NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

antihama, even the intro of that FDA guidance states that when companies are applying for marketing approval, they are not only required to include the clinical trial data that proves that their drug or treatment is safe and effective, but they must also include supporting, non-clinical data from animal or in vitro studies that prove that the treatment performs in the patient, or has the pharmacological effects or mechanism of action, the way that the company claims:

II. BACKGROUND
A. Nonclinical Studies and Their Role in Drug Development

Applicants are required to submit, among other things, nonclinical information to support approval of an NDA or BLA (see, for example, parts 314 and 601 (21 CFR parts 314 and 601)).  For example, the NDA regulations provide that NDAs include data about the drug’s pharmacology and disposition (pharmacological effects, including mechanism(s) of action; absorption, distribution, metabolism, excretion) and toxicology (acute, subacute, and chronic toxicity; developmental and reproductive toxicity; carcinogenicity; and special toxicology, as appropriate). The NDA regulations note that these data can come from studies conducted in animals or in vitro. “

It appears to me, that’s exactly what Northwest Bio proved when they conducted a proteomic analysis (the study of proteins (antigens); their composition, functions, and interactions) on DCVax. Dr. Bosch’s ASCO presentation clearly demonstrated the various antigens and the number of T cells that were present prior to DCVax administration, which antigens and the number of T cells that were present after DCVax was administered, the mechanism of action proving that the dendritic cells pick up those antigens from the tumor lysate, then present those antigens and activate the T cells, which respond by multiplying and migrating to the tumor site to kill the tumor cells.

While the MOA has been theorized for years, the actual data from this analysis is completely new information, which seemed to be timely and relevant in light of this new FDA guidance, but I admit that I could be wrong and there’s not any connection. Carry on.