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Posted On: 12/27/2020 2:11:56 PM
Post# of 148899
Your right... I previously posted to use interim approval as additional evidence to a CD-10 Philippines EUA approval process that could also be used to acquire the quicker CD-12 EUA when we unblind on January 12th. That 50% interim look by the DSMC would of been already calculated and available right away is my assumption.
The reason we don’t need a EUA here first 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
While article:
https://insiderfinancial.com/rise-of-the-covi...en/180780/
The reason we don’t need a EUA here first 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
While article:
https://insiderfinancial.com/rise-of-the-covi...en/180780/
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