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Posted On: 01/10/2020 10:40:45 AM
Post# of 154292
P IV trial is also known as postmarketing trial, (confirmatory trial) after we get permission to sell Lero
What it means is that the FDA can do an Accelerated Approval Program and allow us to sell Leronlimab before It could be done with a typical approval program.
We then will continue monitoring for safety (pharmacovigilance), where I think we would not have any problems and ongoing support of Leronlimab in case something comes up.
This is (or would be) good news as basically means that FDA will give us a longer leash and let us sell more quickly Lero with us monitoring the results (and gathering more statistical data) once the drug is out there !!!
What it means is that the FDA can do an Accelerated Approval Program and allow us to sell Leronlimab before It could be done with a typical approval program.
We then will continue monitoring for safety (pharmacovigilance), where I think we would not have any problems and ongoing support of Leronlimab in case something comes up.
This is (or would be) good news as basically means that FDA will give us a longer leash and let us sell more quickly Lero with us monitoring the results (and gathering more statistical data) once the drug is out there !!!
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