It is my understanding that CytoDyn is not provi
Post# of 153832
(Total Views: 728)
Posted On: 09/03/2022 10:58:20 PM
It is my understanding that CytoDyn is not providing leron under either Right to Try or Expanded Access (FDA Project Facilitate, AKA Compassionate Use). A loved one in a bad way- is finally ready to consider leron after years of my pleading.
Two questions - for those folks in-the-know:
1) Is this based on the FDA clinical holds? More importantly: Can we expect that to change when the FDA hold is lifted?
2) Does anyone have experience with FDA's Project Facilitate?
(Interesting sentence on National Center for Biotechnology Information website about it:
"A pharmaceutical manufacturer still has to approve access for the patient, but if access is denied, the FDA will inquire as to why it was not granted." Now wouldn't that be something to see... for FDA - after all the blockades - to approach CytoDyn and ask why they aren't providing....
Many TIA- CGC
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