"The current data, which conclusively demonstrates the induction of immunological memory to cancer, as well as the natural killer cell as a mechanism of action, will position us to provide the FDA responses to their questions from our submitted IND," said Dr. James Veltmeyer, Chief Medical Officer of the Company.
GMP certification and Manufacturing Authorization pave the way for the company to deliver fully characterized clinical-grade iPSCs that are derived from human cord blood cells for the development of cell-based therapies.
The company advises this EUA amendment will allow 3B BlackBio Biotech’s North American distributor, Genophyll Enterprises, to expand saliva COVID-19 PCR-based viral diagnostic testing across the U.S. as well as from their upcoming New Jersey-based laboratory.
Briotech notes that in addition to its flagship product, Briotech Topical Skin Spray, Briotech produces Super Oxidized Saline for oral use, and an EPA approved Multi Surface Sanitizer + Disinfectant effective against coronavirus (the novel SARS-CoV-2 pandemic virus that causes COVID-19).
Eurofins has decided to donate part of its sequencing capacity to national public health authorities who do not have already approved funding to identify VUI2020-12/01 in their positive samples to evaluate local prevalence of this new strain.