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Posted On: 01/05/2022 11:36:30 AM
Post# of 148878
Agree, a little confusing and disappointing.
Great that we met primary endpoint with open label 350 vs. randomized placebo group, but if we unblinded and have the data for the placebo group, why not report on the 700 mg results at the same time?
Based on past history, a pessimistic (but perhaps realistic) take is that 700 mg did *not* meet the primary endpoint, so they just didn't report it yet until they can look at some biomarkers and perhaps spin it as positive.
Perhaps they really didn't look at the 700 mg numbers yet, but they did unblind and get the placebo numbers, so it's not clear why they didn't look at and report 700 mg with this PR.
It's also unclear (trying not to be too critical but it's hard!) why they would say in the title that the secondary endpoint was met, but then in the text of the PR say it "reached near significance"? Final confusing point was the ITT vs PP groups. I think they do clarify eventually that they met PE in ITT and PP, but SE only in PP, but it's not clear from the title or first paragraph. Don't mean to nitpick too much, but this should have been stated up front: "Hitting our primary endpoint in both ITT and per protocol (PP) and secondary endpoint in PP" so it isn't confusing.
So, yes, very Naderite still despite Recknor apparently running the show.
We will get a full explanation in time, but in the interim just have to make some assumptions on why they only report certain things. Frustrating and confusing.
Hopefully a top-line report coming soon will clarify everything. Let's see some numbers so we can figure out what they are saying!
Great that we met primary endpoint with open label 350 vs. randomized placebo group, but if we unblinded and have the data for the placebo group, why not report on the 700 mg results at the same time?
Based on past history, a pessimistic (but perhaps realistic) take is that 700 mg did *not* meet the primary endpoint, so they just didn't report it yet until they can look at some biomarkers and perhaps spin it as positive.
Perhaps they really didn't look at the 700 mg numbers yet, but they did unblind and get the placebo numbers, so it's not clear why they didn't look at and report 700 mg with this PR.
It's also unclear (trying not to be too critical but it's hard!) why they would say in the title that the secondary endpoint was met, but then in the text of the PR say it "reached near significance"? Final confusing point was the ITT vs PP groups. I think they do clarify eventually that they met PE in ITT and PP, but SE only in PP, but it's not clear from the title or first paragraph. Don't mean to nitpick too much, but this should have been stated up front: "Hitting our primary endpoint in both ITT and per protocol (PP) and secondary endpoint in PP" so it isn't confusing.
So, yes, very Naderite still despite Recknor apparently running the show.
We will get a full explanation in time, but in the interim just have to make some assumptions on why they only report certain things. Frustrating and confusing.
Hopefully a top-line report coming soon will clarify everything. Let's see some numbers so we can figure out what they are saying!
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