ER,
I'm thinking there's some confusion as to what was sent to the FDA. I'm thinking there's a very oddly worded Freedom of Information Act (FOIA) request sent back in Jan 2021. I think it was denied a response in Feb 2021.
Request is in this spreadsheet published on FDA's FOIA Logs under Control # 2021-266:
https://www.fda.gov/media/145544/download
The Request Denied status is reflected here:
https://www.fda.gov/media/146336/download
No reason for the "Request Denied" status.
I just find the wording odd in the request:
The wording sounds like something you would submit to the SEC for a FOIA request. Why would you say that to the FDA when requesting FDA related information...
Sounds like someone with a bone to pick with the company....and not a positive one....
FYI: I did not see any requests by this name elsewhere in the FDA FOIA request logs, nor the SEC's logs. Hopefully they got it off their chest and didn't let it eat at their soul enough to go on a blind rampage trying to destroy people's reputations or a company's publicly traded stock by making false and misleading statements on a public forum when invested in a potentially hostile organization attempting a control takeover of CytoDyn.....
....that wouldn't be good form....
[late add] I hope everyone realizes that all these documents the US Government receives and responds to is public information...with the exception of Personally Identifiable Information.
I'm thinking there's some confusion as to what was sent to the FDA. I'm thinking there's a very oddly worded Freedom of Information Act (FOIA) request sent back in Jan 2021. I think it was denied a response in Feb 2021.
Request is in this spreadsheet published on FDA's FOIA Logs under Control # 2021-266:
https://www.fda.gov/media/145544/download
The Request Denied status is reflected here:
https://www.fda.gov/media/146336/download
No reason for the "Request Denied" status.
I just find the wording odd in the request:
Quote:The product at issue is a drug (not approved yet, still in clinics trials). The name of the drug is leronlimab, formerly pro-140. On August 17th, 2020, Cytodyn released a PR stating that the company had filed for Emergency Use Authorization (EUA) with the FDA for the COVID19 mild to moderate population using the data from their completed COVID19 M2M trial (CD10_COVID-19 or NCT04343651). I have reason to believe that Cytodyn misled investors and that the company did not file an EUA for the M2M indication. If possible, I would like a copy of the EUA filed by Cytodyn or if that?s not an option, an acknowledgment from the FDA that the organization either received the EUA from Cytodyn or that you didn?t receive the EUA.
The wording sounds like something you would submit to the SEC for a FOIA request. Why would you say that to the FDA when requesting FDA related information...
Quote:I have reason to believe that Cytodyn misled investors
Sounds like someone with a bone to pick with the company....and not a positive one....
FYI: I did not see any requests by this name elsewhere in the FDA FOIA request logs, nor the SEC's logs. Hopefully they got it off their chest and didn't let it eat at their soul enough to go on a blind rampage trying to destroy people's reputations or a company's publicly traded stock by making false and misleading statements on a public forum when invested in a potentially hostile organization attempting a control takeover of CytoDyn.....
....that wouldn't be good form....
[late add] I hope everyone realizes that all these documents the US Government receives and responds to is public information...with the exception of Personally Identifiable Information.
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