Replies to post #421992 on NorthWest Biotherapeutics Inc (NWBO)

[Dr Bala]

Excellent stuff. Thanks, Flip.

[flipper44]

Imo.

[Basin Street Blues]

Very good. Thanks Flip

[Kaizenman]

flipper44: Thank you for documenting and sharing this event history!

[The Danish Dude]

Awesome recap/explanation Flip!!!

[ATLnsider]

Very nice recap and summary flipper44.

[br8k0ut]

"Sometime this month or early next month, Advent in Sawston will, IMO, receive gmp certification to make DCVax-l (at an initial pace of 45 batches per month.)"

Will flaskworks eventually double, triple, or even quadruple that 45 batches per month? Trying to grasp the potential impact that flaskworks will eventually have. Any ideas?

[MalteseFalcon]

Sometime in the coming weeks/months NWBO will launch several trials on other solid tumor cancers using DCVax-Direct

Sometime in the coming weeks/months NWBO stock will be uplisted

Sometime in the coming weeks/months NWBO will do a reverse split

Sometime in the coming weeks/months NWBO will raise capital to fund the above mentioned trials

[Chiugray]

Flipper thanks for that great encapsulation of what has happened and your very appreciated opinion on what are the upcoming events to look forward to.

I have never felt so strongly that we are now on the cusp of a major turning.

[reachjo]

Now that’s a history lesson! Great work.

[sukus]

Excellent post. Thanks Flipper.

[Truthfan]

Truly appreciate this recent and most excellent post.

[blue_skies]

THANK YOU

For taking the time to put the summary together.

I hope "in the coming months" is before the end of Q1 20222?!

[Mionaer1]

Outstanding.

[Sojourner55]

Excellent post Flipper. Nice recap and summary.

[Doc logic]

flipper44,

And during that same time many of those seeking to imply bad things about NWBO or their directors had problems of their own. The ex CEO of Cenkos, friend of Mr. Neil Woodford, unceremoniously disappeared from his position after a run in with NWBO Director and investor recruitor Dr Navid Malik. Ms Katherine Wolf, Ondra Partners full partner and overly interested party in all things NWBO confidential, was called out, had the notes she took returned but apparently not until Mt. Woodford or his fund managers had a peek. She unceremoniously left Ondra after being stripped of her partner status and Mr. Woodford was stripped of his duties with the fund he ran later on which was subsequently liquidated driving NWBO share price down with it, he being thus distanced perhaps so that he would not go to jail for trading on non public information about NWBO.
All this combined with a trial that fully enrolled all treatment patients but was deliberately left under enrolled by regulators, with 17 missing SOC/placebo patients, who then had to point the finger at NWBO in order to lift the hold when they agreed not to enroll any more patients which subsequently led to the first sign of production ramp up that you mention.
Yes flipper44, the picture becomes much clearer when the pixels are brought closer together ; ). Best wishes.

[DavidW2]

"By September 2020, the DCVax-l trial endpoints had been changed and/or reorganized to prioritize external controls. It maintained its original primary endpoints as secondary. The new endpoints potentially allow consideration of rGBM in addition to nGBM."

Where is the PR to talk about this? Please provide the link. Thanks.

[biosectinvestor]

Fantastic history Flipper! I don’t agree on every point, but as a historical piece it’s excellent.

[j e d]

nice recap, but imo your timeline is so off as to create another setup for disappointment. Sawston may well take until late January, publication + TLD could take until March or April, and approval might now happen until fall 2022 or sometime 2023. I have high confidence that things will play out as we expect, but I think it will take significantly longer than the timeline you’ve painted here.

I only say this so that when Jan/Feb rolls around with no big updates, there’s not another collective sense of dismay when in fact things are still going according to the (very slow but sure) plan.

[MI Dendream]

Flip thank you for that condensed and clearly laid out history of major milestone events. Sometimes it is quite enlightening to see the forest while trying to organize the trees in ones mind.

I would say that while the pace may be slow, add in all the details we know of data and patents and financings and skullduggery etc, etc, etc and you can see a ship that has been steered with a skeleton crew not just competently but expertly through high seas and tropical storms and is arriving at its destination with its cargo intact and its bounty of fish even larger.

Thank you for your leadership among the rag tag band of militia men and women who have fought bravely and passionately awaiting that vessel. Victory is at hand my friend and the spoils will be bountiful!

[erik007tc]

Wow, thank you!

[aperture007]

As usually, great post Filpp. I'm glad you're on our side!

[hoffmann6383]

Nice timeline Flipper

[CaptainObvious]

Being ready to go as close to speed as possible will allow NWBO to fully capitalize on their patents as soon as the clock starts ticking upon approval of DCVax(x)

[xoma4578]

Great post Flipper.

Stick this post to the top.

[eagle8]

Thank you flipper.
Great post.

GLTU

[hope4patients]

Excellent post. Thanks for the historical refresher!

[learningcurve2020]

And none of that can effectively be PR'd to avoid selling all their shares at all time lows?

You're basically saying they stalled out for five years of saving lives because of something that cost less than $2 million to develop?? Even with an army of smart h5 technicians under U.S. / UK supervision, somehow couldn't produce DCVAX "affordably" without the $1.4M gadget?

Pseudo progression has been an issue for decades. Any patient and good doctor knows when a tumor is in remission vs. growing. So, how convenient Flaskworks and the new progression detection methods theory moves along all at the same time.

Not buying any of it. Just Google GBM survivors over the last ten years and you'll find a sea of people doing well on all types of treatments, of which DCVAX rarely appears.

[exwannabe]

Large swaths of time are difficult to internalize

But easy to rationalize.

Sometime this month or early next month, Advent in Sawston will, IMO, receive gmp certification to make DCVax-l (at an initial pace of 45 batches per month.)

Possible, but I would bet late Q1 based on LPs pushing expected reply to EOY and still need turnaround time at MHRA.

BTW, NWBO has never said an initial capacity of 45/month. One should always read LP's PRs very carefully.

Sometime in the coming days/weeks, imo, a journal article will announce topline results for the DCVa-l trial and explain those results in depth.

"Weeks" has been asserted since over a year and a half. "Months" has been asserted for 5 years.

Sometime in the coming weeks/months, DCVax-l will be approved for GBM

Based on the old "secret BLA" theory, the "bag" or what?

[iwasadiver]

Bravo Flipper

[newman2021]

flipper, isn't the new definition of GBM by WHO 100% captures only the IDH wild type which is I think the mesenchymal subgroup where the JTM 2018 paper showed great benefits? Isn't the same subgroup that LP commented that the FDA effectiveness guidance should support?? Thanks for sharing your knowledge with us. Knowledge is Power!

[barnstormer]

Very nice Flipper. Hopefully we'll see something soon.

[voloda69]

In 2017 Linda renamed Cognate to Advent. She knew already…

advent
/'adv(?)nt,'adv?nt/
noun
1. the arrival of a notable person or thing
2. the first season of the Church year, leading up to Christmas and including the four preceding Sundays.