They ALL involved novel devices, biologics and SMDs, but you know that already, since that's what clinical stage bios are about. I guess some involved label extensions or new indications for already approved drugs. Basically all had shoe string budgets, many were global trials, etc. Not everything about NWBO's situation is unique. For sure, the length of time, the crossover issue, the FDA's recent guidance on use of historical controls and other matters relevant to NWBO, the developing science in immunotherapy, those are unique, as is the GBM target in general and attempting to become the standard of care. But all clinical stage bios have their challenges and unique issues.
I will say though, that none of the issues that you identified as unique to NWBO caused NWBO to file 37 late SEC filings (and to make poor disclosures in pretty much all of their filings) or to lose their S-3 eligibility. None of those issues caused Les Goldman to go onto the Big Biz Show and make a fool of himself. None of those issues caused the company to tell investors they would have TLD in September (before the database was even locked). Now, here we are, almost 7 months after data lock, and the company's official line is they are waiting to release TLD until they get a journal article published, or until they have a commitment to publish. I can't believe anyone believes this, frankly.
As if they would skip ASCO because they are waiting on anything having to do with a scientific journal article. Yet a bunch of seemingly very educated and intelligent people believe this statement, despite management's history of either intentionally misleading investors or gross incompetence.
I don't pretend to know what the delay is about with respect to the release of TLD. As I've said many times now, my best guess is that it has something to do with some kind of ongoing discussion with the FDA. Hopefully the timing has worked out so they can get an LBA presented at ASCO.
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