Thanks for continually reposting that question hundreds of times 😶
Fact ✅️: NWBO has not filedYET.
We do not know why there is a BLA delay, but we do know that a BLA in the U.S. is different than an MAA in the U.K., & some components of the filing package would be different.
DC vaccines are complex products, & the FDA insists on strict GMP consistency & scalability.NWBO may still be finishing standardized automation development & validation for that part of the BLA package, & if the FDA wanted more progress on standardized automated manufacturing, that could easily delay filing.
While it true that a new drug candidate does not need huge mass production capability to be approved, commercial production must be established & observable — commercially scalable.
For a small clinical-stage biotech, manufacturing an individualized novel cell-based product is a monumental feat when it comes to commercialization. NWBO has made great progress toward that milestone achievement:
DCVax-L is in artisan production in the U.K. today, Eden is in active development, & the Roswell products are slated to be manufactured at a site in the U.S. (NWBO has narrowed their search/negotiations to include 2 finalist manufacturing sites in the U.S.).
“In 2007, Dendreon's application for PROVENGE was denied because it lacked sufficient information to prove the product's safety, effectiveness, and the ability of the manufacturing facility to consistently produce a safe, pure, and potent product.”
HyGrow, so what that NWBO didn't choose to file in the US as they chose MHRA instead, but the FDA knows the capabilities of NWBO and DCVax, IMO, Your BS story still stands as you claimed you had specific proof that the FDA rejected NWBO but again you failed to provide it per normal, IMO. As for your comments, they are a waste of time and have no value as you continue to evade the truth, but you know that DCVax should be approved and it has the capability to cure cancer and that is a fact, IMPO.
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