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Posted On: 07/27/2020 11:55:24 AM
Post# of 36541
So, our 8K says...
Item 8.01 Other Events.
On July 24, 2020, Generex Biotechnology Corporation (“Generex”) was informed by the United States Food & Drug Administration (“FDA”) that Generex’s Pre-IND briefing package for its Ii-Key-SARS-CoV-2 coronavirus prophylactic vaccine was accepted and that the FDA shall provide a written response by August 24, 2020. Due to the significant number of submissions relating to COVID-19, the FDA is only providing written responses rather than conducting face-to-face or teleconferences for Pre-IND meetings.
However, the FDA response says...
We acknowledge receipt of your meeting package submitted on July 17, 2020.
We received your request for Written Responses Only rather than a Face-to-Face meeting or teleconference. CBER is in agreement with this meeting format and will send our Written Responses by August 24, 2020.
So, did we submit for a written response only? GNBT's PR makes it sound like the FDA said they are only doing written responses right now. Rather it looks like GNBT only asked for a written response. I know Joe always says I don't read things correctly, so please let me know if the FDA incorrectly replied in their own letter. Just like the SEC were mistaken and GNBT had responded to all the SEC NGIO Form 10 comment letters.
Item 8.01 Other Events.
On July 24, 2020, Generex Biotechnology Corporation (“Generex”) was informed by the United States Food & Drug Administration (“FDA”) that Generex’s Pre-IND briefing package for its Ii-Key-SARS-CoV-2 coronavirus prophylactic vaccine was accepted and that the FDA shall provide a written response by August 24, 2020. Due to the significant number of submissions relating to COVID-19, the FDA is only providing written responses rather than conducting face-to-face or teleconferences for Pre-IND meetings.
However, the FDA response says...
We acknowledge receipt of your meeting package submitted on July 17, 2020.
We received your request for Written Responses Only rather than a Face-to-Face meeting or teleconference. CBER is in agreement with this meeting format and will send our Written Responses by August 24, 2020.
So, did we submit for a written response only? GNBT's PR makes it sound like the FDA said they are only doing written responses right now. Rather it looks like GNBT only asked for a written response. I know Joe always says I don't read things correctly, so please let me know if the FDA incorrectly replied in their own letter. Just like the SEC were mistaken and GNBT had responded to all the SEC NGIO Form 10 comment letters.
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Disclaimer: Of course, all of this is my opinion and you should not make any investment decisions based on my opinion. I have not received any non-public information.
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