(Total Views: 604)
Posted On: 12/26/2020 9:23:21 PM
Post# of 153925
Re: ClosetInvestor #69724
The wording of the PR describes 2 methods for s/c patients to gain access to Leronlimab:.......the U.S. Food and Drug Administration (“FDA”) provided guidance to the Company
1) "to add an open label EXTENSION to its Phase III trial....."
2) "specific criteria for the CONTINUATION of eINDs...."
"extension of...."
"continuation of...."
(protocols for both already exist)
There shouldn't be a problem for Cytodyn to quickly (Monday) submit protocals which will contain no changes or will contain very minor changes.
It shouldn't take much time for the FDA to approve the protocols that contain very little or no changes from existing protocols.
Maybe the FDA will surprise us with a quick response, since about 1100 Americans die every day of covid.
1) "to add an open label EXTENSION to its Phase III trial....."
2) "specific criteria for the CONTINUATION of eINDs...."
"extension of...."
"continuation of...."
(protocols for both already exist)
There shouldn't be a problem for Cytodyn to quickly (Monday) submit protocals which will contain no changes or will contain very minor changes.
It shouldn't take much time for the FDA to approve the protocols that contain very little or no changes from existing protocols.
Maybe the FDA will surprise us with a quick response, since about 1100 Americans die every day of covid.
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