NorthWest Biotherapeutics Inc (NWBO)

[anders2211]

h2r, I have done a lot of reading, studying and I have spoken and emailed with an SEC lawyer back in November and a biotech PR company on the subject you mention. For months I had many discussions both here and on the Anavex board. My background, Im a lawyer however not licensed in the US but in The NL so not a lawyer in any US state : )

So if its ok with you I will just give you the summarized version of what I have read and learned over that period of time.
First, your question is can a biotech company from an SEC point of view just sit on positive results, isn't it material, should they not disclose this as soon as they learn about it. The answer is NO a biotech in that position is not required to do so immediately. One could argue that the information is something the average investor would very much like to be disclosed as soon as the company learns about it and something that would move the stock price, but no.

The biotech company is allowed to first build the case, the underlying evidence of data why the topline is positive before releasing the summarized version of the data we call topline.

In other words, NWBO is allowed to first have the publication-ready before releasing topline data.

If you are interested a good resource Iis:
https://scholarship.law.edu/cgi/viewcontent.cgi?article=1016&context=jchlp
Predictable Materiality: A Need for Common Criteria Governing
the Disclosure of Clinical T e of Clinical Trial Results b rial Results by Publicity-T y Publicity-Traded
Pharmaceutical Companies

Then vice versa, as soon as the company learns that the data is in such way that it will most likely NOT trigger FDA drug approval in a phase 3 drug trial, in other words, the P3 trial outcome is negative. Then this information is material and should be disclosed within 4 days. In this case, the biotech company can not linger until it has built the underlying data case with for example an article in a journal.

On the Anavex board someone asked me but what if they never release positive topline data? I answered that such has never happened before and the FDA has a rule where it's stipulated that after one year of primary completion date the results should be submitted... we have talked about that extensively here as well..

Now I will probably get all kinds of remarks on this post. But since I have spent days and hours on the subject both here and on the Anavex board Im not going into further discussion. I hope my post has helped you to get an answer.