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Sojourner55

10/21/17 11:29 AM

#139834 RE: HappyLibrarian #139824

With MD Chris badgering him day and night on Twitter, he might just tell his underlings to get this DCVax approved and this guy off my back. Lol.

Chris: keep up the messaging. Good work.

biosectinvestor

10/21/17 1:07 PM

#139846 RE: HappyLibrarian #139824

DCVax-L is not a "gene" therapy, it's an autologous cell therapy, the cells being the patient's own dendritic cells. They are not modified genetically. Therefore it's not a gene therapy. It does relate to vaccine technology, but using autologous cells to create immunity. Exposing the cells to the antigens from the patient's own tumor is also not gene therapy.

The current Car-T therapies are gene and cellular therapies because they modify autologous cells (taken from the patient) genetically, though some are working on other forms of modification, including small protein modification, which may or may not be gene therapy and which potentially don't change the genetic blueprint of the cell at all (no fingerprint). In all the current cases, the cells are autologous, but some companies are working on off the shelf cellular technologies, creating all the car-t's from generic induced pluripotent (could also be embryonic) stell cell lines that are used to create vast pools of cells that can then be grown into Car-T cells with the right properties.

mapman1010

10/21/17 7:30 PM

#139872 RE: HappyLibrarian #139824

not the case;

A lot hinges on whether Dr. Gottlieb thinks DCVax-L falls into the category of “other gene therapies” that his statement alludes to.


Gotlieb is talking about regenerative medicine;

We will soon release a comprehensive policy to address how we plan to support the development of cell-based regenerative medicine.


NWBO qualifies for RMAT. one of many reasons NWBO is silent.