Replies to post #626861 on NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

NWBio has been very very busy during the past year. This is contrary to what the manipulative FUDsters are saying and have been saying. 👍

[Survivor2012]

Great summary flipper44!! Can you post on FB, LinkedIn, X and reddit?!

[Margin Buu]

Great summary, Flipper. Thanks! Exciting times ahead.

[learningcurve2020]

Means zero.

1. They are in active negotiations with other companies regarding combination trials.

They had years to get all this right waiting for OS for years.

2. They have completed each and every precondition to filing an MAA.

ANTICIPATE

3. They anticipate submitting an MAA in late September to early October.

Great for private Advent

4. Advent have all manufacturing licenses for clinical, specials and commercial cellular manufacturing.

Great for Advent.

5. Their manufacturing capacity has increased with the latest expansion.

Eye rolls. A broke company up against...

6. They have responded to the motion to dismiss by crushing defendants’ arguments, including but not limited to pointing out the defendants, as their prior argument, have complacently relied upon overturned precedent.

2040.

7. They intend on expanding DCVax-l use to all solid tumors.

Yawn.

8. Meanwhile, the FDA announced final guidance for real world evidence usage in the approval process.

More eye rolls.

9. And newsflash, as TDD just posted, the Feds intend to increase their efforts against
Illegal shorting over the next few months, particularly related to hedge funds using articles in coordination with shorting. The Feds also intend to continue their efforts against spoofing.

[jon_k84]

Would it be possible for a moderator to sticky this? Excellent "state of the union" summary by flipper. A lot of new visitors likely to come in here soon and would be excellent if this was pinned at the top.

[hope4patients]

Things are about to get interesting. ;)

[CrashOverride]

BUY NOW OR CRY LATER!

[Doc logic]

flipper44,

I hear a crescendo building and the shorts don’t have any more legal shares to borrow. Time to release the hounds methinks; ). Best wishes.

[Zadie420]

Thanks flipper 44 for excellent points. These are really exciting times we are experiencing. Shorts/criminals cannot keep the lid on the boiling pot anymore.
I would like to direct your attention to something you said long, long time ago regarding increasing efficiency of DCVAX-L if doctors reduce the Chemo dosages or decreasing the amount of time a patient is on Chemotherapy. I wished someone would have follow this to see how DCVAX-L behaves. All the numbers documented so far and presented to MHRA are based on old technology/concept. The doctors know now when they need to apply DCVAX-L to get maximum efficiency from this treatment.

[aperture007]

As usual, another outstanding post by flipper!

I'm so glad you're back posting on a regular basis.

Good luck to all NWBO longs.

[HappyLibrarian]

Thought you’d find this interesting:

[Mionaer1]

Excellent summary. Thanks Flipper.

[OncoJock]

Flipper44, I respectfully disagree with you on one of these points that are now stickied at the top of our board.

Here is the actual language, cut and pasted verbatim from the most recent 10-Q:

The Company is in active discussions in regard to certain combination treatment regimens, and is planning for certain strategic trials with such combination treatments.

In your first bullet point, you have jumped to the conclusion that these discussions involve "other companies." Maybe, maybe not. It's possible that NW Bio is discussing these combo trials with UCLA, or a patient advocacy organization, or with the NCI, or with some other entity that is not a company.

Admittedly, the idea of NW Bio discussing combo trials with another company (such as Merck, Regeneron, Bristol, or fill in the blank ______) is a whole lot more bullish than if the other entity is a non-profit organization.

The more I learn about NW Bio management, the less I trust them, and the more I see the possibility that they have put just enough info out here for us (retail) to get our hopes up. Call me suspicious, but I think if they really are holding discussions with other companies, then that's what they should have said in the 10-Q.

Also, FWIW, in my day job of writing about the latest and greatest cancer medicines, it's highly unusual for a company to issue a press release announcing its intention to file a regulatory submission. In my experience, it's far more normal for a company to announce that an application has been accepted by a regulatory authority. Here's why: Just because NW Bio submits the application, doesn't mean the MHRA accepts it. The MHRA may require all kinds of additional info from NW Bio before it deems the application to have been submitted in a full and satisfactory manner. This may easily take a great deal of extra time, which of course no one is including in their timelines for a possible regulatory decision.

For this reason, I wonder if perhaps NW Bio management announced its intentions in this way as a tactic to gain the advantage somehow in its spoofing lawsuit against Citadel et al. Perhaps this announcement is more for the trial judge's benefit, than it is for the shareholders' benefit (though the share price has increased nicely since then and I'm not complaining).

Let's just say, for the sake of talk, that NW Bio submits an application for the MAA on Oct. 1, but MHRA, on close inspection, decides the application is incomplete. Will we be told that by NW Bio in a press release? I highly doubt it. It seems at least possible that, if the application is deemed incomplete and the MHRA requests more info, that it could take several months for NW Bio to come up with the required information. Only then would the 150-day clock referred to in the press release begin to tick, which would of course delay any decision by MHRA well beyond the May 2024 time frame that many people on this board are hoping for when we do the math. I guess this is another good reason not to hold our breath.

Don't get me wrong. I'm glad you're bullish, and I hope you're right. But there's also the possibility that you're reading too much into the 10-Q, there really are no active discussions about combo trials with Big Pharma, and the timeline for a decision by MHRA could be months and months past the May-June 2024 time frame we're all hoping for.

Best of luck to you,

--OJ

[HyGro]

NWBO has no cash for more trials - barely meeting payroll. Didn't participate in the NIH/UCLA SPORE GBM Combo trial with Keytruda the leading treatment to partner with. If they don't get FDA approval they are toast as MHRA UK approval is not enough revenue to survive on.

[Doktornolittle]

One of the elements of coordinated bashing is the posting of old to very old negative sounding news in Chrome search results for today's news. I don't know if Fierce Biotech and the other participants pay Google for this convenient error... (or whether the hedge funds pay it)... but this needs to be looked at. Recall that back when you (and I) were new here, there was a grand master for all this, a lead man who has now moved out of scrutiny. But let his history not be forgotten and let his present and recent past be scrutinized for less visible connections. And I am not talking about AF but rather a man with a much darker history including much clearer ties to hedge funds, including his own, and currently positioned at the highest pulpit in the land for retail manipulation.

[skitahoe]

Flipper, this is a wonderful post that is stickied, but I believe it would be more valuable if you updated it and a revised version replaced this.

Gary