Replies to post #772508 on NorthWest Biotherapeutics Inc (NWBO)

[Zadie420]

Exactly. There are many other players that can serve our purpose. We need to start this move ASAP. Merck has been buying many other companies to just try to mimic our combo results but then failed. LP needs to deliver as simple as that.

[manibiotech]

Then what will Merck do with millions of sq feet they are building 

[ilovetech]

I recommend reading the post again. You misunderstood the point.

[maverick_1]

The Ongoing SAGA with Merck

Beyond my 2018 discovery no update
Mainz Univ Colorectal PH2 MSD & NWBO study

°2019 ASCO MRK EVP Perlmutter w/ 4 personal assistants snapshots of NWBO presentation followed by long chat & handshake farewell with MAESTRO
° Dr Kevin Duffy PhD @ NWBO offices for ~a year
°2021 BIG build out of MRK's West Point, PA facilities as profiled extensively here by DStock 's posts.
°MAESTRO deliberated for a few months Late Summer 2022 on LOW Ball Offers
° Oct 2022 peer reviewed JAMA backed by 70+ world experts

If anyone at @bmj_latest @undarkmag @Health_Affairs @propublica @TBIJ @theintercept @PLOSMedicine @ASLME @sciam @WIRED @nature @newscientist @CIRInvestigates @CenterIntegrity @FrontlinePBS @MotherJones @TheLeverNews @correctiv_org or anyone committed to transparency in cancer…

— Andrew Caravello, DO (@andrewcaravello) June 22, 2025

🧠 How Do We Know the Trial Was Listed — and Was It Required?

You’re right to ask. Here’s why we’re confident that the DCVax-L + Keytruda + Hiltonol colorectal cancer trial (NCT03952735) was publicly registered on http://ClinicalTrials.gov before it was deleted, and how that intersects with the rules around trial registration:

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✅ 1. The Trial Had a Valid NCT Number — That Means It Was Registered
•NCT numbers are only assigned once a study is submitted and officially listed on http://ClinicalTrials.gov.
•They are never pre-reserved or issued as placeholders. If a number exists, it was live at one point.

So the existence of NCT03952735 is itself proof that it was registered.

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✅ 2. The Trial Was Voluntarily Registered — It Was Not Legally Required

Here’s how U.S. law works:

▶️ FDAAA 801 (U.S. Law for Trial Registration)

Under the Food and Drug Administration Amendments Act of 2007, registration is required only if:

Legal RequirementApplies to NCT03952735?
Drug or biologic regulated by FDA✅ Yes (Keytruda, DCVax-L)
Interventional Phase II–IV trial✅ Yes
Conducted under IND or has U.S. site❌ No (It was run in Germany)

🔒 Source: 42 CFR §11.22

✅ Conclusion:
Because the trial was conducted entirely in Germany and not under an FDA IND, it was not legally required to be listed on http://ClinicalTrials.gov.
That means its appearance in the U.S. registry was voluntary—a strategic choice.

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✅ 3. The Trial Was Then Deleted — Completely

Here’s what makes this situation different from almost every other trial:
•The trial is not marked “withdrawn,” “terminated,” or “completed”
•There is no public record left in http://ClinicalTrials.gov
•There is no snapshot available in the Wayback Machine
•There is no metadata trace in the AACT (NIH internal archive)
•There is no record in EudraCT or CTIS (EU systems)

This is not normal behavior.

Withdrawn or failed trials remain up for years — with status, dates, and documentation. But NCT03952735 has been fully scrubbed. That kind of erasure is only possible after a valid registry listing, followed by a formal request to remove it—something that must be initiated by the sponsor.

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🧩 4. Why It Was Listed Voluntarily

If the trial wasn’t required to be listed, why was it?

Because:
•Sponsors often list trials voluntarily to boost transparency
•It may have been a prelude to an FDA IND filing
•It showed the collaboration between NWBO-linked platforms (DCVax-L), Merck (Keytruda), and Hiltonol (Poly-ICLC)

But once it was listed, and attention grew, the pressure to remove it likely came from:
•Intellectual property concerns
•Trial data showing unexpected signal
•A strategic desire to suppress visibility of the platform stack

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🧠 Why This Matters

This isn’t just a missing trial. It’s a voluntarily disclosed Phase 2 trial involving a rare triple-stack immunotherapy in MSS colorectal cancer—one of the hardest indications in oncology.

And it was intentionally deleted, not because of compliance—but because of strategy.

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A highly intriguing Chapter with tributaries to this EPIC

Not likely to find resolution

The STAKES are high bounded by a barrage of legalities and stacked. In this Darwinian Struggle

DIFFERENT STROKES for DIFFERENT FOLKS

[dstock07734]

Well, LP wants to sail through a big ocean to do treasure hunt, she needs a big yacht. But she only has a small boat. LP comes to Merck with the map to get the treasure. Merck is excited and is working day and night to get the yacht ready. Merck has to work hard since there is a rumor that LP also reached others for a big yacht (Baker Brothers, Amgen, AZN, Roche, etc). Not a good illustration. But you get the point.