NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

I am not discussing any arm. The FDA allows for expanded access when patients themselves apply. Kat and other patients have been given that access. I believe you are incorrect. They would need to have had disclosure because they are paying for their treatment. They are therefore not a part of a trial. In Kat's case, she applied from the UK and now receives her treatments in the UK, though initially she flew here. There is no way in hell the FDA would allow that without full disclosure. She just recently received a treatment and posted it. No way in hell.

Kat received her first DCVax-L treatment late in 2016. They were waiting at the end of April 2016 for the vaccine and as of March 17, 2016, they were waiting on the FDA's review. These are not perfunctory decisions. You don't just get approved because you ask. At the very least, if a trial has previously failed or had a futility determination, or had high risk, I'm sure the FDA would require full disclosure. But I feel that it's more likely that the application, especially a cross-border application, would not likely be approved in those circumstances But at least it would have required a full disclosure of such events. I can't imagine that that would not have happened. And I suspect Kat was not the only one getting the vaccine during the course of that period. But even if she were, again, I can't see it happening without disclosure at the very least of the kinds of events shorts suggest.