Replies to post #778176 on NorthWest Biotherapeutics Inc (NWBO)

[seekinganswers]

Odd that Kevin Duffy is not mentioned on the company website or yahoo finance "executives" page.
Hmm

[Idunno]

Impressive. ... 

[beartrap12]

Dr. Andrew, thanks again for your take on my Dr. Duffy /Winterfell timeline and how it meshes exactly with everything happening with DCVax-L , Advent, and Flaskworks' EDEN. I was looking for any holes in my theory and so far, we haven't found one.
My theory: When Dr. Duffy was hired away from Merck in September, 2019, was he actually setting up a collaboration between Merck and NWBO that would result in the construction by Merck of its WP50 vaccine building (Project Winterfell)? Read Dr. Andrew's last long post on Winterfell to learn how this building potentially would by used by Merck to aid NWBO in the distribution of DCVax-L and adjuvants in North America.
As longs know, Dr. Duffy left and went back to Merck a year late and when no deal materialized with NWBO, well, we were disappointed.
But maybe some type of collaboration did happen. Dr. Andrew's timeline on the design and construction of WP50 begins immediately, in 2020 at West Point, PA., and I gather it's completed or almost completed now.
This obviously is still all conjecture because we've heard nothing from the company about a Merck collaboration, but based on facts that many here have assembled, it appears to be a conjecture with legs to stand tall on.
Is it possible we'll get an announcement after approval in the UK (IMO though obviously I expect approval to happen!) about some kind of partnership with Merck??? I think so.

To me, the big question was: Can a public company hold back such a big secret from its shareholders for 5 years?

Dr. Caravello's answer:

Could a deal exist but not be disclosed? Yes. And legally, it’s normal. Under SEC Rule 405 and Form 8-K, companies are only required to disclose material definitive agreements that affect revenue, asset control, or shareholder risk. But if the deal is conditional, pre-commercial, or non-binding until approval, there is no disclosure requirement. Many partnerships begin quietly, especially in biologics. Infrastructure can be harmonized years before launch. It happens all the time.

I may have more to add about the legalities soon.
Thanks again, Dr. Andrew

[Idunno]

It's been, interesting, watching them try to bury your impressive post. Very busy, but sloppy, bees this Sunday. Thanks for your post. Thanks, Beartrap, as well. 

[ilovetech]

This observation is 🔐 IMHO

It was not designed to produce millions of identical vials. It was designed to receive cryopreserved therapies, match them with patient-specific boosters, serialize and label per batch, and dispatch under GMP. That matches DCVax, not any known product in Merck’s public pipeline.

[meirluc]

"Under this framework, tissue can be shipped into the UK, processed regionally using Eden, and returned to Advent for fill, finish, and QP release. Final vials can then be distributed back to the clinic for injection, completely legally, so long as batch records are traceable and the process is controlled by the licensed Control Site. That is how more than 600 patients have already received DCVax under the Specials framework. And that is how the first wave of real-world deployment will scale in the UK and EU"

Where are the records for the substantial amount of money that paid for the
treatment of 600 specials and where would that enormous sum of money end
up? As far as I know there are no records that indicate that NWBO gained a
substantial amount of money from the specials nor is it possible that the company
would have been able to bankroll the treatment of 600 patients


It is however possible that NWBO/Advent received just enough dough to cover the
treatment expenses.

I am also curious to know how many of those 600 were diagnosed with non GBM types of
cancer.

[beartrap12]

Slave, another note on the Dr. Kevin Duffy time with NWBO...or more accurately on the time he left.

To go back in history first, very long Longs, do you remember the Neil Woodford debacle?

Here's the PR:

BETHESDA, MD, October 21, 2015 – Northwest Biotherapeutics (NASDAQ: NWBO) (“NW Bio”), a U.S. biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that the Company has entered into agreement for funding of $30 million from Woodford Investment Management in the UK (“Woodford”).
Woodford will purchase $30 million of the Company’s common stock at $5.50 per share, for a total of 5,454,545 shares, raising Woodford’s total holdings to 25,915,937 shares, or about 28.1% of the Company.  The purchase will take place in a closing on or before October 22, 2015.
NW Bio also announced that it has engaged Ondra Partners (www.ondra.com), a London-based corporate finance firm with a focus on value creation and an integrated approach to medium and long term financing and related initiatives.
In connection with this financing, the Company has issued 0.7 million shares to Cognate BioServices on the same terms as Woodford’s stock purchase, for certain current payment obligations, as well as completing the issuance of shares to Cognate that were approved and reported in November 2014, but had not yet been issued.
“NW Bio has reported encouraging interim clinical data from both its DCVax-L and DCVax-Direct clinical programs, both last spring and recently, with patient survival exceeding expectations.  With this new funding from Woodford we look forward to moving these clinical programs ahead vigorously while continuing to build our organization” commented Linda Powers, CEO of NW Bio.

We thought he was the golden Prince that would finance us and bring us out of obscurity and into the big bucks. We didn't know a lady named Wolf was a trojan horse from Ondra Partners (who Woodford suggested to management), entering our company right through the front door. Not until Linda caught her sneaking a look at documents that she had no business looking at did management realize what her true purpose was. Turned out, she was trying to gain info against NWBO and, I believe Cognate, not for a partnership, but maybe a take over by Woodford.
The claws came out, the gang circled, and Linda began a battle that eventually wiped out Woodford and his bio fund companies. Literally. I remember the bad blood between them and Linda was not afraid to talk about it (As I remember. I attended that ASM that year.)

Run forward in time to Dr. Duffy's arrival fresh from Merck in September, 2019. The company announced his hire by PR, quietly said little to nothing while he was with us, then had nothing but praises of his work with us after he left and returned to Merck a year later.
When it became obvious there was no deal with Merck in the near future, I actually wondered if management had let another wolf in the front door, and wondered if time would prove that Merck ripped us off. I believe others thought the same.
But wind forward to today...now it appears that management's positive opinion of Duffy after he left should have been a clue, a big clue that something had come out of his time here after all, a deal that wasn't entirely finalized, I'm guessing, an agreement based on "ifs: if we bring our product to approval, perhaps.
I think the contrast between these two shows that Linda always, ALWAYS protected and protects DCVax. It should have been a clue!!

[attilathehunt]

And once DCVax receives U.S. regulatory clearance, whether through BLA, Accelerated Approval, or Orbis-linked authorization, WP50 becomes the natural Control Site for the United States

Merck is taking 2 huge leaps of faith....

1). DCVax-L gets approved in the United States and in short order and
2). NWBO will make a deal with them

It seems like a lot of capital being deployed for something that is not a guarantee....UNLESS......

If the UNLESS is solidified and then once made public, forget the $1 or $2 share price, it will be like $30 overnight! A stock halt lasting almost the entire day....Too bad we can't short the Hedge Funds!! Hope DJT doesn't think about bailing them out. Let them burn!

[exwannabe]

And once DCVax receives U.S. regulatory clearance, whether through BLA, Accelerated Approval, or Orbis-linked authorization, WP50 becomes the natural Control Site for the United States and possibly broader international jurisdictions. It does not need to replace Advent. It needs to complement it.

FDA requires a BLA to be submitted. It requires the BLA to be approved.

That "certain" longs argue this point is funny.