Replies to post #685015 on NorthWest Biotherapeutics Inc (NWBO)

[Steady_T]

FY 2023 and FY 2024 User Fee Rates 
 Fee Category	Fee Rates for FY 2023	Fee Rates for FY 2024 
 Application	 	  
      Requiring clinical data	$3,242,026	$4,048,695 
      Not requiring clinical data	$1,621,013	$2,024,348 
 Program	$393,933	$416,734

Are there any waivers of user fees?

Under section 736(d) of the FD&C Act, a waiver may be granted for one or more user fees where:

A waiver or reduction is necessary to protect the public health;
The assessment of the user fee would present a significant barrier to innovation due to limited resources or other circumstances; or
The applicant involved is a small business submitting its first human drug application to FDA for review.
To be granted a waiver, the human drug applicant must submit a written request for the waiver. Applicants may submit written requests (for both CDER and CBER products) via email to [e-mail].

Is there a user fee for orphan drugs?
Designated Orphan Drug or Indication: An application for a prescription drug product that has been designated as a drug for a rare disease or condition under section 526 of the FD&C Act is not subject to an application fee unless the application includes an indication for other than a rare disease or condition.Dec 14, 2023

[mike00h]

I think you are. US tax payers foot the bill for bureaucracies’ budgets, like the FAA and the FDA. BPs have substantial influence because they rain money on doctors and bureaucrats.
Price of a new drug application is the same, no matter who you are. Edit: except for orphan, as previously posted.
Pretty sure you are right about Charles River Labs. It seems obvious.