NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

muee88, I had a chance to go back and review one of the links you posted back on 5/13/2021:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=163787757

Your message post was about the NWBio "quiet period". Some on this message board insist that this "quiet period" is a made-up, self-imposed, invention by NWBio, and it was created by NWBio to hurt NWBO investors, and to delay or hide information about the outcome of the DCVax-L Phase III clinical trial.

However, your link was an excerpt from the book, titled "Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk". Chapter 4 in this book is titled: "The Clinical Trial Life Cycle and When to Share Data".

This book was written by the National Academy of Science, and this book is available on the National Library of Medicine (NLM) at the National Institutes of Health (NIH) website here:

https://www.ncbi.nlm.nih.gov/books/NBK269030/

As we all know, the NLM at the NIH is the same federal government agency that maintains the US clinicaltrials .org website:

https://clinicaltrials.gov/ct2/about-site/background

The NLM at the NIH also enforces the rules that govern when the clinicaltrials website should be updated by pharmaceutical / biotech companies (Sponsors), and Principal Investigators (PIs) who are conducting clinical trials in the US. The NIH enforces when clinical trial endpoints should be changed or updated on the clinicaltrials website, and they also enforce rules regarding when Sponsors and PIs should update the clinicaltrials .org website with the clinical trial results.

Here are some quotes from chapter 4 in the NLM NIH book, regarding the "quiet period" and the important and necessary reasons for Sponsors & PIs havings a "quiet period":

https://www.ncbi.nlm.nih.gov/books/NBK286004/

Similarly, sponsors should have a “quiet period” of a reasonable length to allow for the regulatory process of seeking approval for a new product or indication. Giving too much weight to the interests of secondary users and competitor sponsors in gaining access to data would in the long run present strong disincentives for clinical trialists to design and carry out future trials and for sponsors and their investors to develop and test new products and indications.

Given regulatory agencies' broad perspective on the data, their public health mandate, and their accountability as government agencies, the committee believes, as noted earlier, that it is beneficial to allow regulators a “quiet period” as they carry out their review, during which clinical trial data need not be shared with other secondary users, even beyond the 18-month period after study completion.

Conclusion: It is beneficial to allow a “quiet period” while a product or indication is undergoing development for a regulatory application during which the full analyzable data set and metadata need not be shared unless the data are published.

This should put to rest all the arguments and complaints about the "quiet period".

Coincidently (or maybe not), 18 months from October 2020 (DCVax-L Phase III clinical trial data lock date) is this current month, February 2022.