$RLFTF FC dd from ya-h-oo (copy)
The Clinical Trial site was officially updated to use Resolution of Respiratory Failure up to 28 days as the primary endpoint. The wording in everyone's mind before this update, I believe, was clear of respiratory failure in 7-10 days. This was why during Dr. J's second interview with Dr. Yo, everyone was so distressed to find out the interim review for 102 patient would be 4 weeks after 9/30 instead of 10 days.
I did a little digging. This version of endpoints has actually been there all along without much of our notice. In the Study Protocol document (dated August 15, 2020) of the EAP(NCT04453839 on ClinicalTrials site), the Statistical Methods section says:
- Primary endpoint: survival over 60 days by Kaplan Meier analysis
- Secondary endpoint: recovery from respiratory failure on cumulative probability distribution
- Secondary endpoint: NIAID 8 point ordinal scale
The first secondary endpoint became the primary endpoint in IV trial, the primary endpoint became the second secondary endpoint. So this change didn't come from the FDA. It has always been in the design of Dr. J's team. Now we can see the EAP and IV trial converge on their endpoints. This isn't revealed until almost the last minute. What a surprise!
A lot can be read into this. Here are my two cents. One is now I understand more what Dr. J meant by 'registration quality' when talking about EAP data. EAP having the same set of main endpoints is one aspect of it. Two is we should now have a pretty good feeling about the trial data. It will follow EAP footstep and will be impressive.
We will soon have two sets of data to support our EUA if the company go ahead and unblind the 102 interim data after full enrollment (102 is at 60 days as well). FDA please give Aviptadil the blessing in a timely manner so it can do its job!
