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Posted On: 11/26/2019 7:38:17 AM
Post# of 149246
Looks that you and Lorbas are right and dose will be given to us in December , but that mean that they giving all the results from clinical part now to FDA.
Maybe official report of part 2 of BLA they will submit in December , I dont know , but all the results from it they gave/giving now.
FDA must evaluate those results before making decision as for a dose , 525 or 700 mg.
But I am not sure why licensing will depend of a dose , but I don't really know..maybe as you said to be sure they dont want any more stuff , who knows ..
Anyway we are close...
Maybe official report of part 2 of BLA they will submit in December , I dont know , but all the results from it they gave/giving now.
FDA must evaluate those results before making decision as for a dose , 525 or 700 mg.
But I am not sure why licensing will depend of a dose , but I don't really know..maybe as you said to be sure they dont want any more stuff , who knows ..
Anyway we are close...
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