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I think they will definitely start in first half of this year, however this Phase 2 is make it or break it for Replicel.
This is an excerpt from the pdf:
- 160 participants
- 396 RCH-01 treatment group sites (vs. 16 in P1), with 244 placebo sites
- Designed to measure dosing and treatment frequency
- Primary commercial endpoint –efficacy at 52 weeks after final injection
efficacy measured as total density, hair thickness, cumulative hair and treatment response rate
- Secondary endpoints –52 weeks
local tolerance, systemic safety
Notice the bolded part: after 52 weeks (1 year) we will get the results for the Phase 2 data. That is when we will know how good RCH-01 really is. This is good. At least we won't be kept in the dark.
So expect results in H2 of 2016.
As for Shiseido I don't expect they will be forthcoming with news for the international scene. I think they will conduct their trials away from the public eye.
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