Thanks for sharing your expert opinion and your level of confidence about this! I have no relevant experience in the area of RA activity. I do know that LP has always asserted that they have good relations with the FDA and while she may not have any prior experience with getting FDA approval, she and LG both have very extensive experience as Washington lawyers and I believe they have been active in getting the FDA to understand the need for a better approach to GBM as LL and her UCLA colleagues have been vocal about quite recently. It's not possible to miss that. LG may have even more direct past experience in this area of regulation than Linda, I'm not aware of all the details of his DC law practice but he did tell me he has been in DC since he arrived there to take a position in the Carter administration.
DI has long expressed confidence that the UK wants to improve from being far behind the US in adopting new oncology treatments and with Dr. Ashkan being very highly regarded, they might be even more eager to allow this to go forward. In turn, there would be no way that US patients and their oncologists and neurosurgeons would be inclined to accept having their patients continue to need to go across the pond to get this treatment in the UK.
Personally, I have no idea what the actual programs and procedures for expedited approval are nor what the parameters are but it seems clear that the clinicians and patients are going to want this very badly. I'm sorry that NWBO and their advisors decided to wait for the journal article before giving us TLD but obviously they had reasons for encouraging the wait and that is not a decision that Les and Linda would have made without their experts not concurring or taking the lead in pushing them in that direction. While it's been frustrating to still be waiting as the stock fell or got pushed down this far, it's hard to imagine that this is not going to bust a major move in early 2022 first based on positive tld being released and then hopefully on a positive surprise on how quickly they can move this to regulatory approval - how soon the latter might come I personally wouldn't know but patients are literally dying waiting for this and lots of people know that.
