No, it cannot be prescribed off the back of a US FDA ODD.
Why?
Because the ODD is a suite of concessions / benefits to assist with / encourage the development of MPL for the treatment of ALS/MND and has nothing to do with approval / authorisation to use the drug (that comes later and is why we are embarking on the Phase 2/3 registration trial). You will see on the ODD portal that it explicitly addreses whether the drug has been approved for use in the nominated disease (the Orphan Indication):
Also, becasue MPL is not currently approved for human use for ANY indication it cannot be prescribed for off-label use.
Hope this clarifies.
Cheers
Densy
No, it cannot be prescribed off the back of a US FDA...
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