Wednesday, April 18, 2018 2:32:54 PM
and yes you are right ,for Ibalizumab they did Phase 1/2 study for SC and IM injections ,
it was completed 2016 in Taiwan.
" Current available UN-AUDITED data show tremendous antiviral activity , the results provided the possibility for IM as an alternative route of IV dose "
In 2017 they asked FDA for label extension from IV to IM for their MDR patients .
So they may have IM injection approve in some near future,
well, one never know with FDA of course , they may not approve base on the study done in Taiwan and not in USA , if approve it will be for the same MDR patients they treating with IV now,
If they want approval for different patients , they will need to do new study, and we know how long its take...
they still not Pro 140 patients as you said .
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