Data collection for CD12 severe/critical "interim
Post# of 155517
(Total Views: 659)
Posted On: 09/19/2020 1:52:22 PM
Re: Boatbuilder #56996
Data collection for CD12 severe/critical "interim analysis" of 195 patients is full stop on Tuesday, Sept 22, 3 days from now.
Tuesday, Sept 22, will be 28 days after the 195th patient was enrolled.
Of course if patient #195 was dosed the day after he was enrolled, then the Sept 22 date could push out a day or two.
28 day mortality is the primary endpoint.
It wont take long to see which of those 195 patients are dead or alive at day 28 and which received Ll or standard of care.
Pass/fail numerical endpoints have likely already been decided. So its just count and compare to the list for the 28 day mortality primary endpoint.
If the primary endpoint is squishy, then it will take weeks to analyze the secondary endpoints cuz they are more complicated.
Maybe even with strong results on the primary, they will take weeks to say anything in order to develop the secondary endpoint results as additional support, given what appears to be generally slow action by the FDA.
Tuesday, Sept 22, will be 28 days after the 195th patient was enrolled.
Of course if patient #195 was dosed the day after he was enrolled, then the Sept 22 date could push out a day or two.
28 day mortality is the primary endpoint.
It wont take long to see which of those 195 patients are dead or alive at day 28 and which received Ll or standard of care.
Pass/fail numerical endpoints have likely already been decided. So its just count and compare to the list for the 28 day mortality primary endpoint.
If the primary endpoint is squishy, then it will take weeks to analyze the secondary endpoints cuz they are more complicated.
Maybe even with strong results on the primary, they will take weeks to say anything in order to develop the secondary endpoint results as additional support, given what appears to be generally slow action by the FDA.
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