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Andrew Caravello, DO @andrewcaravello on x 1084 followers
Created: 2025-07-22 22:04:30 UTC
𧏠This Is How You Launch an Immune Engine in X Months #DCVax, CNPV, and the Rise of the Modular Cancer Vaccine $NWBO $MRK $PFE $BMY
The FDA didnât just open a new review pathway They created a fast pass for therapies that can change medicine
Itâs called the Commissionerâs National Priority Voucher (CNPV) and if executed correctly, it could deliver full FDA approval for DCVax-L in X months or less DCVax-Direct isnât far behind And the Mayo Clinic already proved the method
Hereâs how it works
âąď¸ Step One: The Voucher That Changed the Game
No BLA required to apply No need to restart trials Just submit a Statement of Interest And if the FDA agrees, they grant a voucher that compresses review to 1â2 months
Itâs the fastest regulatory path ever created for non-emergency cell therapy
đ§ What NWBO Already Has
DCVax-L: Phase III complete, peer-reviewed in JAMA Oncology Cryopreserved, patient-specific product, already used in the UK Flaskworks-enabled, GMP-compliant manufacturing in motion Draft labeling and CMC ready Public health priority? Glioblastoma is nearly XXX percent fatal No new durable therapies in XX years
DCVax-L qualifies now The only thing left is to submit
𧪠What About DCVax-Direct?
The platform is proven, in real humans Not preclinical theory Not promising data
The Mayo Clinic has already completed a series of human trials using autologous dendritic cell vaccines, just to name a few:
⢠Melanoma
⢠B-cell Non-Hodgkin Lymphoma
⢠Non-Hodgkin Lymphoma (checkpoint combo)
⢠Glioblastoma
⢠Liver Cancer (hepatocellular and/or cholangiocarcinoma)
⢠Recurrent Glioblastoma
And those are just part of a broader clinical footprint. Mayo has conducted multiple dendritic cell vaccine trials, including in glioblastoma, that further validate this approach. The evidence isnât theoretical, itâs already in human data, across indications.
Each of these trials used:
â˘Autologous dendritic cells â˘Intratumoral or intradermal delivery â˘Cryoablation or radiation-based pre-conditioning â˘Immune activators (including Merckâs Prevnar13 or Pneumovax in several protocols) â˘And most importantly, real human patients, not models
These trials prove the logic of DCVax-Direct and show that the method is clinically reproducible, scalable, and safe across indications.
đď¸ The Fastest Path to Approval and Deployment
Step 1: NWBO submits CNPV SOI
Step 2: Flaskworks pod deployed inside a U.S. GMP facility
Step 3: CMC plus draft labeling filed (at least XX days before BLA)
Step 4: BLA submitted
Step 5: FDA reviews and rules within 1â2 months
Total time from SOI to approval: 4â6 months
𧏠And Hereâs the Bigger Opportunity
With peer-reviewed efficacy in glioblastoma, and human data from Mayo across melanoma, lymphoma, liver cancer, and more, DCVax isnât just tumor-specific. Itâs mechanism-based. That opens the door to a tissue-agnostic label, just like Keytruda for MSI-high.
The FDA has already approved therapies based on immune logic, not location. DCVax fits the profile.
If NWBO pursues that pathway, the result wouldnât just be approval, it would be platform clearance across cancers.
đ Could Merck Host the Launch?
Merckâs West Point campus has:
FDA-inspected, PIC/S-aligned cleanrooms Cryogenic storage and QA/QC A facility (Building 63A) designed for sterile biologics
A track record: their own vaccines were used in Mayoâs DC trials
Plug Flaskworks into one of their cleanrooms, and Merck could power U.S. production of DCVax-L tomorrow
One pod One suite Global impact
đ No Trials Needed No Excuses Left
CNPV doesnât require a BLA to apply It doesnât require new studies It only requires one thing:
A therapy that matters
DCVax-L already has Phase III proof DCVax-Direct already has human validation via Mayo And Flaskworks makes it deployable on demand
𧊠The science is done The infrastructure is real The regulatory door is wide open Now itâs just a question of who partners, and who hesitates
XXXXX engagements
