Replies to post #435671 on NorthWest Biotherapeutics Inc (NWBO)

[Nick119]

Great post DMB2. Thanks for sharing.

[WLWeller]

DMB2,
I like your posture! Calm and well thought out.

Keep a finger on NWBO's pulse and continue
to give us your feedback on things!

A new fan!
WLWeller

[hoffmann6383]

Thanks for the post. Enjoyed reading it. I agree with everything here.

[antihama]

Doingmybest, good to hear from you...and your on the money posts! I, and other posters have argued over the years, that you don't need full manufacturing capacity to get regulatory approval but do need to show a plan for manufacturing expansion. Regarding

I think it is very doubtful they have submitted their BLA already, but, there very well could be some surprises here and they could have withheld communication on such an event if they are involved with new regulatory processes which they can state require confidentiality.

Yes, that may be a wild card regarding a stealth BLA but I don't think so. I would need a sign such as getting BTD like many other drugs that went through that pathway but you never know. Anyhows, again, it's good to hear from you.

[highwayman4life]

Great post DMB2!!

Quite the journey this has been for our "little train."

GLTA

[HappyLibrarian]

Hopefully Ms. Powers has progressed past the “All Big Pharma brings to the table is a checkbook” mentality.

While maintaining a plausible capacity for going it alone is a reasonable negotiating strategy, the reality is that you do not want to be like the Dwarf band of adventurers in The Hobbit who did not want to share out the great treasure with their neighbors. It is better to have 50% of huge riches now than to struggle another 5 years for 100% of it all, or if things when as they did for DNDN, 100 % of nothing.

Partnering (with real revenues not pay your own way) or accepting a buyout on reasonable terms is indeed what is best for NWBO shareholders and especially for GBM patients who actually do not have the time to live up to that name.

[The Danish Dude]

Thank you very much for you chiming in! :-)

[ilovetech]

dmb2, I couldn't agree with you more. IMO, Amarin is a perfect example of a failed GIA, despite surviving a history of small wins, only to be followed by monumental setbacks, which led to painful time horizon extensions. Unlike NWBO, Amarin "MET" all it's timelines, which includes DL, TLD, NEJM article, and a standing ovation at the AHA. However, Amarin failed miserably on everything that followed these achievements, because IMO, a small biotech is great at R&D and seeing the results through to publication, but not anywhere near suited to launch, grow sales, and certainly not in the same league as BP to defend patent challenges and infringement cases.

Something which is ever present, but not discussed enough: BP's control the FDA! The game is played in a way that protects this truth from becoming too scandalously obvious, otherwise their fiefdom would collapse. Their corruption is administered selectively, and where they forego their greed in the interest of maintaining an appearance of integrity (cough cough), is amply made up with by a few blockbuster drug franchises which drawf the revenue of all others combined.


If anyone would like to learn all the different ways a small one drug company can mistep their way to failure, look no further than Amarin.

So for all those who think their riches are sperated by a mere TLD announcement, they better be prepared to handle a falling knife at any time and for any unexpected, "seemly unfair" reason. Amarin had it's patents stolen to invalidation when challenged, because the Judge either doesn't understand how to read trial graphs and the difference between stat SIG and NOT on purpose, activism, or just ineptitude only, but it happened.

The courts are no less in a conspiratorial relationship with BP's, but again, on a selective transactional basis. The basis for all of these observations have been pouring out like the end of a firehouse since I fell in the rabbit hole over the last few years, and I wish I was wrong. But I'm not.



ILT

[exwannabe]

I have been away from this MB for some time...

You really did not miss much.

When you first showed up 6 years ago plenty of talk about the importance of spending on manufacturing while Direct sat on the bench for lack of funds.

The -L trial endgame was "soon", with talk of secret FDA BLA submissions and possible approvals in months.

And of course the raise at the end of 2015 being "one last raise before TLD".

[Maverick0408]

“There will most likely be slower approvals and platform development than hoped for, and, the best solution is for NWBO to partner asap. I think it is very doubtful they have submitted their BLA already“

Mostly agree with both your points. However, the age of the management and their experience suggests it will very likely be a buyout rather than partnership. I am not sure how long they want to continue at this age. It will be a long and challenging journey even with a partnership. Also, I am not sure if a big pharma investor (in case of a partnership) would trust the current NWBO management to execute in a timely fashion in the future (given the history) unless there is an agreement to bring new management. And in this case, why would the current management want to continue holding on to this much longer? The only reasonable explanation would be if they expect a much bigger pay day than what’s currently offered for a buyout.

Either way, regardless of how good a technology you have, if you don’t innovate, scale, and execute fast enough, competitors (new technologies) will catch up and you lose the edge. So I hope they do the right thing in the interest of patient community as soon as they get approvals.

[DavidW2]

Who are you? This is your first post.

Are you telling us another 1 or 2 months waiting time? Hopefully Q1? How do you know better offer from the journal? I don't think this is called "Quiet period". It doesn't make sense company can hold data for another 2 months because there is better OFFER for Journal? better OFFER from BP might be good reason.

Are you an insider?

Market could be face huge correction soon. I hope NWBO don't choose worst timing to report TLD.

[JRIII]

One possibility here about the publication is that a better offer from the journal was accepted to provide more highlight to the article and they agreed to wait another month or two to take advantage

You do realize that with the interim report they could not find a single respectable journal to publish it. They ended up having to pay to have the article published in the Journal of Translational Medicine or whatever it was called. They paid to have it published on short turnaround with no peer review.

To assume this delay is the result of their accepting a "better offer" for publication is beyond absurd. In fact, this whole wait has nothing to do with publication. How could anyone justify letting cancer patients die while they waited for just the right publication? Seriously? Why the hell can't they just release the TLD, or pay to have it published in the JTM again? Isn't the whole point of this to save patients' lives? This is so dumb, and anyone who believes the publication ruse is utterly delusional. The only possible explanation is that the data is not good and there is no publication willing to put this sham, with its post-facto endpoint changes and reliance on historical comparisons, in print.