Replies to post #450140 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Thanks Diver,

If that was the case, are you thinking that clinical trials in the U.S. wouldn't need to be updated prior to the Journal as it's not so much a U.S. based publication.

Regardless of what Journal is used, publication will clearly mark the end of the quiet period unless the company has some new reason. The Journal should tell us all we want to know clinically, but I doubt it will address the FlaskWorks unit, or submissions to the regulators.

If the company were to reveal discussions were ongoing with potential partners, that too could be cause for a quiet period. I do expect the TLD statement would come out with the Journal, though the Journal would be far more comprehensive, I still think they'd issue it.

Gary

[pqr]

Tx diver. We all just received The Answer.

[skitahoe]

Thanks Diver,

I certainly agree with all you're saying. As to the possibility that Annals of Oncology is our target, rather than NEJM or Lancet, you've made a great case for why that would make sense. I'll be thrilled to have the publication in any respected journal. The key is getting the story out, just where isn't of that great a concern as long as it's a reputable publication, not somewhere that you can submit to, pay a fee, and they'll publish anything you wish.

I see overall survival as the real proof that any therapeutic targeting a deadly disease is effective. What's sad is that the company felt they had to take the trial so long to convince the regulators they've achieved a breakthrough. GBM is so deadly that once all patients had been dosed for 2 or 3 years it should have been sufficient. I don't doubt that their intention was getting all past 5 years, but by the time all 4 regulators agreed on everything we were at 6 years, and today we could provide data for all those still alive at 7 years or more. Clearly had the company known what they do today before the trial was started they'd have made OS the goal, and perhaps it could have been accessed when all were past say a 3 year goal. FDA trials are often based on a substantial number of events occurring, events are a polite way the FDA has of saying deaths. Sadly they don't seem to care that a trial is taking many years because events just aren't happening very quickly. Rather than saying something great has to be happening here, they wait for the events to prove it. If we accept historical information as the goals, why not look at the data once all enrolled patients have passed the median survival period established for the disease being treated in the trial. In the case of GBM, if I remember correctly median survival is less than 2 years.

In reality, I would hope that with historical data, something under median survival could be used for slow growing cancers, like prostate. I've had senior relatives discovered with it where the Doctors simply decided to monitor it as it was unlikely the cancer would reduce the patients life at all. I certainly don't know how it all could work, but something that reduced the time in trials, and permitted all who volunteered for them got the experimental treatment, no placebos, would certainly be a step in the right direction.

Gary