NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Hi Doc, 
Standard of Care or ("SOC") is also a U.S. legal concept.

In the U.S.:

Definition:
The standard of care is generally defined as “the level and type of care that a reasonably competent and skilled health care professional, with a similar background and in the same medical community, would have provided under the same or similar circumstances.”

Legal Standing:
Unlike the UK, there is no single codified document or government-issued SOC in the U.S. Instead, it is a legal concept used in malpractice litigation. Courts rely on expert testimony, medical guidelines, and professional consensus to determine what the SOC was in a given case.
• Sources of SOC:
• Peer-reviewed medical literature
• Specialty society guidelines (e.g., American Society of Clinical Oncology, American Heart Association)
• FDA-approved labeling and accepted treatment protocols
• Expert witness testimony in court
• Common clinical practice patterns

Legal Implications:
Failure to meet the standard of care can form the basis for a medical malpractice claim. If a physician deviates from the SOC and harm results, it may be considered negligence.

However, unlike the UK description, the burden of proof remains on the plaintiff (the patient or their representative) to show that the doctor breached the SOC and that the breach caused harm — not the other way around.

In summary:

SOC is both a recognized and legally relevant concept in the U.S., but:
• It is not a formal guideline or law; rather, it’s a standard used in legal and professional evaluation.
• It can evolve as new evidence (like from DCVax-L or poly-ICLC + pembrolizumab combinations) becomes widely accepted in clinical practice or published in major medical guidelines.