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Posted On: 05/07/2019 3:57:27 PM
Post# of 149510
New interview at about 1:40 NP said , if FDA will agree with our 525 dose we are ready with submission of second part of our BLA !!!!!!
Little later he also said they almost read to submit pivotal mono .
So all the delay was FDA observation I believe about 525 mg responses ..
Little later he also said they almost read to submit pivotal mono .
So all the delay was FDA observation I believe about 525 mg responses ..
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