"a misstatement by the Dr. (Seethamraju)".
A misstatement by Dr. Seethamraju seems to me the most unlikely possibility of all.
Many posters here decried Dr. Seethamraju's rather subdued, perhaps even milquetoast delivery on Oct 7.
Looks to me like "No he's not Superman, that's just Clark Kent".
Seethamraju is doing stuff that no one else does, maybe no one else has ever done.
Has anyone else ever bulldozed the FDA into an EIND not only without any preclinical studies, but even in the face of the FDA scientists' belief that the drug has no relevance to the disease?
And if that wasn't enough already, Dr. Seethamraju just casually tosses "the FDA is reviewing unblinded CD12 data" into his Oct 7 presentation.
The whole rest of Seethamraju's Oct 7 presentation was old data. Seethamraju has lots and lots of new data that has never been released. It might be difficult for him to make his slides without accidentally dropping in some new data.
But there was no new data.
Except for "the FDA is reviewing unblinded CD12 data".
And even Seethamraju's choice of words seems telling to me.
Seethamraju doesn't say "the FDA is reviewing the interim analysis."
Seethamraju says the "the FDA is reviewing unblinded data".
I think Seethamraju is saying that the FDA is reviewing all the CD12 data, not just the 195 patients in the interim analysis.
If the FDA is contemplating major action, why would they restrict themselves to less than 100% of the pateints?
I believe they are not only reviewing all the patients in CD12, but also everything in CD10. And I believe the FDA is also reviewing HIV and cancer for safety information towards the purpose of assessing the "risk benefit" that Hahn spoke of.
Seethamraju's Oct 7 comment that "the FDA is reviewing unblinded CD12 data" raises all sorts of other odd questions.
Upon whose initiative was the FDA CD12 unblinded data review intitiated? Did the FDA take it upon themselves?
And how does Seethamraju know that the FDA is reviewing CD12 data? Under what protocol and authority does Seethamraju have acces to that information?
And perhaps most astonishingly, under what protocol and authority is Seethamraju permitted to reveal that "the FDA is reviewing CD12 data"?
The FDA CD12 review of unblinded data is highly unusual just by itself.
Seethamraju's reveal of the FDA's unusual action may be unprecedented.
Perhaps Seethamraju is the big dog on this street.
A misstatement by Dr. Seethamraju seems to me the most unlikely possibility of all.
Many posters here decried Dr. Seethamraju's rather subdued, perhaps even milquetoast delivery on Oct 7.
Looks to me like "No he's not Superman, that's just Clark Kent".
Seethamraju is doing stuff that no one else does, maybe no one else has ever done.
Has anyone else ever bulldozed the FDA into an EIND not only without any preclinical studies, but even in the face of the FDA scientists' belief that the drug has no relevance to the disease?
And if that wasn't enough already, Dr. Seethamraju just casually tosses "the FDA is reviewing unblinded CD12 data" into his Oct 7 presentation.
The whole rest of Seethamraju's Oct 7 presentation was old data. Seethamraju has lots and lots of new data that has never been released. It might be difficult for him to make his slides without accidentally dropping in some new data.
But there was no new data.
Except for "the FDA is reviewing unblinded CD12 data".
And even Seethamraju's choice of words seems telling to me.
Seethamraju doesn't say "the FDA is reviewing the interim analysis."
Seethamraju says the "the FDA is reviewing unblinded data".
I think Seethamraju is saying that the FDA is reviewing all the CD12 data, not just the 195 patients in the interim analysis.
If the FDA is contemplating major action, why would they restrict themselves to less than 100% of the pateints?
I believe they are not only reviewing all the patients in CD12, but also everything in CD10. And I believe the FDA is also reviewing HIV and cancer for safety information towards the purpose of assessing the "risk benefit" that Hahn spoke of.
Seethamraju's Oct 7 comment that "the FDA is reviewing unblinded CD12 data" raises all sorts of other odd questions.
Upon whose initiative was the FDA CD12 unblinded data review intitiated? Did the FDA take it upon themselves?
And how does Seethamraju know that the FDA is reviewing CD12 data? Under what protocol and authority does Seethamraju have acces to that information?
And perhaps most astonishingly, under what protocol and authority is Seethamraju permitted to reveal that "the FDA is reviewing CD12 data"?
The FDA CD12 review of unblinded data is highly unusual just by itself.
Seethamraju's reveal of the FDA's unusual action may be unprecedented.
Perhaps Seethamraju is the big dog on this street.
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