Wednesday, June 02, 2021 5:04:43 PM
But,
There are Four Significant Data P=values from the COVID CT to discuss about Ifenprodil during the EOP2 FDA Meeting.
Their IND filing said use for ANY impaired lung issue. Could there be some decision that will include a Phase 3 that encompasses ALI etc? That would be a 'marketable' event.
"The decision to file with the U.S. FDA, was made after a recent independent study found that Ifenprodil significantly reduced ALI and improved survivability in an animal study with Asian H5N1 infected mice by 40%. Asian H5N1 is the most lethal form of influenza known to date with an over 50% mortality rate. The drug was also previously shown in a separate study to prolong survival under anoxic (low oxygen) conditions, as might occur in patients with severely impaired lung function."
I would hope that AGN will claim, 'extenuating conditions' / COVID, for the delay / disruption / failure of the IPF/CC Trials in Aus/NZ and the Ifenpodil CT in S Korea. Then use this all as leverage/incentive for a minor redirection in the Phase 3 to focus on 'Lung Impairment'' Long Haulers too for the COVID associations. ALI/CC. Make the IPF just COVID PF. Possible.? IDK...
The existing / new FDA Guidelines were intended to add some flexibilities. JMHO...GLTA....
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