Replies to post #774099 on NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

Well to that effect even MHRAs new guidelines also prefer patient level data . So there we are . Not sure what the management was thinking all these years . 

[manibiotech]

And without any credible plans to apply to FDA you can forget about any of those lofty SP projections from usual few here in my opinion . Probably fraction of that . 

[ATLnsider]

Hopeforthefuture3, this is very common misconception, and often repeated Bear narrative.

Regulators (FDA, MHRA, EMA, etc.) only ask for or require patient-level data when an external control arm (ECA) is based upon real world data (RWD) or real world evidence (RWE).:

https://www.fda.gov/media/171667/download




As you may know, NWBio used an External Control Arm (ECA) to analyze and review the DCVax-L Phase III clinical trial results, but they did not use any RWD or RWE.

Instead, NWBio used pooled control group data from other concurrent and contemporaneous, peer-reviewed and published, randomized control trials (RCTs), to build its ECA.

All of the INDs for these RCTs were reviewed and approved by each of the regulators (FDA, EMA, MHRA, etc,) in the countries where these trials were conducted, and these regulators have access to all of the patient-level data, and the right to ask each Sponsor to provide all of these patient-level data:

[Investor082]

A lawsuit is coming this fall, just wait and watch!

[dennisdave]

Dennis, I still hope that at some time they may be able to obtain patient level data in the future, perhaps from the GBM agile program.

But at least for now FDA requires patient level data for comparison

I dont think that is going to happen because companies such as NovoCure that should then be delivering their IPD will not be indirectly assisting NWBO in the demise of their device Optune. As I said, I think NWBO will never request approval in the US, but the company buying NWBO will launch a new trial based on tumor shrinkage.