Flash, If BTD applications are a component of o
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Posted On: 02/20/2022 10:58:26 AM
Flash,
If BTD applications are a component of our current timing situation, I’d expect the middle of March to be the earliest we will hear news (at least concerning BTDs). This would be 60 days after mid-January, which to my mind is the earliest a BTD application for NASH could have been completed - although because of the holidays a submission could easily have taken longer.
If all of the components of our timing situation are linked (ie partnership or buyout, or even HIV BLA submission), this could take even longer.
Question: is a granted or denied BTD application (the FDA decision) considered a material event. In that case, they may have to tell us this news a few days after it occurs.
Fervent patience to all longs,
chazzle
If BTD applications are a component of our current timing situation, I’d expect the middle of March to be the earliest we will hear news (at least concerning BTDs). This would be 60 days after mid-January, which to my mind is the earliest a BTD application for NASH could have been completed - although because of the holidays a submission could easily have taken longer.
If all of the components of our timing situation are linked (ie partnership or buyout, or even HIV BLA submission), this could take even longer.
Question: is a granted or denied BTD application (the FDA decision) considered a material event. In that case, they may have to tell us this news a few days after it occurs.
Fervent patience to all longs,
chazzle
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