Replies to post #772144 on NorthWest Biotherapeutics Inc (NWBO)

[DJPele]

I pray that you are incorrect.

[skitahoe]

If I remember correctly, CHM have schedules established for what they're reviewing. I don't believe any such review has been scheduled. If I'm wrong, let me know.

I don't doubt that the company and regulators have had substantial communications. I believe the regulators do intend to approve, so the question is, what are they approving. Have the discussions been about expanding the label, or have they been about the EDEN, or strictly an approval for GBM alone. Are they requiring a confirmational trial, and could it be the protocol for that trial that's taking so long.

If I were NWBO, I would want to be permitted the addition of Poly-ICLC and/or Keytruda with DCVax-L in a trial, whether it's considered confirmational, or not. The last thing I'd want to do is another monotherapy trial with what I know is possible with the addition of other therapeutics.

All I'm suggesting is that the company may be pushing hard to do things right. While approval is the key, if they had a chance at tumor agnostic, spent a few extra months trying to get there, but ultimately failed, I believe it was still worth the try. We'll really never know as the story will never be told. On the other hand, if they do get a tumor agnostic label, I think it's fair to believe it extended the time it took to get the yes.

Gary

[froggmister]

You are avoiding the obvious question. Why expand access to compassionate care if you are going to recommend rejection?

[jesster64]

You're playing around with semantics now. If there was any question about approval, they would yank compassionate care use in an instant to stop any future lawsuit. Didn't a member of parliament ask the MHRA directly about the status of dc-vax a few weeks ago? Answer was given MHRA is working together with NWBO. There is no mention of appeal or CHM.

" NWBO's sudden reappearance only to talk about other products supports this"

as a theory, one of a half dozen theories on why the delay. One PR about a speech and you believe it proves something negative is going on because they are now promoting another version of dc-vax?
I haven't heard anything from the company directly, so I don't believe in reverse split, i don't believe its been referred to CHM, I don't believe we are in another BLA halt, I don't believe we submitted to FDA, and I don't believe any timelines posted here.

[dennisdave]

f the MHRA wants to reject, they must first refer it to a CHM meeting for review. Once that happens, and the CHM backs the MHRA's recommendation to reject, NWBO is then allowed to go through an appeal process which can take months if not years.

You are partially misstating this.

After a negative CHM opinion, the company has the right to make written and/or oral representations before a final refusal is issued. This is not called an "appeal" in legal terms, but rather a representation stage, akin to an internal review process. Regulation 126(5) of the HMR 2012:

“The applicant shall have the opportunity to make representations before a final decision is made by the licensing authority.”

There is no automatic appeal to an external court unless the refusal is formally issued and challenged via judicial review, which is rare and costly.

The CHM review and representation process can add several months, especially if the applicant requests oral hearings. In unusual or contested cases, the process could stretch longer but years is not typical unless the company delays or launches judicial review proceedings post-refusal. In practice, 3–9 months is a more grounded expectation between the start of CHM involvement and final MHRA decision (approval or refusal).

Only after the appeal process is complete and the CHM still recommends to reject does the MHRA actually have the authority to officially reject the application

MISSTATED. The MHRA already has the authority to issue a rejection after the CHM review and applicant's representations are complete.
The CHM does not "grant" that authority; it advises. The MHRA retains final decision-making power. So, MHRA doesn’t need the CHM to “still recommend to reject” at the end of the process to proceed. If the representations don't change the outcome, MHRA can finalize the refusal.

if NWBO were formally notified of a CHM-backed recommendation to reject their Marketing Authorisation Application (MAA) and did not disclose this to investors in a timely manner, it could indeed constitute a serious violation of U.S. securities laws, particularly SEC Rule 10b-5 under the Securities Exchange Act of 1934.

Rule 10b-5 (anti-fraud rule):

It is unlawful for any person... to make any untrue statement of a material fact or to omit to state a material fact necessary in order to make the statements made... not misleading... in connection with the purchase or sale of any security.
A material fact is anything a reasonable investor would consider important when making an investment decision.
A regulatory setback — such as an official notification that the MHRA is intending to reject an application (especially if endorsed by the CHM) — would absolutely be material to NWBO investors.
Silence in the face of material bad news can be just as actionable as making false statement

If NWBO: Withheld a known regulatory rejection trajectory;
Continued to issue promotional or forward-looking statements without disclosing that risk;
And investors suffered losses once the truth emerged...
Then: The company and its officers could be liable for securities fraud; They could face SEC enforcement, class action lawsuits, and personal civil liability.

Thus and therefore the 10Q for Q2 will be very interesting IF by then still no news.

[Hopeforthefuture3]

FeMike, interesting theory, does explain the recent direct presentation digging out some of the same material on direct presented in slides from 2016 and 2017. Possible diversion for shareholders starved for any real news. Hope this is incorrect and L approval will still come.
Remember all the discussion on approval later in the year in the fall (of 2024) perhaps LG just meant 2025

[QL300]

If you truly believe that, you would sell now and move on. This company probably won't survive without approval. 

[skitahoe]

Mike, if a company were in a multi-month or year of negotiating an approval, I believe they would also have a clear understanding of where the regulators found their application lacking. While not conceding, as discussions continued, they would be foolish not to also prepare to answer what the regulators are saying are shortcomings with new trials intended to strengthen the data.

In NWBO's case, while money is tight, I still believe that if it's clear more trial data may be needed, without stating why, a new trial would have been started. I believe that NWBO could easily have initiated a trial with either Poly-ICLC and/or Keytruda, either of which could produce dramatically stronger data. These trials are intended to begin after approval, but if it's still being debated, I believe the LP could find a way to fund the trials more immediately.

The fact that this hasn't been done is an indication IMHO that she feels quite certain that approval is coming. She and few others at the company may know that the debate is over the label, tumor agnostic vs brain cancer, I can certainly see the company taking the additional time if there is any possibility of a tumor agnostic label. I'd also point out that if the EDEN is also being evaluated, that may be a part of it, but even if not, it's providing more time for EDEN development.

Gary

[Doc logic]

FeMike,

In my opinion, this whole process has been about being a poster child for a new regulatory program while buying time for Flaskworks, optimizing the quality life years from survivors for reimbursement purposes, planning for Real World Evidence and Data to be developed through IFRs for use in an expanded label for all solid tumor cancers and generally getting the regulatory house in order to do all of this and make a huge step forward in the way future trials will be conducted. Investors are being asked to be patient throughout this whole process while not being given anything but hints about the transformation going on in which every step seemingly requires a “bigger boat” for NWBO; ). Best wishes.