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Re: Zuess421 post# 44556

Saturday, 08/03/2019 12:14:14 PM

Saturday, August 03, 2019 12:14:14 PM

Post# of 233211
As I said, Nader told me, they have the safety data for 525mg. So that means obv. that they will not have the safety data for 700mg! (I asked him if they have, or will have till September the 700mg safety data as requested by the FDA)
The whole point is, that they dont have enough people on 700mg enrolled. FDA wants 100. So if the FDA will not accept 525mg, or will not accept safety data from less than 100 people (there are 75- 80??), we can not even file the BLA by end of the year.
Please correct me if Im wrong.
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