A couple of questions: If CD-12 is done and patie
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Posted On: 04/18/2021 1:02:28 PM
A couple of questions:
If CD-12 is done and patients are not being added to that trial why did the FDA post official notice that CD-12 has been extended to June 2021? What is involved in extending a trial, or leaving it open, if nothing acceptable is taking place? If something acceptable is taking place what do we suppose that acceptable thing is? I suppose it could be just for OLE safety, but how much stat sig safety data is 55-70 patients going to add to well over 1,000 already on the books? Perhaps the FDA is just trying to save a few additional lives while they stall CD-16/17? Nah! Save lives? That couldn't be it.
It seems to me that a number of us are drawing rather strong conclusions based on little to no confirming authoritative information.
But, of course, that appears to be what we do here. So...just another day.
I vote that the FDA will allow the new OLE data and that it will show stat sig, the stock will race to $21.63, a billionaire will fund cancer trials, and the FDA will accept our BLA this summer. That and $12 will buy you a really good Martini.
If CD-12 is done and patients are not being added to that trial why did the FDA post official notice that CD-12 has been extended to June 2021? What is involved in extending a trial, or leaving it open, if nothing acceptable is taking place? If something acceptable is taking place what do we suppose that acceptable thing is? I suppose it could be just for OLE safety, but how much stat sig safety data is 55-70 patients going to add to well over 1,000 already on the books? Perhaps the FDA is just trying to save a few additional lives while they stall CD-16/17? Nah! Save lives? That couldn't be it.
It seems to me that a number of us are drawing rather strong conclusions based on little to no confirming authoritative information.
But, of course, that appears to be what we do here. So...just another day.
I vote that the FDA will allow the new OLE data and that it will show stat sig, the stock will race to $21.63, a billionaire will fund cancer trials, and the FDA will accept our BLA this summer. That and $12 will buy you a really good Martini.
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