NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

It would also explain some awkward moments. Like when Les was grilled at a presentation by a guy wanting to know proprietary information. Or like when AF had to be told by Dr. Pazdur, on stage, that some information in trials might lead to exposing proprietary information -- and therefore complete transparency was not always feasible. Or it might explain why NWBO never followed up with explaining what the screening hold was for, even though it is resolved. Proprietary information might explain all that. The requirement to protect novelty as it develops might explain all that.

Continuing this conversation with myself, it works both ways as well. Not only does NWBO have to worry about exposing new trial data prematurely (and getting in trouble with the FDA) by prematurely printing it in patent applications, but they have to worry about sharing it with the public prematurely, before it gets properly defined in the patent application. Normally the latter is not too difficult, because it goes from date of filing, which occurred a couple years back, but the problem, as I see it would be the fluidity of biological patents and the realtime insights and observations that must be then incorporated into the patent application post filing. Damned if you do, damned if you don't. So you'd try to get all these observations rolled into a simultaneous event upon which you achieve in a scientific publication. Again showing novelty of adding (possible) optimization. Thereby bypassing FDA wrath, SEC rancor, and satisfying Patent Office requirements.

Just thinking this through. Those two new optimization patent applications and the single arm publication might go hand in hand. Especially, if RK, Doc, myself and a few others here and there are correct that there may have been a mid trial improvement with DCVax-L.

In other words, the potential improvement (perhaps even halt of trial for efficacy in Germany) and publication, would show not only the public, but the patent office that the optimization (if it was incorporated in Germany) meets the definition of a new or improved invention. I mean, good golly, if "time release" can meet that....

Quote:
One means of extending patent protection for a commercially successful drug is to obtain additional patents covering new formulations of the known compound clinically superior to the previous drug formulation. Developing and patenting new formulations that promote patient compliance through reduced dosing or ease of use, or that exhibit improved therapeutic outcomes or more favorable side-effect profiles, is particularly advantageous for defending against generics and protecting market share. Moreover, new formulations, as long as being sufficiently similar to the original approved drug, have the additional advantage of a shorter Food and Drug Administration FDA approval route.

Examples include sustained-release formulations of existing drugs. When Lilly faced the expiration of its patent for the blockbuster antidepressant drug Prozac, the company developed and obtained patent protection and FDA approval for a once-weekly, sustained-release Fluoxetine formulation. Bristol-Myers Squibb also obtained patent protection and FDA approval for its extended-release formulation of the diabetes drug Glucophage (Metformin hydrochloride). Marketed under the brand name Glucophage XR, this new formulation permits once-daily dosing for type II diabetics.[8]


I think my head has danced around this notion before, but with those two patent applications still being active, I'd say this fits NWBO's M.O.

Remember Dr. Bosch saying (for Direct that is) Method A was only partially potent whereas method B was more potent? I think you might hear the same exact comment from NWBO/UCLA with regard to before Germany, and after Germany. The publication likely to be critical, and now it dawns on me, because I only vaguely understand patent approvals, that Doc may be right there might have been more optimization than just TFF. Doc thinks it has something to do with cell selection chip technology developed by Fraunhofer. Anyway, if this whole hypothesis is correct, the publication would, imho, be very important for the patent office. JMHO. -- flip