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Re: z_smith post# 21797

Wednesday, 04/18/2018 2:32:54 PM

Wednesday, April 18, 2018 2:32:54 PM

Post# of 233720
Z_Smith - very good post , thank you.

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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