Saturday, November 07, 2020 6:27:50 PM
r_deckard...thank you for sharing the full article. I found the last sentence very interesting, especially the part bolded:
"He also assumes that the increase in the targeted number of patients from 144 to 165 is an indication of an initially less pronounced data trend. Selvaraju replied that the early termination of the study was a hurdle that was extremely difficult to overcome. The increase in the number of study participants had been encouraged by the U.S. Food and Drug Administration (FDA) even before the first interim analysis.
It seems like the analyst, Olav, wasn't able to fully appreciate Relief's drug and how it impacts both VPAC 1 & 2. Also, this same analyst isn't convinced the 2nd interim analysis was as effective as the first and thus the basis for his article. I liked how Ram stated the FDA wanted the increased number of patients in the trial and this was known before the first interim analysis was even done. That is reassuring.
At the end of the day, it doesn't sound like this drug is a stinker. So now we wait to see if it helps a little or a lot for critical patients. It will be amazing if the impacts are even bigger on healthier patients just presenting with Covid.
Have a nice weekend all.
Dave
"He also assumes that the increase in the targeted number of patients from 144 to 165 is an indication of an initially less pronounced data trend. Selvaraju replied that the early termination of the study was a hurdle that was extremely difficult to overcome. The increase in the number of study participants had been encouraged by the U.S. Food and Drug Administration (FDA) even before the first interim analysis.
It seems like the analyst, Olav, wasn't able to fully appreciate Relief's drug and how it impacts both VPAC 1 & 2. Also, this same analyst isn't convinced the 2nd interim analysis was as effective as the first and thus the basis for his article. I liked how Ram stated the FDA wanted the increased number of patients in the trial and this was known before the first interim analysis was even done. That is reassuring.
At the end of the day, it doesn't sound like this drug is a stinker. So now we wait to see if it helps a little or a lot for critical patients. It will be amazing if the impacts are even bigger on healthier patients just presenting with Covid.
Have a nice weekend all.
Dave
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