I sent this question to Pourhassan and Kelly, but I would be interested in everyone's take on it. This board has a lot of knowledgeable investors. Thanks.
The FDA has updated its guidelines for therapeutic trials. They are now recognizing that judging mortality benefit at 28 days for critical patients is not an accurate picture due to improvements in standard of care. They are recommending following patients for 60 days. See Page 12: COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry. https://www.fda.gov/media/137926/download
"In a trial in severe and/or critically ill patients, examples of appropriate endpoints could be: All-cause mortality at an appropriate time point (e.g., at least 28 days for hospitalized noncritically ill patients, 60 days for critically ill patients ). "
NeuroRX is trialing RLF-100 (Aviptadil) and completed their trial around the same time we did. After unblinding, the FDA allowed them to modify both their primary endpoint and secondaries to allow for 60 days . Here is their PR about it. https://www.neurorxpharma.com/press-releases/...gh-flow-n/
On February 23, 2021 they updated their trial protocol. As you can see, 28 days became the “interim" and "day 60” was added to a majority of their endpoints . See comparison here: https://clinicaltrials.gov/ct2/history/NCT043...udyPageTop
Rather than start again with new patients, why aren’t we asking the FDA to add 60 days to our endpoints? Wouldn’t all of our data be more meaningful and significant at the 60 day point? This would capture the SOC patients that were severe and ended up critical or relapsing as well. That would give us a much broader picture of Leronlimab’s efficacy. Since we already are accumulating that data, wouldn’t that be better and quicker than starting a new group? Can we ask the FDA to do this?
Can we make our case directly to Woodcock? She has repeatedly said that P value is not as important for the severe/critical patients during a pandemic and that an EUA will not require it.
The FDA has updated its guidelines for therapeutic trials. They are now recognizing that judging mortality benefit at 28 days for critical patients is not an accurate picture due to improvements in standard of care. They are recommending following patients for 60 days. See Page 12: COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry. https://www.fda.gov/media/137926/download
"In a trial in severe and/or critically ill patients, examples of appropriate endpoints could be: All-cause mortality at an appropriate time point (e.g., at least 28 days for hospitalized noncritically ill patients, 60 days for critically ill patients ). "
NeuroRX is trialing RLF-100 (Aviptadil) and completed their trial around the same time we did. After unblinding, the FDA allowed them to modify both their primary endpoint and secondaries to allow for 60 days . Here is their PR about it. https://www.neurorxpharma.com/press-releases/...gh-flow-n/
On February 23, 2021 they updated their trial protocol. As you can see, 28 days became the “interim" and "day 60” was added to a majority of their endpoints . See comparison here: https://clinicaltrials.gov/ct2/history/NCT043...udyPageTop
Rather than start again with new patients, why aren’t we asking the FDA to add 60 days to our endpoints? Wouldn’t all of our data be more meaningful and significant at the 60 day point? This would capture the SOC patients that were severe and ended up critical or relapsing as well. That would give us a much broader picture of Leronlimab’s efficacy. Since we already are accumulating that data, wouldn’t that be better and quicker than starting a new group? Can we ask the FDA to do this?
Can we make our case directly to Woodcock? She has repeatedly said that P value is not as important for the severe/critical patients during a pandemic and that an EUA will not require it.
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