Replies to post #765159 on NorthWest Biotherapeutics Inc (NWBO)

[SemperFITrader]

Thank you! Lykiri

[NotSure2]

This confirm FEMIKE's take.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=176133165

Whats funny is even though it is the same meaning, the primary school kids put the "bad" emoji on Femike's explanation, but the thumbs up on Lykiri's explanation.

[BetIsOn]

Thanks a lot. Lykiri. Do you still feel comfortable about approval around mid-May?

[Jackxkr]

How do you read anything positive about this? I wish it was in backlog that would explain the delay. With RWE from the compassionate this should have breezed through of the results were good, why didn't that happen.

[DrHigh]

Lykiri is the GOAT🐐

[StonkMaster]

Thanks Lykiri!

[RobotDroid]

This is one of the few examples of good due diligence. Interesting, and since communicated the worlds worst ceo could have pr'd that to assuage suffering SH. Good find.

[learningcurve2020]

If it wasn’t in the backlog where was it? Not delayed? Something doesn’t add up. We need to trust your communication, of course,

>>Medicines licensing applications: On 31 March 2025, we cleared all backlogs related to licence applications for innovative and established medicines. All new national licence applications submitted after 1 September 2024 continue to be assessed within our target of 210 days: with an average timescale of 160 days in March. We also completed 100% of assessments of International Recognition Procedure (IRP) applications within statutory timeframes in March.

[The Danish Dude]

This is by far the best news I’ve read in ages.

Can’t thank you enough for this 🙏🏻

[sentiment_stocks]

Right! Thanks, Lykiri, the board member's replies are ... interesting.

If it was "delayed in assessment", it could be argued that the application might have "major objections". Since it is NOT delayed in assessment (nor, interestingly, "has not been" delayed), one can logically, IMO, assume the assessment is moving forward "normally".

This supports the positive view that the application is proceeding through the normal (albeit lengthy) assessment and inspection phases, and that it was never among the applications with major issues precluding approval.

To confirm this application has not been in backlog or delayed in assessment.

The "has not been" comment seems to indicate that at no time has the application been in backlog, either. Which is unusual, given the time the application has taken thus far.

Still... if it's not in backlog, then DCVax-L is certainly NOT one of the somewhat wounded "outstanding" applications within backlog with major objections.
And if it's not delayed by assessment, I would think it's not in another RFI clock-off.

So the question is, if it's not in backlog, and it's not delayed by assessement, and it's not been refused (or we'd have to be told by the company)... where is it?

:)

[manibiotech]

Thanks Lyriki

[Chiugray]

Lykiri, Thanks for the information. Given the MHRA responded that the DCVax-L MAA was not backlogged, not delayed, and not refused, here is a scenario for possibly why we are going into May 2025 still waiting, just speculation.

- The MAA had included the UCLA's Phase 2 brain tumor clinical trial data (DCVax-L and poly-iclc) as additional supporting information. Included in that data was a small data set for grade 3 glioma brain tumors. Where external survival data shows average survival at 27% at 5 yrs, this UCLA trial showed 100% survival at 5 yrs and 75% survival at >10 yrs.

- Possibly discussions between NWBO and the MHRA indicated they were supportive to expand labeling to include Grade 3 gliomas. But doing so would require several extra months in the approval process, and let's say could push the anticipated approval into Q2 2025.
(The Nature Journal on this trial was published 5/8/24.)

- By coincidence NWBO has all along been trying to validate the Flaskworks' Eden system for commercialization in parallel with the MAA throughout 2024. Validation is a much longer process and had a potential time frame for somewhere around Q2 2025 as well.

- Both the MHRA and NWBO know that once a drug approval happens, the company is obligated and will be pressured to invest heavily in the ramp up for commercialization. These would include major, long-term, hard financial commitments (especially long tail order requirement items for manufacturing), on a manual system when approval for an automated Flaskworks system could just be a couple of months later.

- Judgement-call was to go for a grade 3 glioma label and time the approval of DCVax-L to roughly coincide with the approval and validation of the of Flaskworks' Eden automation system.

Note
- Remember that there were rumors of additional inspections in Jan/Feb 2025, that makes me think of manufacturing systems validation.
- The recent 10-K comments that grade C labs have not yet been constructed for Flaskworks refer to commercialization. It does not preclude a Flaskworks validation has been happening in parallel.

[dennisdave]

My conclusion from this exchange:
From this conversation, I conclude that the DCVax-L application has never been classified as a backlog case, nor has it been delayed due to major objections or assessment stoppages. The MAA has remained in continuous assessment throughout, without falling into the category of stuck or problematic applications that required intervention by the Commission on Human Medicines (CHM). This supports the positive view that the application is proceeding through the normal (albeit lengthy) assessment and inspection phases, and that it was never among the applications with major issues precluding approval.

exactly and a second RFI sent to NWBO at the end of March is within that margin. Just because it doesn't fit peoples perspective thrown out by Tunnelvision doesn't mean that DCVAXL application is facing problems its not. It was Tunnelvision that was applauded and hailed here, I was always skeptical about his timeline, whereas there is a different, longer timeline for the DCVAXL application with two RFI's. NWBO is now in the second clock off time