NorthWest Biotherapeutics Inc (NWBO)

[Smitty5150]

Would you mind showing my official language from the FDA or MHRA in regards to "off-label" use for a indications the drug, or in this case , a vaccine is recommended for off-label use and that they support it legally? You cannot, because there is none. Off-label use is between the Doctor and the Patient. And as such there is risk involved. Particularly with a new personalized cancer vaccine that is very complicated...the legal ramifications can be lethal. We are not talking about Humira or something similar, which is off-labeled for a lot of other things besides what it was officially approved for. But its been around a long time and data exists FROM TRIALS that support the off-label use. I am not saying DCVax will never be off-labeled, but it will take more data = years away.

Off-label prescribing is legal and is commonly done by many physicians. It is also acceptable to study and publish research results for off-label uses of drugs without specific FDA approval. Off-label drug use is often a benefit; however, drugs prescribed this way should be backed by published, high quality studies showing safe and effective use.

https://www.drugs.com/medical-answers/what-label-prescribing-why-doctors-3573879/#:~:text=Off-label%20prescribing%20is%20legal%20and%20is%20commonly%20done,high%20quality%20studies%20showing%20safe%20and%20effective%20use.