Replies to post #761384 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

Got it, thanks.

[exwannabe]

Quick math note.

As MHRA has no overdue MAAs per their timeclock, and NWBO's is something like 370-420 calendar days (depending when the clock started) since verification, does that not imply a clock stop time in the range of 160-210 days?

[skitahoe]

I don't know that you're correct about an RFI being a material event.   I don't believe the company ever announced having even one.  I also believe that while 60 days is allowed to answer an RFI, it can be a very minor event answered in a day or two.
I believe that they have had numerous such discussions that could be formally be called RFI and they often are resolved very quickly. 

We'll really never know what has been discussed, but hopefully what they learn in working with the UK results in making the submissions to other regulators much improved. 
Over the years I have learned that many things thought to be material events by investors aren't by the company.   In many cases, even monetary payments are ignored if below levels the company decided is routine, of course they show them in the financial reports.
Gary 

[manibiotech]

If I remember right , MHRA guidelines said that they only issue at the most two official RFIs . But they can unofficially of course ask for more info.

[Doc logic]

dennisdave,

The current situation seems more like requests for clarification rather than for new or missing info which would be part of a formal RFI letter. There are only 1 or 2 formal RFI periods described by guidance. Informal requests for clarification seem like the normal path for any approval process. Best wishes.