Replies to post #741258 on NorthWest Biotherapeutics Inc (NWBO)

[StonkMaster]

Fantastic, thank you.

[Steady_T]

Thanks for putting in the time and effort to do that review/analysis. Helpful to provide context.

[dstock07734]

From another angle, Direct will be restarted the end of January. Three trials related to $NWBO are set to start the end of January. So LP is expecting the approval in January.

Re-Start of the DCVax-Direct Clinical Program. As previously reported, preparations to restart clinical development of DCVax-Direct have been under way for quite a while. The Company currently anticipates that the DCVax-Direct program will be able to restart by the end of January.

This trial from Roswell will start the end of January.
https://clinicaltrials.gov/study/NCT05539365

This tumor-agnostic trial from Roswell that LP mentioned in 10Q has not started. I assume it is going to be started the end of January.
https://clinicaltrials.gov/study/NCT04093323

This trial on CYT107 will start the end of January too.
https://clinicaltrials.gov/study/NCT06523699

[exwannabe]

- There have been 6 medicines that had their first CHM meeting in H1 2024 and have already received approval. The average time from first CHM meeting to approval was roughly 6 months. (Compare this to medicines that had their first CHM meeting in 2023 or earlier, which took from 9 to 11 and as long as 13 months.) ...

The vast majority of the MHRA work is for established medicines and drugs being approved based on a EMA approval (or Orion, or now the IRL that replaces both). These are very different from NMEs using the national pathway.

As far as the disclosure issue, I see very few companies mentioning MHRA much at all. The issue wrt an RFI was that longs were asserting that as it was never disclosed it did not happen. The real issue with NWBO is disclosure is the PR minor stuiff and big issues they have a radio blackout.

. Actual plans for FDA/EMA submissions
. Reason for the FDA hold
. FDA/EMA post P3 meetings
. Commercial contract with Advent for mfg
. NICE evidence submission

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[Jackxkr]

These poster's pumpers and bashers alike never venture past there window's. I bet the only way they see the light is through their security cameras. I expect to be ringing in the new years through a rock glass with ice cubes with neighbors.

[flipper44]

Thank you TVA. Happy New Year!

[Ready4Nxt]

Tunnel: Thanks for your research. Hoping 2025 is a "Vision of Plenty"!
Best 2025 wishes to true longs.

[Lykiri]

Thanks tunnelvisionofplenty.
After the recent update on the CHM meetings earlier this month, I also tried to figure out how many medicines had been submitted earlier than DCVax-L and were still awaiting approval from the MHRA. It wasn’t an easy task, but I concluded that there were probably 3 or 4. You’ve done a much better analysis by even identifying the three medicines by name. Thank you so much for your fantastic work, and I wish you and everyone here a Happy New Year!

[KRISGO]

I appreciate your detailed analysis. Q: any idea on the drugs that have been rejected by the MHRA, how long it took them to deny them?

[tucsonchas]

Tunnel, outstanding research and analysis. Thank you ever so much. Happy New Year to you and yours.

[Doc logic]

tunnelvisionofplenty,

Great job digging and thanks for sharing. Your kind of contributions are why many come to this board for info. Happy New Year and best wishes.

[biosectinvestor]

Thank you, tunnelvisionofplenty, for this thorough breakdown. Your insights provide a much-needed clarity on a potential timeline and approval process. Although such posts are always speculative, your analysis suggesting that DCVax-L is progressing efficiently, especially compared to historical trends, is encouraging. Your discussion of the broader approval landscape and the context that you have given help to provide a thoughtful baseline for discussion. It's refreshing, given all the posts by bashers, distorting the circumstances constantly.

Wishing you a wonderful New Year as well, and looking forward to what the upcoming month/s may bring. Your contributions to this discussion are much appreciated!

[mike00h]

Thanks for the extended research and lucid summary you gave us.

Was any mention made of the size of the application? I recall that ours was 1.7M pages. I wonder if size/complexity is a factor in the progress.

[Lykiri]

gallium-68 (68Ga) gozetotide (a medicine for diagnostic use only to allow the imaging of prostate cancer). This medicine had its first CHM meeting on 4/25/24. It goes by the name Illuccix, and is owned by Telix Pharmaceuticals. It has been languishing in the process for a long time – this is the poor drug that had to wait a full year for its first meeting. Also, it is the one drug out of the 24 I looked at that publicly mentioned receiving its RFI. One single drug, out of 24. So next time someone tries to tell you it's unusual for a company not to PR updates, know that they are just making that up. And if you are one of the people here clamoring all day every day about the company's "unusual" or "suspicious" strategy regarding communications about this process, know that you are wrong, and everyone here knows you are wrong

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13 Jan 2025

MELBOURNE, Australia and INDIANAPOLIS, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today provides an update on its commercial and operational performance for the quarter ended 31 December 2024 (Q4 2024)

Illuccix® global regulatory submissions: The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, or BfArM) is expected to provide its decision on the Company’s EU marketing authorization application on 15 January 2025. In the United Kingdom (UK), the Company has responded to all queries with no substantive issues raised. The UK regulator (the Medicines and Healthcare products Regulatory Agency - MHRA) is experiencing significant administrative delays but an approval decision is expected this month. The Brazilian Health Regulatory Agency (ANVISA) is expected to provide a decision imminently after protracted administrative delays also unrelated to Telix’s marketing authorization application.

https://ir.telixpharma.com/news-releases/news-release-details/telix-exceeds-fy24-guidance-us142m-q4-revenue-0

18 July 2024

Telix is expecting to receive a regulator’s assessment report by the end of July 2024 from the UK Medicines & Healthcare Products Regulatory Agency (MHRA)

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22 August 2024

The UK Medicines & Healthcare Products Regulatory Agency
(MHRA) regulator's assessment report has been received with no substantive issues raised. Decisions expected in H2 2024

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[iclight]

I don't think it's flibanserin, as EU regulators indicated long ago it wouldn't be approved even after approval in the US.

It shouldn't have been approved by the FDA anyway. It does nothing, just like DCVax-L.

Most likely AdroFeme which had it's MAA accepted March 16, 2023. It's already been approved in Australia (where the company is based).

[dennisdave]

Contrary to one frequently shared opinion, DCVax-L appears to be moving faster through the process than other drugs.

this turned out to be nonsense fast