Additional interesting information from Philippine
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Posted On: 01/29/2021 5:58:58 PM
Additional interesting information from Philippine video
It has been noted that NP discussed early data release to the FDA, but he also mentioned the UK. At 51:30 he says:
“MHRA in UK already asked us to immediately send the results to them. The head of the FDA in the United States has requested to see the data as soon as it’s unblinded without waiting for top-line report. They are very eager to get this.”
My point is that in addition to the FDA, the UK also wants results ASAP. It sounds like they want it as soon as it is unblinded also, but NP did not exactly say that.
During the Q&A at the end, there was a discussion about how many doses were used for each patient. Dr. Agresti said they used 2 doses for each patient. Dr. Seethamraju said 4 of their eIND patients got 4 doses. I thought what he said at 46:25 was particularly interesting:
“In severe illness or in patients who are on home oxygen who are self-monitoring, we have actually sent nurses to administer the medication at home to prevent hospitalization and I think the greatest benefit with the monoclonal that we’re using will be when we administer before the onset or right at the onset of multi-organ dysfunction.”
Is this the first time that administering in a home has been mentioned?
Trivia - When NP was searching for a particular slide, you could see the name of the PowerPoint file at the top of the screen:
“CYDY Board Meeting 01-07-2021”
It has been noted that NP discussed early data release to the FDA, but he also mentioned the UK. At 51:30 he says:
“MHRA in UK already asked us to immediately send the results to them. The head of the FDA in the United States has requested to see the data as soon as it’s unblinded without waiting for top-line report. They are very eager to get this.”
My point is that in addition to the FDA, the UK also wants results ASAP. It sounds like they want it as soon as it is unblinded also, but NP did not exactly say that.
During the Q&A at the end, there was a discussion about how many doses were used for each patient. Dr. Agresti said they used 2 doses for each patient. Dr. Seethamraju said 4 of their eIND patients got 4 doses. I thought what he said at 46:25 was particularly interesting:
“In severe illness or in patients who are on home oxygen who are self-monitoring, we have actually sent nurses to administer the medication at home to prevent hospitalization and I think the greatest benefit with the monoclonal that we’re using will be when we administer before the onset or right at the onset of multi-organ dysfunction.”
Is this the first time that administering in a home has been mentioned?
Trivia - When NP was searching for a particular slide, you could see the name of the PowerPoint file at the top of the screen:
“CYDY Board Meeting 01-07-2021”
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