Let me first state i don’t think this is a bad r
Post# of 47018
(Total Views: 543)
Posted On: 08/01/2020 2:40:34 AM
Let me first state i don’t think this is a bad result and my opinion only.. But i agree with TechGuru.. NP himself said as much in the CC and proactive video and what they DIDN’T say is all very telling...
In the call he says this is the hardest population to target.. SK backs him up saying most mild/mods will clear the virus themselves by day 14 hence difficult to compare vs Leron @Day 14.. in this population
In the video.. NP states the purpose of PH2 as exploratory.. where secondary EPs are as important as PEs... very good i appreciate this explanation where he states the FDA isn’t going to NOT give EUA because someone didnt cough less (ha!) whereas it impacts NEWS and shows other benefit vs the virus... compare to remdesivir EUA is good analogy here...
Now.. they probably did cherry pick results... please. it takes time but let me know which stat plan is working Day 3 secondary prior to calculating overall Primary (which arguably the easiest combo of scores)... tell me they aren’t screaming from the mountain tops already if they had that great p-value in the PE...
but no seems they need to make their case for EUA which was always the plan.. FDA wasn’t going to approve based on Ph2 alone.. and i’m fine with it. PH3 bring it on. Hope the severe/critical safety & interim can complete the picture and get us there sooner. but EUA is on the way!
In the call he says this is the hardest population to target.. SK backs him up saying most mild/mods will clear the virus themselves by day 14 hence difficult to compare vs Leron @Day 14.. in this population
In the video.. NP states the purpose of PH2 as exploratory.. where secondary EPs are as important as PEs... very good i appreciate this explanation where he states the FDA isn’t going to NOT give EUA because someone didnt cough less (ha!) whereas it impacts NEWS and shows other benefit vs the virus... compare to remdesivir EUA is good analogy here...
Now.. they probably did cherry pick results... please. it takes time but let me know which stat plan is working Day 3 secondary prior to calculating overall Primary (which arguably the easiest combo of scores)... tell me they aren’t screaming from the mountain tops already if they had that great p-value in the PE...
but no seems they need to make their case for EUA which was always the plan.. FDA wasn’t going to approve based on Ph2 alone.. and i’m fine with it. PH3 bring it on. Hope the severe/critical safety & interim can complete the picture and get us there sooner. but EUA is on the way!
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