That's just how it is... the guidelines are clear.
Post# of 148181
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Posted On: 07/15/2020 12:27:53 PM
Re: Goosebumps #43092
That's just how it is... the guidelines are clear.
Rolling review simply means that the individual parts can be submitted separately and already be looked at.
Since CYDY submitted clinical and manufacturing part together, the advantage of that designation (i.e. getting more feedback on the submited parts) has been somewhat negated. CMC part which had been submitted in March 2019 already seems to have been reviewed already and it was okay.
So, they will do a Type A meeting (30 days), wait for the minutes (30 days), do the work in the meantime and thereafter (another 30 days perhaps) = 5 months -> re-filing = 2 months -> acceptance, priority review = 6 months.
Altogether we are looking at June/July 2021 for combo approval, a bit earlier if they take less than 6 months to review and less than 2 months to accept refiled BLA.
Rolling review simply means that the individual parts can be submitted separately and already be looked at.
Since CYDY submitted clinical and manufacturing part together, the advantage of that designation (i.e. getting more feedback on the submited parts) has been somewhat negated. CMC part which had been submitted in March 2019 already seems to have been reviewed already and it was okay.
So, they will do a Type A meeting (30 days), wait for the minutes (30 days), do the work in the meantime and thereafter (another 30 days perhaps) = 5 months -> re-filing = 2 months -> acceptance, priority review = 6 months.
Altogether we are looking at June/July 2021 for combo approval, a bit earlier if they take less than 6 months to review and less than 2 months to accept refiled BLA.
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