I hear what you and Dr.Acula are saying and I agree with it in normal times. IMO COVID created an exception to the norm and I don't have an issue with COVID trials that only conduct a P3 trial changing the primary endpoint IF it is proven safe AND shows statistically significant benefits for patients. The only reason I am okay with changing the PE is simply due to getting a safe and effective drug available for patients as soon as possible. If safety or efficacy is questionable then continue trials until proven one way or another.....btw "trending" in the right direction with questionable safety profile shouldn't make the cut for EUA or any approval IMO. It is obvious with COVID increasing that remdesivir has little to zero benefit for patients. Changing the PE, doesn't mean the approval criteria should not be changed (safety and stat significant efficacy)….and I understand changing the PE moves the goal posts, but that doesn't mean the football doesn't have to still go through it to score 3 points. The same rules should apply to all companies (now it's time for me to wake up and get back to reality).
Let's see what news we get between now and the CC. Have a great weekend.
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Category: StocksTotal Views: 65 By : EditorUpdated: 05-05-2024
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Company Profile
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Category: InvestingTotal Views: 231 By : EditorUpdated: 05-04-2024
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Category: MarketsTotal Views: 174 By : EditorUpdated: 05-04-2024
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Company Profile
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