NorthWest Biotherapeutics Inc (NWBO)

[MolBiol]

SEC regulations on disclosure:

Koman, I think your second paragraph was directed squarely at me.

If anyone has any doubts about where the DMC decision is reported on the 8-k just take a look at the ICPT 8-k from January 10th (I believe that was the date). The decision is very clearly reported in section 8 item 8.01. I don't know who you spoke with at the SEC but they either didn't understand what you were asking or maybe you are confused about what they told you. The SEC guidelines on what is material is loose and vague and clearly big pharma companies know where to report DMC decisions. And that is in section 8; Item 8.01.

Furthermore, I can't even find any SEC form for Gilead when they stopped their trial of Idelalisib early in Oct 2013. Section 8 is where optional disclosures are reported and GILD I guess decided it isn't even necessary to report the DMC's decision formally to the SEC.


Furthermore, here is a link to a law firm review of what goes on the 8-k:

http://www.mofo.com/files/Uploads/Images/FAQ-Form-8-K.pdf

Also, here is another link to a story in the New York Times about corporate disclosure:

http://dealbook.nytimes.com/2011/04/05/in-corporate-disclosure-a-murky-definition-of-material/?_php=true&_type=blogs&_r=0


"and now I know why that poster deleted his message."

And most importantly, I didn't delete anything. The post was removed by the moderator for what reason I have no clue. I had no notice and no way to challenge the decision. I assumed that you complained because I was a little blunt in how I wrote at the beginning.

So yes, I believe I am right and there is no need for me to correct myself. I am a professional. I have a PhD in Molecular Biology. I've worked in my field for 15 years, worked in industry wearing many hats including regulatory affairs where I wrote sections on adventitious agents, cell substrate qualification studies and upstream process development to support submission of a BLA. I've sat face to face with the FDA to defend the parts that I wrote. Therefore I do know a little bit about bringing a new drug through the approval process.