I still believe that approval is more likely than not Dr Liau’s statement below is acknowledges a POSSIBLE reason for this extended regulatory delay. What if the RFI(s) related NWBO to providing either patient level data or providing real world data based ECA?

This would certainly explain;
1)THE EXTREMELY LONG DELAY
2)THE LACK OF APPROVAL
3) THE LACK OF REJECTION
4) THE LACK OF A DISCLOSURE OF A MATERIAL ADVERSE EVENT
5) THE DISCLOSURES THAT NWBO REMAINS ACTIVELY ENGAGED WITH THE MHRA
6) THE FACT THAT NWBO IS SKIPPING EVENTS LIKE ASCO TO FOCUS ON APPROVAL
7) THE FACT THAT NWBO DOES NOT APPEAR TO BE ABLE TO START THE NICE REIMBURSEMENT EVIDENTIARY PROCESS
8) THE FACT THAT THE MHRA SAYS THE MAA IS NOT PART OF THE BACKLOG
9) NWBO NEEDING TO BE COMPLETELY SILENT AS TO THE MAA

LL:
“However, we were unable to obtain individual patient level data from the previously published comparator trials so we're not able to do individual patient matching which we are all aware is a current limitation with the use of external controls, so I'm actually hoping that our publication and the discussions around, it will spur the sponsors of these clinical trials to publicly release their individual patient data so that we as a field can further innovate and get regulatory interest in the use of external control arms in neurology and oncology trials.”