Replies to post #421629 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

In my opinion David, that is a false and premature assumption.

The trial is different for exactly the reasons that the FDA is discussing in its current reform efforts, the issues with patients having too much at stake to join a trial with a true placebo, crossover and other challenges in terms of diagnosis of a difficult Illness for which technologies adapted over the time of this trial, particularly scanning, do not in my view suggest a trial with mediocre results, but rather a trial with what look like stellar results but some challenges based on the legacy of old rules that applied at the start of this trial and are in the process of being reformed not for this trial specifically but for all trials that are like this, many experienced after this trial started.

The issues are obvious to all involved including the regulators I believe, and the challenge is not having to require more of the company, when the results are obvious, simply because legacy rules got in the way. Everyone has done their best to maintain the freedom to adapt the trial because of these things, it appears to me, even to the point of maintaining the blinders until the data lock. The FDA moving early to reform the use of external placebo, etc.

I think, it is likely everyone will be bowled over by the results for a large percentage of the patients and impressed overall with the very substantial gain in survival on average as well.

But the challenge is also reforming it all and presenting the data, and I expect they even have a lot of other data using DCVax outside of the trial that they probably also want to use and can under new rules coming into existence shortly, but the regulatory agencies again are slow. They may decide to pull the trigger sooner, but the most ridiculous result would be NOT to wait for the regulations to catch up and to strand the treatment on the pyre of impatience, setting back care for all cancer patients but especially GBM patients, after a very long trial, much sacrifice, and incredible results. I think no one wants that outcome, even the regulators. I think validating Flaskworks will be incredibly important also to expediting approvals after results are announced. I think they are likely working on all of it with incredible and simultaneous energy, on all cylinders, on a shoe string budget. And someone wants to choke it off.

I think they will have a very compelling case to be made and it will be very exciting for the entire world to see it. I could of course be wrong. All IMHO.

So I see it very, very differently than you do.

[The Danish Dude]

If TLD meet primary endpoint and all other secondary endpoints, and if FDA agree OS as primary endpoint. NWBO doesn't need journal support and can just release TLD any time.

But NWBO went for a journal before data lock and before being unblinded. So it was a strategy call, rather than knowledge about the trial outcome.

The trial outcome came later and hence they convinced Kristyn Power under the guise of an NDA, that proved to her, the trial was good, so she quit her manager job in Deloitte and now manages NWBO Toronto, where she plays Minesweeper inbetween she prepares for the big showdown.

[hoffmann6383]

so many inaccuracies in this statement it's not even worth a response

[Hopeforthefuture3]

David, your scenario makes logical sense. If primary and secondary endpoints all a success then it is very logical to release tld asap and start work on a bla. Let the journal article come when ready and would imo be published faster as medical world would want to see the details on such a breakthrough as told from tld release. Those dismissing such logic can't (or won't) show any examples supporting their position.
Dave Innes reportedly compared the tld reported by CVM without a technical paper to nwbo and why they are waiting for a published paper. Well CVM released tld on a trial that failed the primary endpoint - I hope this is not a good comparison. The cvm trial did have ok results (good, not great) on a secondary endpoint. In such a case I can logically see the need for a paper.
Companies that have succesful primary and secondary results in my experience share that with the world. Look at AMRN when they completed results from their very large study with succesful primary and nearly all secondary endpoints announced tld and on that announcement to stock quadrupled in a day. Published paper and the detail came a few months later and is very impressive. That imo is how to share results from a successful trial. Amrn later lost it all back when they lost the patent trial - unfair result in my opinion.
In the meantime with nwbo we wait near 52 week lows, who knows what we will see today.
My covid vaccine stock NVAX on the other hand is (at least in premarket) up 90 points in the last 5 weeks now at 210 - was 120 when false rumor of manufacturing troubles was released by an 'anomous' source 5 weeks ago. Company quickly refused the false rumor - not afraid to protect themselves from false attacks.
Let's see examples from those criticizing your logic
BTW I still think nwbo will succeed on primary but your logic does make sense and I have no reasonable explanation why no tld
Good luck

[martyDg]

I agree with this possibility… A possibility that some here will always disagree and will call you short for this.