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Posted On: 09/09/2019 3:38:34 PM
Post# of 149265
Sjacobs, Yup, quite possible. If FDA does not know which one is better 525mg Vs 700mg and there is a way to find out (ROT), they might just say: "OK CYDY we will approve but please measure and tell us which one is better based on occupancy vs dosis statistics. We will approve whichever is best."
This will take some time depending on how broad they want the statistics to be (n for a good standard deviation and mean calculation).
This is being victim of your own success, but I really don't care. We need an approved BLA. Period.
This is all pure speculation of my part in the same line of your thoughts.
This will take some time depending on how broad they want the statistics to be (n for a good standard deviation and mean calculation).
This is being victim of your own success, but I really don't care. We need an approved BLA. Period.
This is all pure speculation of my part in the same line of your thoughts.
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