NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

HyGro,

If you don’t like how the ECA was adapted into the trial, I recommend focusing on the DCVax-L trials that have a placebo design.

All of the most relevant context is missing from your curiously composed post, including the fact that the DCVax-L cell-based technology has been under clinical investigation for a significant period of time using internal controls too. The overall clinical data in total include three trials spanning many years. Safety and efficacy data have been gathered from both external controls and placebo controls. The data include DCVax-L as a monotherapy and in combination with other agents.

All data are relevant…

The reason clinical trials must be approved to commence and must be registered on the NIH registry is because all clinical data are relevant and no data pertaining to safety and efficacy can ever be unpublished or deleted from public view. We always must consider all of the data. For example, if a drug were found to be toxic in a certain patient population or in a certain combination with other agents or foods, those data could not be ignored just because they were collected in a separate study. Those data would have bearing on a regulatory application as well.

The PD1 combo trial is currently small but mighty. It is significant for a number of reasons relating to FDA guidelines and NIH peer-reviewed grant funding. It also follows the P3 in sequence which in itself is a fact that validates the findings of the P3 study—the placebo group in the PD1 study would not be receiving DCVax-L if the preceding P3 had not proven its efficacy.

Regarding the ECA/crossover design and the SAP, please review the video recording of Dr. Ashkan at ASCO 2022 and the JAMA Oncology podcast recording of Dr. Liau. Both recordings are included at the links below.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171254048

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171254756

Always do your own careful research to verify online postings.