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Posted On: 03/01/2021 12:48:46 PM
Post# of 153964
Re: reallypeople? #80317
Reallypeople - to answe your question
I don’t expect full approval for the COVID-19 indication in the next few weeks because Cytodyn will not have filed a full BLA in that timeframe.
EUA is a special type of approval that requires much less information and it is reasonable to expect this level of approval if the results are as good as some people are speculating for a very defined use.
I personally expect full approval for HIV Combo once they get the filing straightened out so that the FDA accepts the submission and completes their review . The efficacy results were excellent. They have a good contract manufacturer for the cmc section and the third section has been filed for a long time now.
All IMO
All IMO
I don’t expect full approval for the COVID-19 indication in the next few weeks because Cytodyn will not have filed a full BLA in that timeframe.
EUA is a special type of approval that requires much less information and it is reasonable to expect this level of approval if the results are as good as some people are speculating for a very defined use.
I personally expect full approval for HIV Combo once they get the filing straightened out so that the FDA accepts the submission and completes their review . The efficacy results were excellent. They have a good contract manufacturer for the cmc section and the third section has been filed for a long time now.
All IMO
All IMO
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