All the delays result basically from the FDA (exep
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Posted On: 01/20/2020 1:33:18 PM
Re: I_luv_cydy #15506
All the delays result basically from the FDA (exeption the 700mg stability data
here they droped the ball badly)
FDA deceided for 700 mg a couple of weeks ago. Now our BLA has to be adjusted.
If you take into account, that 150 people (or even more?)
had been writing and working on our BLA the last months, you get an idea about the scope and size. And we want to make sure everything is correct the first time, right? So better not to rush.
Nader said in December January, latest in February.
here they droped the ball badly)
FDA deceided for 700 mg a couple of weeks ago. Now our BLA has to be adjusted.
If you take into account, that 150 people (or even more?)
had been writing and working on our BLA the last months, you get an idea about the scope and size. And we want to make sure everything is correct the first time, right? So better not to rush.
Nader said in December January, latest in February.
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