Apologies if someone posted about this already, bu
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Posted On: 08/20/2020 2:49:45 PM
Apologies if someone posted about this already, but I recently watched the Dr Yo interview with Dr. Jonathan Javitt of Aviptadil (VIP).
I found it interesting that Aviptadil also stopped their EIND program recently at the FDAs request, however, they were allowed to setup an intermediate size population expanded access program to run concurrently with the double blind trials.
https://www.youtube.com/watch?v=KBG_BYfj-sY (@33:22)
Other than sharing conspiracy theories, does anyone here have any reasonable explanation why an expanded access program wasn't done with Leronlimab? VIP is a naturally occurring substance but a synthetic version has yet to be approved as a drug.
Perhaps it's simply due to the FDA being more familiar with VIP.
I found it interesting that Aviptadil also stopped their EIND program recently at the FDAs request, however, they were allowed to setup an intermediate size population expanded access program to run concurrently with the double blind trials.
https://www.youtube.com/watch?v=KBG_BYfj-sY (@33:22)
Other than sharing conspiracy theories, does anyone here have any reasonable explanation why an expanded access program wasn't done with Leronlimab? VIP is a naturally occurring substance but a synthetic version has yet to be approved as a drug.
Perhaps it's simply due to the FDA being more familiar with VIP.
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