MSB to dispute FDA finding in Type A meeting, page-224

That's totally 100% wrong. Do you think MSB doesn't have high-powered, experienced lawyers assisting in putting together and arguing their application?! That they just prepared it themselves? And do you think their lawyers don't have contacts within higher levels of the FDA and government that can be asked to consider lending their name (and some weight) to MSB's arguments?

There is nothing at all wrong with bringing your application to the attention of government officials outside of and at higher levels in the agency handling that application.

It is not about paying bribes (which I assume is what you are implying).

It is about bringing your concerns to the attention of government officials and making sure that the agency that is handling the application does so in a reasonable, lawful and well-considered manner.

This is what happens EVERY DAY in government.

What do you think ex-FDA officials working in law firms do? Do you think they don't use their contacts within government to make clear that an injustice is being done and to help their clients overcome that injustice?

Sorry if anyone finds the idea of lobbyists or advisors with connections at higher levels of government shocking, but I can guarantee, if you weren't able to bring such pressure and influence to bear, the lower level pencil pushers would be left to work unfettered by common sense, and sometimes, by the strictures of the law they are supposed to be enforcing.