$RLFTF Relief's website updated: "How long will i
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Posted On: 12/30/2020 1:05:52 PM
Re: CaptnAmerca #288
$RLFTF Relief's website updated: "How long will it take the FDA to approve RLF-100™ after top-line data are available?
Assuming that the top-line are positive, the FDA could at that time consider granting EUA, which would permit the drug to be launched in Q1 2021.
A New Drug Application (NDA) submission requesting marketing approval would be filed based on positive top-line results. Full NDA approval could be granted to RLF-100 for the US market by Q3 2021.
The FDA granted RLF-100™ fast track designation, which, among other things, makes RLF-100™ eligible for Priority Review if relevant criteria are met.
Priority Review designation means the FDA’s goal is to take action on an application within 6 months compared to 10 months under standard review.
It would be reasonable to expect Priority Review for applications filed under the Coronavirus Treatment Acceleration Program (CTAP). RLF-100TM is part of this program, which was promulgated by the FDA earlier this year in express response to the emergence of the COVID-19 pandemic."
- Alexandre
Assuming that the top-line are positive, the FDA could at that time consider granting EUA, which would permit the drug to be launched in Q1 2021.
A New Drug Application (NDA) submission requesting marketing approval would be filed based on positive top-line results. Full NDA approval could be granted to RLF-100 for the US market by Q3 2021.
The FDA granted RLF-100™ fast track designation, which, among other things, makes RLF-100™ eligible for Priority Review if relevant criteria are met.
Priority Review designation means the FDA’s goal is to take action on an application within 6 months compared to 10 months under standard review.
It would be reasonable to expect Priority Review for applications filed under the Coronavirus Treatment Acceleration Program (CTAP). RLF-100TM is part of this program, which was promulgated by the FDA earlier this year in express response to the emergence of the COVID-19 pandemic."
- Alexandre
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