Here from YMB. It’s pretty clear.... • Mana
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Posted On: 03/18/2021 1:53:19 PM
Re: craigakess #83516
Here from YMB. It’s pretty clear....
• Management will update stockholders on the Company’s RECENT COVID-19 related FILINGS FOR CONDITIONAL EUA with the FDA in U.S., Interim Order in Canada, AND accelerated rolling review in U.K.
• As well as POTENTIAL similar FILINGS in Brazil and the Philippines.
• Management will also provide updates on its active trials in COVID-19, NASH and Cancer, along with EXPECTED timelines for BLA SUBMISSIONS for HIV in U.S., Canada and U.K.
Explains the story well with no need for interpretation and this rolls up into the PR heading (to be clear, I would not have chosen the title language either). NP and team will not confound the content of the PR and there will be SEVERE actions by FDA if they did… Further, since they HAVE filed an application with US FDA for conditional EUA, the outcome of this submission will guide CYDYs next steps with regards to filing in Brazil and Philippines and if it is warranted. I have said all along, the FDA will “guide” CYDY on what they “should” do and it will be implied they follow the guidance since they will be seeking an approval for HIV BLA in the near future. It’s not necessarily a threat by FDA, it’s best practice guidance that CYDY SHOULD FOLLOW and since CYDY was put in the “Penalty Box” in JUL2020 due to a poor BLA submission, CYDY has been listening more that acting and gaining redemption. Mahboob (and other team members who speak the FDAs language) I’m sure has projected the FDAs internal stance to the CYDY team and they (IMHO) are being cautious based upon the frequency of activities that have/have not been announced.
Folks need to remember an EUA submission is a multi-step process. There will [likely] be a pre-EUA meeting, an application submitted by CYDY, review of the application by FDA with potential questions, setting of the scope of the EUA (often a back and forth), reviewing and approving supporting documentation to include IFUs for health care providers, labeling, etc.. If anything is in the works for any conditional approval, it will be suppressed at all costs until FDA is ready for CYDY to announce an outcome.
Looking forward to the update and appreciate the deep thinkers on this board
• Management will update stockholders on the Company’s RECENT COVID-19 related FILINGS FOR CONDITIONAL EUA with the FDA in U.S., Interim Order in Canada, AND accelerated rolling review in U.K.
• As well as POTENTIAL similar FILINGS in Brazil and the Philippines.
• Management will also provide updates on its active trials in COVID-19, NASH and Cancer, along with EXPECTED timelines for BLA SUBMISSIONS for HIV in U.S., Canada and U.K.
Explains the story well with no need for interpretation and this rolls up into the PR heading (to be clear, I would not have chosen the title language either). NP and team will not confound the content of the PR and there will be SEVERE actions by FDA if they did… Further, since they HAVE filed an application with US FDA for conditional EUA, the outcome of this submission will guide CYDYs next steps with regards to filing in Brazil and Philippines and if it is warranted. I have said all along, the FDA will “guide” CYDY on what they “should” do and it will be implied they follow the guidance since they will be seeking an approval for HIV BLA in the near future. It’s not necessarily a threat by FDA, it’s best practice guidance that CYDY SHOULD FOLLOW and since CYDY was put in the “Penalty Box” in JUL2020 due to a poor BLA submission, CYDY has been listening more that acting and gaining redemption. Mahboob (and other team members who speak the FDAs language) I’m sure has projected the FDAs internal stance to the CYDY team and they (IMHO) are being cautious based upon the frequency of activities that have/have not been announced.
Folks need to remember an EUA submission is a multi-step process. There will [likely] be a pre-EUA meeting, an application submitted by CYDY, review of the application by FDA with potential questions, setting of the scope of the EUA (often a back and forth), reviewing and approving supporting documentation to include IFUs for health care providers, labeling, etc.. If anything is in the works for any conditional approval, it will be suppressed at all costs until FDA is ready for CYDY to announce an outcome.
Looking forward to the update and appreciate the deep thinkers on this board
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