I am on vacation with family attending places that require tickets and exhaust you. So I am not reading this message board or replies to my avatar.
I understand that a similar tote from a previous (2018) SNO was reported here. IMO there are two very big differences between then and now. First, the registered trademark symbol is missing from 2018. Second, NWBO had an active trial open in 2018 and they do not anymore as of 10.5.2020. Before anyone jumps on the UCLA combo trial, it is just that a trial sponsored by LL and the UCLA, not NWBO. There are no active US trials sponsored by NWBO..
Also, regulatory scrutiny over premarket practices dramatically increases once you initiate the process towards approval. If the BLA is rolling, my opinion would be that started when the database was locked. If this is a more standard submission, then it may be that nothing at all has been filed and fear of reprisal remains low.
A question for Senti and others…if DCVax-l (or its alternative name DCVax) is a platform technology and not a vaccine drug therapy, then what exactly is the drug? It seems to me that each individual batch is unique, so it can’t be at the batch level or that would require 6.5 billion BLAs to treat everyone on this earth or 325 million BLAs if we focus on the US market. Not sure how you would test efficacy in each of those, or recover a fee for delivery of the product. Recall also that the ABTA ad says Brain Tumor on the page so, I believe that clarifies which version of the process they are referring to when they call themselves an immune therapy. To laymen, lung cancer is lung cancer it does not matter what cell type and brain tumors are brain tumors.
I have a lot of angst about all of this too. As with all legal arguments, it is subject to interpretation. But unlike most legal situations, it is not a judge or jury of peers that decides. It is FDA.
Now, I must go and may not read a single post until Sunday evening.
