“Great point JLang. NP told us all that he did not apply for EUA in m-m because FDA advised him not to bother.”
This is only partially true. NP PRed that CYDY filed for M2M EUA, mentioned that CYDY was waiting for a response to the EUA, and then finally, a few weeks later, admitted that CYDY didn’t actually file for EUA. He explained that CYDY only asked the FDA IF EUA was possible and didn’t officially fail because he didn’t want another “check” against CYDY by the FDA. See below for how the M2M “EUA” unfolded.
M2M Safety Data PR, July 21st, 2020 - https://www.cytodyn.com/newsroom/press-releas...d-19-trial
M2M Safety Data PR (revised version) released 5 hours later than the original, July 21st, 2020 - https://www.cytodyn.com/newsroom/press-releas...ns-phase-2
M2M Trial Topline Data PR, August 11th, 2020, - In this PR, NP says the company will make a case for immediate approval in the M2M population using the M2M data. https://www.cytodyn.com/newsroom/press-releas...ne-results
M2M request for EUA filed with FDA, August 17th, 2020 - This PR states in the first paragraph that CYDY requested EUA with the FDA for the M2M with the data from the M2M trial. https://www.cytodyn.com/newsroom/press-releas...ts-phase-2
Conference Call on September 2nd, 2020 at the 0735 mark, NP states that CYDY inquired about their FDA M2M EUA application and that the FDA responded by saying the decision is forth coming.
https://www.cytodyn.com/newsroom/press-releas...to-provide
Conference Call on September 16th, 2020, at the 1930 mark, NP says in regards to the M2M EUA, that the FDA would like to see interim results from the S/C trial. https://www.cytodyn.com/newsroom/press-releas...to-provide
Conference call on September 16th, 2020, at the 59:25 mark, NP states that the M2M indication is not going to receive an EUA and that the FDA recommended CYDY not to “file”. This was followed by NP saying, “we haven’t filed officially yet.” This comment is in stark contrast to the PR on August 17th that states CYDY filed for EUA for the M2M indication.
https://www.cytodyn.com/newsroom/press-releas...to-provide
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 is 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
This is only partially true. NP PRed that CYDY filed for M2M EUA, mentioned that CYDY was waiting for a response to the EUA, and then finally, a few weeks later, admitted that CYDY didn’t actually file for EUA. He explained that CYDY only asked the FDA IF EUA was possible and didn’t officially fail because he didn’t want another “check” against CYDY by the FDA. See below for how the M2M “EUA” unfolded.
M2M Safety Data PR, July 21st, 2020 - https://www.cytodyn.com/newsroom/press-releas...d-19-trial
M2M Safety Data PR (revised version) released 5 hours later than the original, July 21st, 2020 - https://www.cytodyn.com/newsroom/press-releas...ns-phase-2
M2M Trial Topline Data PR, August 11th, 2020, - In this PR, NP says the company will make a case for immediate approval in the M2M population using the M2M data. https://www.cytodyn.com/newsroom/press-releas...ne-results
M2M request for EUA filed with FDA, August 17th, 2020 - This PR states in the first paragraph that CYDY requested EUA with the FDA for the M2M with the data from the M2M trial. https://www.cytodyn.com/newsroom/press-releas...ts-phase-2
Conference Call on September 2nd, 2020 at the 0735 mark, NP states that CYDY inquired about their FDA M2M EUA application and that the FDA responded by saying the decision is forth coming.
https://www.cytodyn.com/newsroom/press-releas...to-provide
Conference Call on September 16th, 2020, at the 1930 mark, NP says in regards to the M2M EUA, that the FDA would like to see interim results from the S/C trial. https://www.cytodyn.com/newsroom/press-releas...to-provide
Conference call on September 16th, 2020, at the 59:25 mark, NP states that the M2M indication is not going to receive an EUA and that the FDA recommended CYDY not to “file”. This was followed by NP saying, “we haven’t filed officially yet.” This comment is in stark contrast to the PR on August 17th that states CYDY filed for EUA for the M2M indication.
https://www.cytodyn.com/newsroom/press-releas...to-provide
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 is 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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