NorthWest Biotherapeutics Inc (NWBO)

[jimmy667]

I believe what Gary is referring to as laws are CFR. Federal Regulations promulgated by jurisdiction and power granted by laws enacted by Congress granting authority to Federal Agencies to set those regulations.
Congress set the policy with statutes those statutes enable the various Federal Agencies to set Regulations which the Agencies of the Executive Branch uses to put into action the MANDATES of the Statutes enacted by Congress. Same at State level. Federal Regulations have the power of law based on the enabling Statutes granting the power of the Agencies to promulgate those regulations.
Short answer is that an Agency which is an arm of the Executive branch can set regulations and amend regulations all within the scope of the LAW which is the Federal Statute passed by Congress directing the Agency to effect action.

So can Agencies break or bend those Regulations they themselves set?
No. Industry needs to rely on stable Regulations as published.
Industry can not be held liable as long as the are in compliance with the current regulations.
So the question resolves can the Executive Agency be to forced to enforce the Agency Regulations in specific instances?
All that has to be done by the Agency is issue an update to Regulations that covers the specific instance. Clearly within the power granted by stature so YES they have wide ministerial powöer to amend the regulations as they see fit.
The Agency can not fine for actions not prohibited by current regulations but if the Agency wants to modify those actions prospectively they just need to amend the regulations. No statute required.
This is how the FDA works. These regulations are in flux. The best example is the vaping industry where they are micro managing down to the regulations of the flavors of the vape.
Also there is wide discretion on how to enforce current regulations in specific instances as in recalls of OTC products with levels of carcinogens.
HOW IS THIS FDA REGULATORY POWET CURRENTLY AFFECT NWBO?

SUPER POSITIVE AS DR PAZDUR SIGNALED IN THE ANNALS OF ONCOLOGY

THE FDA SEEMS TO SIGNAL THAT POLICIES AND REGULATIONS WILL BE AMENDED TO GREEN LIGHT DCVax.