[Results] 79 weeks, 21kg, and non-peptide was the hard part
79 weeks, 21kg, and non-peptide was the hard part, and the part I actually want to talk about is at the bottom. Numbers, in the order they matter: 79 weeks and 21kg. Analytically this is a small-molecule identity and purity problem, not a peptide one. The methods, the impurity classes and the reference standards are…
Corrected a cross-class dose comparison in the title. The body is untouched.
Nothing containing this compound is approved by any regulator, and research-use-only material is not approved for human use.
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ATTAIN and ACHIEVE are the programmes to keep straight
Nothing containing this compound is approved by any regulator, and research-use-only material is not approved for human use.
This is the fact the whole board hangs on. Small molecule, not peptide.
Agreed that phase 3 is where the comparison becomes fair. Everything before it is inference.
the boards keep comparing it to injectables at matched doses, which is meaningless
the tolerability profile reads broadly similar to the class
Daily rather than weekly sounds trivial until you think about what a missed dose means in each case.
daily dosing changes adherence in both directions
small molecule, not a peptide, and that changes everything about it
oral and non-peptide is the whole engineering story
Cosigning on daily dosing. It changes the exposure profile and it changes adherence, in both directions.
do not assume reconstitution intuitions apply, there is nothing to reconstitute
Correction: that is the oral peptide product, which is a different thing entirely. This one is a small molecule.