NorthWest Biotherapeutics Inc (NWBO)

[Diamondjim61]

Very nice Flip. Love this post.

Afford, years ago, yes years, I thought NWBO (back then I kind of thought LP), would be faced with a very very difficult decision. That is, if the primary endpoint succeeded early on, would they or would they not unblind the trial and cross everyone over. Let me add something to that which makes the decision to share even more complex. Even if they shared results on PFS early on, were granted AA and kept OS blinded, the patients in the trial would have been demanding crossover, left for israel, Germany (or just bought on the market in US) or basically tried to find someway to make certain they were getting DCVax-L instead of placebo (who would blame them?). By the way, I think NWBO's answer to this was placing critical information soley in the hands of the CRO (and DMC), keeping interim analysis quiet (or perhaps not even done) and FOCUS ON THE OVERALL LONGEVITY in the trial and crossover. That way they could justify trying to keep the trial going to achieve OS statistics as well. Got that? That's the rosiest perspective you'll ever read regarding this trial. IMHO.

Now, in this year, I believe we are past that point. There is no reason to protect placebos from crossing over if data is released, because in my opinion there are no placebos that have not crossed over. Got that? That's the rosiest perspective you'll read. I happen to believe my rosy perspectives are very likely. Yet that's my personal viewpoint.

If we are now at that point, why not just release the data? Guess what, they are in the process of doing that according to their PRs and Dr. Bosch's and Dr. Liaus' statements about what would drive data lock. Got that? I believe they are extremely close to data lock. That's as rosy of a perspective as you are going to get. IMHO.

Now, if you read my posts lately, I said Doc Logic had the quote of the year, where basically he intimated NWBO was likely told not to crack a smile from here on out until results were released. Did you know the FDA hates, loathes and despises leaks of blinded data and even hates companies saying they basically think they have Statistical Significance in the bag before unblinding. Celldex did that just before their results failed. It's even worse if your results succeed, because then the FDA is wondering if the investigator was not really blinded and might question the integrity of the trial and might call for a whole new trial. IMHO.

Thus, you haven't been getting a peep, except their indirect reference to other people's guesses in Dr. Bosch's last presentation. In other words, they are positive but not suggesting they know the results. In fact, Dr. Bosch has clearly pointed out Investigators and patients are still blinded. IMHO.

What was your question?

Oh yeah....

Quote:So Flip if things look s so good why is mgmt acting like it isn't by not closing the books on the trials and publications of results. Please answer this question because it is completely opposite of what you are claiming to be true. -- Afford



This is all my admittedly biased opinion.