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Posted On: 12/29/2020 1:35:37 PM
Post# of 154852
CDiddy,
I believe you are correct on both points. Cytodyn PRed that they given guidance on open label extension, but not approved yet that we have been told.
Open label have some small value. However, we have seen therapeutics appearing beneficial in case matched/open label administration that failed rigorous trials.
My understanding is that open label studies are typically proof of concept followed by rigorous trials.
The open label extensions and eIND IMO are an effort by FDA, apparently believing leronlimab is in fact effective, to allow more patients access in advance of the EUA/approval after CD12.
Thank you for addressing my lack of clarity. Plenty of confusion and obfuscation from buyersstrike and the like without my adding to it.
I believe you are correct on both points. Cytodyn PRed that they given guidance on open label extension, but not approved yet that we have been told.
Open label have some small value. However, we have seen therapeutics appearing beneficial in case matched/open label administration that failed rigorous trials.
My understanding is that open label studies are typically proof of concept followed by rigorous trials.
The open label extensions and eIND IMO are an effort by FDA, apparently believing leronlimab is in fact effective, to allow more patients access in advance of the EUA/approval after CD12.
Thank you for addressing my lack of clarity. Plenty of confusion and obfuscation from buyersstrike and the like without my adding to it.
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