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Posted On: 03/22/2021 10:11:09 AM
Post# of 148870
Re: Number1Stocker #83829
Awesome find NumberOneStocker--
For those of you who didn't check out the link, here's the quote from the "History of Changes" section of the clinicaltrials.gov website for the CD12 trial (NCT04347239)
"A single arm, non-randomized, open-label phase is added to the protocol after completion of enrollment in the Randomized Phase of the study"
So, does this mean the FDA is not requiring CD16? That's one interpretation anyway!
Why would you do a new trial for basically the same indication if you are providing an OLE for the earlier trial?
I'm not the only one on this board who's wondered about the ethical implications of doing a randomized CD16 while concurrently providing an EUA for leronlimab. But an EUA is quite compatible with an OLE with no placebo arm/acess to LL for all participants.
When we didn't hit our endpoints I was resigned to a long slog of several months to complete a CD16 trial... But this OLE for CD12 is very encouraging. Not to mention the promising if anecdotal hints from the Long Haulers trial.
Two good reasons to be excited for the CC this afternoon.
For those of you who didn't check out the link, here's the quote from the "History of Changes" section of the clinicaltrials.gov website for the CD12 trial (NCT04347239)
"A single arm, non-randomized, open-label phase is added to the protocol after completion of enrollment in the Randomized Phase of the study"
So, does this mean the FDA is not requiring CD16? That's one interpretation anyway!
Why would you do a new trial for basically the same indication if you are providing an OLE for the earlier trial?
I'm not the only one on this board who's wondered about the ethical implications of doing a randomized CD16 while concurrently providing an EUA for leronlimab. But an EUA is quite compatible with an OLE with no placebo arm/acess to LL for all participants.
When we didn't hit our endpoints I was resigned to a long slog of several months to complete a CD16 trial... But this OLE for CD12 is very encouraging. Not to mention the promising if anecdotal hints from the Long Haulers trial.
Two good reasons to be excited for the CC this afternoon.
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