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Posted On: 09/04/2020 8:12:05 AM
Post# of 145881
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The clinical trial of Remdesiver was halted early due to the fact that it would be unethical to continue the placebo arm of the trial(that was my first clue things were a little odd). I'm sure we all feel the same way about that determination(AF, et al excluded). My first question is in regards to cydy's cd-12 and the safety monitoring...Do they operate according to their own criteria or is it based on any of the endpoints?
Based on info reported so far (from cd-10 and eind patient results) LL's effect is robust very soon after the first injection (72hrs). With that in mind or perhaps at the sponsor's request, wouldn't the safety board be ethically bound to check the efficacy after the 195 patient reached day 3? My argument for that is obvious. Based on at least some of the secondary endpoints, patients could easily have statistically significant improvement by day 3. Likewise 3 days is also long enough for pts given placebo to worsen or show no improvement...in which case all patients would/should be given LL. If that sounds reasonable to many of you, shouldn't someone mention that to someone of authority to perhaps check into that possibility. I don't think I'm totally way off on this. (I would not make the same argument for m/m patients however. Their course is much less predictable for the most part.) If my assertion is reasonable, a determination could be made immediately, I believe?
Based on info reported so far (from cd-10 and eind patient results) LL's effect is robust very soon after the first injection (72hrs). With that in mind or perhaps at the sponsor's request, wouldn't the safety board be ethically bound to check the efficacy after the 195 patient reached day 3? My argument for that is obvious. Based on at least some of the secondary endpoints, patients could easily have statistically significant improvement by day 3. Likewise 3 days is also long enough for pts given placebo to worsen or show no improvement...in which case all patients would/should be given LL. If that sounds reasonable to many of you, shouldn't someone mention that to someone of authority to perhaps check into that possibility. I don't think I'm totally way off on this. (I would not make the same argument for m/m patients however. Their course is much less predictable for the most part.) If my assertion is reasonable, a determination could be made immediately, I believe?
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