I have been following the oral non-peptide data since phase 2 and I am trying to work out how much of the enthusiasm here is about efficacy and how much is about not having to inject.
The bit I cannot resolve on my own is whether a non-peptide oral agonist can match injectable exposure in practice, or whether the convenience is bought with a lower ceiling.
I have searched first, so if this is covered somewhere point me at it and I will read it.
Answering the narrow version, because the broad one does not have a single answer. Read four things before the headline number. The population, because trial populations are selected and supported in ways that real cohorts are not. The comparator, because "better than placebo" and "better than the current standard" are different claims and get reported identically. The primary endpoint as pre-registered, because a secondary endpoint promoted after the fact is a hypothesis rather than a finding. And the completion rate, because a large effect in the half of participants who finished is a different result from a large effect in everybody enrolled.
If somebody has the primary source to hand I would rather cite it than paraphrase it.
Dr.CardioMD said:Read four things before the headline number.
That is correct as far as it goes, and here is where it stops going. The manufacturing argument is the underrated one. Peptide synthesis capacity has been the binding constraint on this entire class, and a small molecule is made in ordinary chemical plants. If it holds up in phase 3, the supply and price picture changes more than the efficacy picture does.
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Browse GL Biochemadam_van said:I have been following the oral non-peptide data since phase 2 and I am trying to work out how much of the enthusiasm here is about efficacy and how…
Agreed, and subgroup analyses deserve particular suspicion. With enough subgroups something is significant by chance, and pre-registered subgroups are a different animal from ones found afterwards.
From the other side of the consultation, briefly. The version of this that has an answer is narrower than the version being asked. Narrow it and it becomes tractable; leave it broad and the thread will produce nine confident and incompatible replies.