The reason we don’t need a EUA here first in the
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Posted On: 12/28/2020 7:06:38 PM
The reason we don’t need a EUA here first in the USA is because we have a local pharmaceutical company or agent in the Philippines submitting our information for an EUA for CD-10 and when unblinded CD-12. Below is a comparison of Humanigen to CYDY by CNN captured in a insiderfinacial article at the bottom of the post.
CNN covered the news conference, and it’s very clear that CytoDyn meets the parameters laid out in the executive order. There are clear benefits of leronlimab laid out in the phase 2 mild to moderate CD-10 study. The benefits have to outweigh the risks of taking it and no treatment is approved for severe to critical covid that works. Many might forget that in the CD-10 trial leronlimab reduced the incidence of SAE’s by 60% over the control group. An important highlight is a key nuance that the CEO of Humanigen overlooked. The filing of an EUA “shall be done by the industry or government concerned.” Humanigen had not made any mention of an agent in the Philippines which means that Humanigen would need an EUA in the USA but CytoDyn was skillful in securing a local sponsor and that perhaps accounts for the disparity between the two CEO’s
Which means to me; that we don’t need a EUA in the USA first. This is why we have an agent in the Philippines and can receive a EUA from the Philippines without a EUA in the USA.
The question is have we filed? That is what we don’t know but 21 days is long and we could of filed as soon as the 14th of December by our agents process and I am not sure that is reportable if they are our acting agent acting in our place. Could we have already filed? You tell me...
Dec 14th + 21 days = Jan 4th
Is this the date for EUA before we unblind on the 12th of January and submit to our own FDA any day soon there after?
Read More: https://investorshangout.com/post/view?id=600...z6hxyH2MpO
CNN covered the news conference, and it’s very clear that CytoDyn meets the parameters laid out in the executive order. There are clear benefits of leronlimab laid out in the phase 2 mild to moderate CD-10 study. The benefits have to outweigh the risks of taking it and no treatment is approved for severe to critical covid that works. Many might forget that in the CD-10 trial leronlimab reduced the incidence of SAE’s by 60% over the control group. An important highlight is a key nuance that the CEO of Humanigen overlooked. The filing of an EUA “shall be done by the industry or government concerned.” Humanigen had not made any mention of an agent in the Philippines which means that Humanigen would need an EUA in the USA but CytoDyn was skillful in securing a local sponsor and that perhaps accounts for the disparity between the two CEO’s
Which means to me; that we don’t need a EUA in the USA first. This is why we have an agent in the Philippines and can receive a EUA from the Philippines without a EUA in the USA.
The question is have we filed? That is what we don’t know but 21 days is long and we could of filed as soon as the 14th of December by our agents process and I am not sure that is reportable if they are our acting agent acting in our place. Could we have already filed? You tell me...
Dec 14th + 21 days = Jan 4th
Is this the date for EUA before we unblind on the 12th of January and submit to our own FDA any day soon there after?
Read More: https://investorshangout.com/post/view?id=600...z6hxyH2MpO
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