Replies to post #608786 on NorthWest Biotherapeutics Inc (NWBO)

[Dr Bala]

The JAMA article and the FDA Oncology group guidance in the 2022 AOO article are in sync and now constitute a dull topic. Please post on the INDIGO trial with some stats. Also a post on low glioma competition might generate some discussion. Thanks so much, HyGro.

[hoffmann6383]

reading from the boilerplate risk factor section again? I'm talking about the SAP, which had been approved. This boilerplate risk factor section speaks to approval of DCVax-L, not the SAP. Your argument doesn't logically flow.

Have a good one Gro!

[biosectinvestor]

Risk factor sections are just like those long drug warnings that cover everything including death. The purpose of them is to be as broad as possible about every possible thing that could ever go wrong, and often years before there might even be a hint that there is risk, the purpose being that under the law, if a person reads or hears such things and then proceeds, for instance in taking that drug, then they've contractually "assumed the risk" willingly, and there is not liability.

However, risk factor sections are not predictions or statements about what WILL happen to you or what HAS happened to you, they are just broad catch alls. This has been explained to you numerous times here by me and others.

Further, we know the company explicitly said they would not unblind until all 4 regulators accepted their updates and, in fact, we know that the EMA for instance, approved it because they control the listing for the clinical trial which indicates the endpoints and all of the relevant information to confirm approval.

Further, the FDA is the company's primary regulator. It's doubtful that the EMA would agree to something if the FDA had not. They are independent agencies sure, but the trial originated in the US. The global trial is ONE TRIAL. They are not going to agree to change such a standard and then have it be different in the US, for the same trial. Regulators are not that dumb.

https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001977-13/DE

Main objective of the trial
The primary objective of this study is to compare overall survival (OS) between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in patients with newly diagnosed glioblastoma. This endpoint will be assessed using 3 different analyses.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=158800616

I just got off the phone with the clinical trial regulation department EMA.

She confirmed that NO changes to clinicaltrialsregister.eu can be made directly by the sponsor. She told me that indeed only approved changes such as endpoints are submitted to the clinicaltrialsregister.eu IF the national health organizations in the specific countries have allowed and approved such.

In the case of NWBO she confirmed that this has been recently done so.
Also, she confirmed that in the case of NWBO this has been done so by the NHS in the UK and PIE in Germany.

https://classic.clinicaltrials.gov/ct2/show/NCT00045968

Primary Outcome Measures :
The primary objective of this study is to compare overall survival (OS) between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in newly diagnosed glioblastoma. [ Time Frame: Until death ]

Secondary Outcome Measures :
The first secondary objective is to compare overall survival (OS) between patients randomized to placebo who received DCVax-L treatment following disease recurrence, and control patients from comparable, contemporaneous clinical trials, in recurrent GBM. [ Time Frame: Until death ]