Today's Submission to National Comprehensive Cancer Network (NCCN)
Dear fellow NWBO shareholders:
The verbatim text of my submission appears below, between rows of asterisks.
My message was submitted via Submissions@nccn.org, which is what in an earlier post I referred to as NCCN's public suggestion box. Documents attached to the email included meeting abstracts and a press release. (No peer-reviewed journal article. Sore subject.)
By the way, last month I received a personal email from the chairman of the NCCN's central nervous sytem (CNS) panel. He is a professor of neuro-oncology at the University of Alabama in Birmingham, and he assured me that autologous tumor lysate-loaded dendritic cell vaccination "will be included in the next review." FYI, these NCCN guideline panels meet at least annually and more often if needed. The CNS panel's next scheduled review (according to info posted on the NCCN website) will be in October.
-- OncoJock
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July 23, 2022
Dear NCCN:
This message comes in response to your June 1 request for revisions and more information.
I would like to respectfully request that autologous tumor lysate-loaded dendritic cell vaccination be added as a treatment option on page GLIO-3 of the NCCN practice guidelines for newly diagnosed glioblastoma patients.
I would also like to respectfully request that autologous tumor lysate-loaded dendritic cell vaccination be added as a treatment option on page GLIO-5 of the NCCN practice guidelines for patients with recurrent glioblastoma.
As you have requested, reference materials in the public domain are attached. The Liau abstract was presented in Prague, Czech Republic, during a July meeting of the Society of University Neurosurgeons. The Ashkan abstract was presented in Liverpool, England during a June meeting of the British Neuro-Oncology Society meeting. The Mulholland slides (submitted earlier) were presented at ASCO in Chicago in June.
The additional treatment options requested above are not yet approved by the US Food and Drug Administration. A company press release explaining the current regulatory status for this product is also attached. Some of the regulatory terms may not be familiar to you, since NCCN is located in the United States and this product is advancing through a new regulatory framework set up in 2021 by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), the rough equivalent of the US FDA. For example, the MHRA’s Innovative Licensing and Access Pathway (ILAP) was created in 2021. My understanding is that the ILAP is meant to bring products to market in the UK more quickly.
Please let me know if I can provide you with any more helpful information.
Thank you for consideration of this submission.
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AI
