Interesting thoughts, from Jay at YMB: Jay "
Post# of 154835
(Total Views: 767)
Posted On: 12/02/2021 10:04:34 AM
Interesting thoughts, from Jay at YMB:
Jay
"On May 18, 2021 Cytodyn provided a press release that it was submitting topline data of the CD12 trial to regulatory agencies in Phillippines. Cytodyn recently just submitted the CMC and Non-Clinical modules of HIV BLA to US FDA. I would assume these modules would serve as the foundation for any indication and not just for HIV. Hypothetically, if Cytodyn would have submitted both of these modules to the Phillippines FDA, then the regulatory agency will have the CMC, administrative items, and clinical data from CD12. Based on the statistically significant critical subgroup analysis of the COVID trial paired with all of the treated patients in Phillippines that used Leronlimab, what else would the regulatory agency in Phillippines need for an EUA at this point. (Outside of an approval from another country).
Remember, there was a conversation on a Phillippines conference call with NP, SK, and Recknor present.
NP said that Recknor was preparing all of the modules to give to the Phillippines FDA / Chiral...in order to submit for an application for an EUA in that country. This occurred in the early summertime, I believe. Keep in mind that since this webcast....Cytodyn has treated a number of patients in this country which provide further data to strengthen the case for an EUA."
Jay
"On May 18, 2021 Cytodyn provided a press release that it was submitting topline data of the CD12 trial to regulatory agencies in Phillippines. Cytodyn recently just submitted the CMC and Non-Clinical modules of HIV BLA to US FDA. I would assume these modules would serve as the foundation for any indication and not just for HIV. Hypothetically, if Cytodyn would have submitted both of these modules to the Phillippines FDA, then the regulatory agency will have the CMC, administrative items, and clinical data from CD12. Based on the statistically significant critical subgroup analysis of the COVID trial paired with all of the treated patients in Phillippines that used Leronlimab, what else would the regulatory agency in Phillippines need for an EUA at this point. (Outside of an approval from another country).
Remember, there was a conversation on a Phillippines conference call with NP, SK, and Recknor present.
NP said that Recknor was preparing all of the modules to give to the Phillippines FDA / Chiral...in order to submit for an application for an EUA in that country. This occurred in the early summertime, I believe. Keep in mind that since this webcast....Cytodyn has treated a number of patients in this country which provide further data to strengthen the case for an EUA."
(4)
(0)