Excellent Post. They seem to be looking seriou
Post# of 154127
(Total Views: 513)
Posted On: 09/13/2019 7:30:51 PM
Excellent Post.
NP said "we need to give them 700 mg dose, by the end of October, we will have what they ask for."
They have 830 patients enrolled now, 124@700 195@525 from June Poster. In march they had 740 patients enrolled, PR, so 90 less patients, 45 for each random arm would give 80@70 in march, also on feb 1st they had 45@700 enrolled. So with all those numbers I can't see how they have just 50 enrolled at the middle of may @700, four months later.. (middle of may to end of October is 24 weeks)
If the fda had accepted 525mg they would have been ready to submit by the end of September. But with the additional 700mg requirement it will take them an extra time to finish all the work required to include 700mg in the write-up of part 2 of the BLA, i.e. I believe the safety data for the 700mg is done, but the write-up of everything that must be included for 700mg isn't.
In any case, part 3 is the hold up, the stability data for 700mg, so it isn't critical either way. Just I'm expecting part 2 possibly submitted by the end of October. Not that the data is done by the end of October and then the write-up for that can begin, taking a few more weeks. We will see.
Quote:
They seem to be looking seriously at the 700 mg dose and need 24 weeks’ safety
NP said "we need to give them 700 mg dose, by the end of October, we will have what they ask for."
They have 830 patients enrolled now, 124@700 195@525 from June Poster. In march they had 740 patients enrolled, PR, so 90 less patients, 45 for each random arm would give 80@70 in march, also on feb 1st they had 45@700 enrolled. So with all those numbers I can't see how they have just 50 enrolled at the middle of may @700, four months later.. (middle of may to end of October is 24 weeks)
If the fda had accepted 525mg they would have been ready to submit by the end of September. But with the additional 700mg requirement it will take them an extra time to finish all the work required to include 700mg in the write-up of part 2 of the BLA, i.e. I believe the safety data for the 700mg is done, but the write-up of everything that must be included for 700mg isn't.
In any case, part 3 is the hold up, the stability data for 700mg, so it isn't critical either way. Just I'm expecting part 2 possibly submitted by the end of October. Not that the data is done by the end of October and then the write-up for that can begin, taking a few more weeks. We will see.
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