Does anyone have an idea when it will be submitted
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Posted On: 07/05/2022 12:38:48 PM
Re: HouseofCards #125954
Does anyone have an idea when it will be submitted ? I know we have a type C meeting which should be in a month or so. They haven’t really said much.
My guess is still the same at the start of the year. We file the BLA Q4 of this year. We have the data that needs to be fixed/reformatted. It’s just a matter of time until we get the go ahead to file again. It appears the FDA is working very closely with us on this issue.
My guess is still the same at the start of the year. We file the BLA Q4 of this year. We have the data that needs to be fixed/reformatted. It’s just a matter of time until we get the go ahead to file again. It appears the FDA is working very closely with us on this issue.
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