The compassionate use program has been in place long enough to show its impact on patients.
How can they possibly leverage the Specials program?
Though being called compassionate access, the program is basically for patients that have a special need and therefore the drug (and formulation) they need is not worth it for any company to take through approval because there is not a sufficient market. The classic case is a formulation that changes the non active ingredients to avoid allergic reactions.
This MHRA FAQ states clearly the Specials program is NOT for drugs in the approval process .
1.6 The exemption and this guidance does not apply to other unlicensed medicinal products, for example: ... investigational medicinal products
NWBO gets away with bending these rules by claiming what is being provided in Specials is NOT mercidencel. That makes using that data a bit difficult.
Market Data 
Markets 
