MisterBlues schreef op 9 september 2020 08:31:Zorgwekkend en actueel: waar blijft het nieuws over de 104 patiënten critical group?
This has been discussed a lot but I think the IV study should have already completed the 104 patients needed for interim review by the data management committee. I am concerned because if this is true, and if the data is as overwhelmingly positive as we think and hope, the FDA should have stopped the study by now. The fact that that hasn't happened is a bit troubling. Any thoughts on where I might be wrong?
The results may have been statistically significant with say a p value of 0.01 (a p value <0.05 is typically considered statistically significant). However, the FDA may want to wait a week or 2 in order for Aviptadil to demonstrate an even greater level o statistical significance. The FDA knows what a flood of demand their approval will cause.
Wat doen jullie? Verkopen? Een gedeelte?