For the doubters about the press I spoke of:
I have submitted the following request to FDA as part of the Freedom of Information Act. Also, requested expedited processing and selected the ‘Demonstrated urgency to inform public’ category as part of the request:
Hi,
FDA issued a statement on Leronlimab dated May 17, 2021. I would like to get the following information regarding this statement:
1. Name of the person(s) who decided and approved the publication of this statement along with the date when this decision was taken.
2. Name of the author(s), their titles, and the date this was drafted.
3. Name of the reviewer(s), their titles, and the date this was reviewed.
4. Name of the persons(s) who decided to not include the following points: CD-10 mild to moderate meeting the NEWS2 endpoint, 14-day mortality pre-established secondary endpoints of the CD12.
5. Name of the Approver(s), their titles, and the date this was approved for publication.
6. As FDA shared confidential information regarding ongoing trials, did it take any kind of approvals from Cytodyn before publishing the statement? If yes, then when this approval was taken and if not, then why no approval was taken from the company?
7. Did FDA share this statement with Cytodyn before publishing it? If yes, then when was it shared, and if not why was this not shared?
Disclaimer: The requestor has absolutely no connection with Cytodyn or its management. The request is being made on behalf of the public as we feel that the statement was biased, incomplete, and was based on selected data to demonstrate negative aspects of Leronlimab and ignoring all the positives.
Please feel to contact me for any additional information.
Thanks for your help in the matter.
