NorthWest Biotherapeutics Inc (NWBO)

[tunnelvisionofplenty]

I don't give credence to things I can't verify myself unless the source has proven to be highly trustworthy, so I personally do not put much stock in those reports. Also, even if it were the case that some kind of activity related to inspections were taking place in January, I don't think that would have prevented the second CHM meeting from occurring in December. The consistency of the 6-month gap between CHM meetings 1 and 2, along with the variable amount of time between CHM meeting 2 and approval, indicates to me that the date of the second meeting is set based on a statutory timeline rather than being held after the conclusion of the second phase of review of the MAA. That is, if a second meeting is necessary then it will be held 6 months after the first meeting, regardless of how much work is left to do.

Approximately 3 weeks post-CHM meeting #2 seems to be minimum amount of time to hear approval news. For medicines that take longer, sometimes a 3rd CHM meeting happens, while other times it does not. Sometimes it takes less time (like 5-ish weeks post CHM #2), while other times it can take many months (up to 6 months post-CHM #2 at the absolute longest). To me, this indicates that whatever happens post-CHM meeting 2 depends on the nuances of each application. But the evidence also suggests that, regardless of what happens post-CHM meeting 2, that 6-month gap is consistent. So unless and until other tangible evidence emerges, that's what I personally feel more comfortable basing my opinions on.