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PennyWorld

11/05/22 7:29 PM

#33653 RE: rickstereo3333 #33652

That's exactly with relief did. As the virus evolved and SOC evolved, the FDA permitted them to change the parameters surrounding their primary endpoints. So the situation is similar in that respect. The general thinking (arm chair quarterbacking) is the primary endpoints were too rigid, and the secondary endpoint should have been the primary endpoint.... because there was success with the secondary endpoint. It's all about endpoint design, and 'getting it right'.

Regarding the NIH study and aviptadil, you are incorrect regarding the secondary endpoint. Here is an excerpt...

In this multicenter, randomized, placebo-controlled trial among critically ill patients with COVID-19 and respiratory failure, we did not reach statistical significance (OR, 1.6; 95% CI, 0.86–3.11) on the primary end point of being alive and free of respiratory failure at 60 days. There was a two-fold, statistically significant increased odds of day 60 survival (the key secondary end point) (p = 0.035).


Full study results....
https://journals.lww.com/ccmjournal/Fulltext/2022/11000/The_Use_of_IV_Vasoactive_Intestinal_Peptide.1.aspx?fbclid=IwAR0_feyIsWpE0jFpZASAjg_q5hJxVIT5GApgUYJ5_dqrJODYb8uat4s-RGc