$RLFTF (FDA AMA Related) DD by K. : From the Webi
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Posted On: 03/17/2021 8:47:21 PM
$RLFTF (FDA AMA Related) DD by K. : From the Webinar, the FDA wants to authorize more therapeutics. They understand science and want to be guided by science.
Highlights:
Only 5% of ALL COVID studies worldwide are RCT, and are well powered enough to generate any meaningful data for the FDA to work with.
FDA wants to approve more therapeutics as soon as those therapeutics submit their data, so we can have more drugs to beat covid.
The FDA clearly understands that we don't have enough therapeutics to fight severe Covid.
The FDA in co operation with the NIH has tested the mabs against the UK variant of covid and so far, the mabs seem to work for this strain.
There is a different covid strain that is prevalent in Nevada and california and bam is not working for this strain.
There are other covid strains that the FDA is concerned about. The FDA/CDC are working together to test the approved drugs against these strains.
I felt the webinar was biased to early / mild covid symptoms as the moderator was an outpatient physician.
Very little was covered on inpatient/critical covid pts, which is the most concerned.
They mentioned steroids and Remdesivir.
Off course they can'tention Aviptadil by name or insinuate anything about the drugwithiut results (good/bad).
The FDA really wants therapeutics that would be easy to administer at home.
They also see the void of therapeutics for critical pts.
My take from today's meeting is that if your data is solid, an EUA is imminent. They are however very gangho about the study set up inorder to generate meaningful data.
I am
Highlights:
Only 5% of ALL COVID studies worldwide are RCT, and are well powered enough to generate any meaningful data for the FDA to work with.
FDA wants to approve more therapeutics as soon as those therapeutics submit their data, so we can have more drugs to beat covid.
The FDA clearly understands that we don't have enough therapeutics to fight severe Covid.
The FDA in co operation with the NIH has tested the mabs against the UK variant of covid and so far, the mabs seem to work for this strain.
There is a different covid strain that is prevalent in Nevada and california and bam is not working for this strain.
There are other covid strains that the FDA is concerned about. The FDA/CDC are working together to test the approved drugs against these strains.
I felt the webinar was biased to early / mild covid symptoms as the moderator was an outpatient physician.
Very little was covered on inpatient/critical covid pts, which is the most concerned.
They mentioned steroids and Remdesivir.
Off course they can'tention Aviptadil by name or insinuate anything about the drugwithiut results (good/bad).
The FDA really wants therapeutics that would be easy to administer at home.
They also see the void of therapeutics for critical pts.
My take from today's meeting is that if your data is solid, an EUA is imminent. They are however very gangho about the study set up inorder to generate meaningful data.
I am
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