“Well now I'm quite concerned again. What in the
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Posted On: 03/24/2021 11:54:47 PM
“Well now I'm quite concerned again. What in the world might a pre*EUA be, sounds almost like a joke?”
If you go back to last summer/fall, and follow the details of the M2M EUA submission, you’ll discover that CYDY didn’t actually file for EUA. Instead, NP asked if EUA for the M2M was possible and the FDA said no. IMO, this saves money on the official application and saves NP from PRing a rejection. I don’t think it’s a “joke” or that you should be concerned, instead, its a creative way of circumventing the typical application and approval/denial process.
Annual Shareholders meeting on September 30th, 2020. At 23:17 NP says that CYDY didn’t get EUA for M2M indication. NP then attempts to clarify that CYDY did apply for EUA for M2M but then goes on to explain that CYDY didn’t want to have a “check mark” on their record so they asked the FDA what they WOULD do if CYDY would’ve applied. Below is the closest word for word interpretation of what NP said based on the YouTube video of the meeting:
“We did apply for it please note we did apply for it with the FDA. We asked them but we didn’t want a check mark on our record so we said before you put that rejected can you just tell us what you’re going to do before you do it, and they did.”
https://www.cytodyn.com/newsroom/press-releas...ockholders
Link to video of meeting:
https://youtu.be/uyf49Ld4Hno
If you go back to last summer/fall, and follow the details of the M2M EUA submission, you’ll discover that CYDY didn’t actually file for EUA. Instead, NP asked if EUA for the M2M was possible and the FDA said no. IMO, this saves money on the official application and saves NP from PRing a rejection. I don’t think it’s a “joke” or that you should be concerned, instead, its a creative way of circumventing the typical application and approval/denial process.
Annual Shareholders meeting on September 30th, 2020. At 23:17 NP says that CYDY didn’t get EUA for M2M indication. NP then attempts to clarify that CYDY did apply for EUA for M2M but then goes on to explain that CYDY didn’t want to have a “check mark” on their record so they asked the FDA what they WOULD do if CYDY would’ve applied. Below is the closest word for word interpretation of what NP said based on the YouTube video of the meeting:
“We did apply for it please note we did apply for it with the FDA. We asked them but we didn’t want a check mark on our record so we said before you put that rejected can you just tell us what you’re going to do before you do it, and they did.”
https://www.cytodyn.com/newsroom/press-releas...ockholders
Link to video of meeting:
https://youtu.be/uyf49Ld4Hno
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