Replies to post #799515 on NorthWest Biotherapeutics Inc (NWBO)

[sukus]

But you are not regulators right? But why you act as if you are regulators?

[SkyLimit2022]

High-Ranking Officer e❌,

Thanks for posting on a weekend 😶

Of course you can never lose as you will just always say "soon" year after year.

It’s not always “soon.” A lot has actually happened over those years, including regulatory approvals required for commercial approval — that’s a fact, whether you care to acknowledge it or not.

Both clinical & regulatory progress have advanced in a steady, coordinated path toward commercial readiness & expansion. Patients are being treated TODAY. Ironically, your daily posts & reposts only underscore that continuing progress.

Fact ✅: There was a time in recent history when NWBO had only ONE asset…

Today, NWBO has FIVE+ asset categories. Shorts are finding their position more & more precarious with each step of progress.. that’s why we see the fud flood here 24/7

NWBO’s Assets Include:
⭐️ DCVax®-L & DCVax®-Direct
⭐️ Roswell DC platform(s)
⭐️ Flaskworks Eden technology
⭐️ In-licensed TLR agonist
⭐️ Fully licensed & operational in-house GMP facility

Fact ✅️:
Regulatory agencies may choose to consider independently peer-reviewed publications as part of their overall analysis. The MAA review is just one of several regulatory reviews to come as NWBO is developing several technologies/products. The examples below are relatively recent publications & Dr. Kalinski is currently working on another paper right now…



Nature Comms



JNS



JAMA Oncology

Fact ✅:
The MHRA has already awarded several approvals, including their approval of the MIA (a prerequisite of the MAA) & their ongoing support of the DCVax-L Specials Program.

Mar 2023, NWBO & Advent MIA Approval


Aug 2022, NWBO PIP Approval


Dec 2021, NWBO & Advent GMP License Approval



Regarding the P3, enrollment completed years before 2020, but patients continued to be treated & followed under the trial protocol as trial participants after enrollment closed. The P3 trial concluded in 2020, & data lock happened in Q4 of 2020…

COMBOS with checkpoint inhibitors & other agents are much more recent & have reached P2 for both DCVax-L & the Roswell DC technology platform.

⭐️Combo is King!⭐️




⭐️ Expanding Manufacturing Capacity

⭐️ Lifetime Achievement Award in Medicine, Dr. Liau

⭐️ AACR Advances in Ovarian Cancer Research

⭐️ NWBO to Acquire Advent BioServices

⭐️ Recent Conference

⭐️ DCVax-L Combo PII UCLA

⭐️ DC Combo PII Roswell Park

⭐️ 10-Q Quarterly Report

⭐️ 10-K Annual Report

⭐️ NICE UK 🇬🇧 DCVax-L

⭐️ ASM June 29, 2024

⭐️ Manufacturing Technology

⭐️ NWBO Acquires Flaskworks

⭐️ Roswell Park IP Portfolio

⭐️ TLR3 agonist Ampligen (rintatolimod)

⭐️ Next Generation Dendritic Cell Treatments

[flipper44]

If so, so what? Post-approval confirmation trials occur all the time.