NorthWest Biotherapeutics Inc (NWBO)

[AVII77]

I take it Hodag has got the right version of the Act.
And that there hasn't been any successor regulations.

I am not an expert on legislative matters. (though I remember those cartoons about how a bill becomes a law). I believe this is the most recent and correct Act that is awaiting signature. There are others (linked on that page) but this is the only one that shows the president is next. So, please confirm for yourself my interpretation.

https://www.congress.gov/bill/115th-congress/senate-bill/204/text

The text I copied is from that Act and the reference to the CFR I copied is correct (dealing with cost recovery).

I would be very interested to know precisely what the rules are, for companies, in terms of publicity related to RTT. Whether a company can publically invite RTT applications for example, or circulate an information sheet to all N.O.'s in the US. Or PR cases of successful treatments provided under RTT.

I believe the publicity issue is covered in the Act as it references and requires compliance with Section 312.7

§ 312.7 Promotion of investigational drugs.
(a)Promotion of an investigational new drug. A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug. This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media. Rather, its intent is to restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution.

So interpret that as you see fit. Amarin has recently won a First Amendment case that is slightly relevant.

I do find it curious how this board has suddenly had a lot of posts avowing that NWBO cannot possibly benefit from RTT...

What is that all about, do you think?

Well, I don't see how RTT would benefit NWBO (Cognate yes, but NWBO no). This is in contrast, I think, to what LP apparently indicated at the SH meeting (didn't someone report LP said RTT could be big for NWBO or game changing or something like that?).

After reading the actual Act (assuming we are looking at the correct one) and cited regs do you see how NWBO could possibly benefit from RTT?