After Chuckles post, I did some research on the pa
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Posted On: 10/19/2020 2:21:19 AM
Re: chuckles759 #61830
After Chuckles post, I did some research on the path to approval of trial data. Chuckles said the path for HIV BLA was through CBER, the Center for Biologics Evaluation and Research, a division of the FDA. That is not right. Monoclonal Antibodies are evaluated by CDER, the Center for Drug Evaluation and Research.
Back on May 25th, Sunny3999 posted this -
FDA WARP Speed operation for Covid -19 therapeutics responsibility:
Dr. Janet Woodcock; @DrWoodcockFDA; 22. Mai
Quote: I've been asked to oversee the therapeutics development for the US government for #COVID19. The goal is to do everything the US government possibly can do to accelerate development of treatments and preventives while we wait for a vaccine to be developed.
Quote: I'll do my best to try and advance therapeutics. It's quite a challenge but I’ll try to advance efforts that will be the most fruitful and most expedient in getting effective therapies into the hands of doctors and patients.
https://twitter.com/DrWoodcockFDA/status/1263933388085485568
Dr. Stephan Hahn FDA order:
https://twitter.com/SteveFDA/status/1263909609930178560
Read More: https://investorshangout.com/post/view?id=577...z6bIJ2HaV8
I think it was someone on the YMB that said that Janet Woodcock listened in on Dr. Seethamraju's recent presentation on the result of CD10 trials. It seem to me that she would be the one to watch for CDER or OWS movement on advancing Leronlimab's fate.
She knows about Leronlimab, she knows about its trials and she is in charge of evaluating and accelerating useful Covid-19 therapeutics. She is the one who would have decided Leronlimab's fate had it gone through ACTIV trial. CDER is the receiver of the results of those trials and takes the next steps for drug evaluation and an eventual BLA.
Let's hope the unblinded results of the Interim Review land on her desk or at least her office. We couldn't hope for more, in my opinion.
This interview she did just 4 days ago is very informative for all of us here.
https://www.cnbc.com/video/2020/10/15/healthy...dcock.html
Enjoy!
Back on May 25th, Sunny3999 posted this -
FDA WARP Speed operation for Covid -19 therapeutics responsibility:
Dr. Janet Woodcock; @DrWoodcockFDA; 22. Mai
Quote: I've been asked to oversee the therapeutics development for the US government for #COVID19. The goal is to do everything the US government possibly can do to accelerate development of treatments and preventives while we wait for a vaccine to be developed.
Quote: I'll do my best to try and advance therapeutics. It's quite a challenge but I’ll try to advance efforts that will be the most fruitful and most expedient in getting effective therapies into the hands of doctors and patients.
https://twitter.com/DrWoodcockFDA/status/1263933388085485568
Dr. Stephan Hahn FDA order:
https://twitter.com/SteveFDA/status/1263909609930178560
Read More: https://investorshangout.com/post/view?id=577...z6bIJ2HaV8
I think it was someone on the YMB that said that Janet Woodcock listened in on Dr. Seethamraju's recent presentation on the result of CD10 trials. It seem to me that she would be the one to watch for CDER or OWS movement on advancing Leronlimab's fate.
She knows about Leronlimab, she knows about its trials and she is in charge of evaluating and accelerating useful Covid-19 therapeutics. She is the one who would have decided Leronlimab's fate had it gone through ACTIV trial. CDER is the receiver of the results of those trials and takes the next steps for drug evaluation and an eventual BLA.
Let's hope the unblinded results of the Interim Review land on her desk or at least her office. We couldn't hope for more, in my opinion.
This interview she did just 4 days ago is very informative for all of us here.
https://www.cnbc.com/video/2020/10/15/healthy...dcock.html
Enjoy!
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