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exwannabe

04/15/24 9:51 AM

#685222 RE: manibiotech #685215

Actually that raises an interesting question : has MHRA ever allowed a drug in specials program and then denied approval ?


A better question would be if a drug used in "Specials" has ever been approved? I suspect the answer is either no, or very very few.

The program is not designed for drugs in trials. It is designed for drugs that would never be approved because they are for patients with "special" needs. Most are just reformulations of approved drugs where they patient would be allergic to the approved version.