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Re: chumppunk post# 38398

Friday, 03/08/2019 5:25:02 PM

Friday, March 08, 2019 5:25:02 PM

Post# of 233066
chump, trding - OK, got it

chump's

To skip this and request IV increase dosage would've thrown out their FDA submission into another category. Re-submission goals re-established, etc, etc. FDA would ask do you want approval SC or IV, make up your mind?


Makes sense, didn't consider any FDA complications when making up a mixed injection trial.

(btw, only debating the TNBC trial here)

trding's

I feel they will avoid iv if possible now. If needed maybe they will go to 3 injections,


yes, they could also do 1050 and 1400mg w/ SC on more frequent injections if needed.

As they can adjust the TNBC trial as they go, it should be OK then. I 'just' thought it would have been faster to start higher right away - but that is me probably being impatient (o8>
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