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Posted On: 05/08/2021 11:49:54 PM
Post# of 154604
Someone posted this on the Facebook CytoDyn Shareholders Community yesterday about the EMA looking at therapeutics. The link below is for the EMA article and a list of 57 therapeutics that have received EMA advice. Note that when the poster sent the email to Dr. Kelly, he promptly replied. I think we have some posters from the EU - they may be familiar with this initiative. In any event, perhaps the EMA will work proactively with CYDY. What a change that would be!
https://www.ema.europa.eu/en/human-regulatory...fTwqIZFHP0
FYI, I have Emailed to Dr. Nader & Dr. Scott Kelly to alert them on this. Hopefully they will respond and more importantly, act on it or get their European agency to do so ASAP.
Further to my earlier post on European Medicines Agency (EMA) interacting with developers of potential COVID-19 treatments to enable promising medicines to reach patients in the European Union (EU), where the Strategy includes clear actions and targets, including authorising three new therapeutics to treat COVID-19 by October 2021 and possibly two more by end of the year.
A list of 57 drugs are already listed with EMA for under consideration (see below EMA website article), and I'm frankly shocked LERONLIMAB is not one of them!
From this list, only 36 are clinical, the rest are still in Phase 1 development and thus will not qualify for a 2021 approval/use.
Of said 36 clinical drugs, only 13 completed Phase 3 trials. Of those 13, 5 showed NO benefit.
That leaves 8 drugs, 7 of which seems to show statistically significant results and 1 is pending on a Phase 3 result. 2 of the 7 drugs have EUA (Remdesivir and Baricitinib), and Remdesivir already has an EMA.
Got am immediate Email reply from the cool baritone voiced Dr. Scott Kelly : -
Excellent, Daryl. Thank you so much!
Best,
Scott
Scott A. Kelly, M.D.
https://www.ema.europa.eu/en/human-regulatory...fTwqIZFHP0
FYI, I have Emailed to Dr. Nader & Dr. Scott Kelly to alert them on this. Hopefully they will respond and more importantly, act on it or get their European agency to do so ASAP.
Further to my earlier post on European Medicines Agency (EMA) interacting with developers of potential COVID-19 treatments to enable promising medicines to reach patients in the European Union (EU), where the Strategy includes clear actions and targets, including authorising three new therapeutics to treat COVID-19 by October 2021 and possibly two more by end of the year.
A list of 57 drugs are already listed with EMA for under consideration (see below EMA website article), and I'm frankly shocked LERONLIMAB is not one of them!
From this list, only 36 are clinical, the rest are still in Phase 1 development and thus will not qualify for a 2021 approval/use.
Of said 36 clinical drugs, only 13 completed Phase 3 trials. Of those 13, 5 showed NO benefit.
That leaves 8 drugs, 7 of which seems to show statistically significant results and 1 is pending on a Phase 3 result. 2 of the 7 drugs have EUA (Remdesivir and Baricitinib), and Remdesivir already has an EMA.
Got am immediate Email reply from the cool baritone voiced Dr. Scott Kelly : -
Excellent, Daryl. Thank you so much!
Best,
Scott
Scott A. Kelly, M.D.
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