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  1. #21
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    Quote Originally Posted by hellouser View Post
    That page doesnt say anything about Phase IIa or IIb as Desmond mentioned. Neither does the pipeline page:

    http://www.replicel.com/product-pipe...-regeneration/

    They only mention Phase II as a single trial.
    but at thebeginning of that article they mention their results from a phase 1/2A so it makes sense to assume all they have left is two B

    Quote Originally Posted by FearTheLoss View Post
    scroll all the way to the bottom of the page

    http://www.replicel.com/hair-regener...air-loss/faqs/
    yeah that's the chart I was referring to earlier... how can we assume at the end of the arrow comes commercialization, instead of something else e.g. phase 3 in NA

  2. #22
    Senior Member Desmond84's Avatar
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    Yeah unfortunately Phase 2b is 2 years and then you need to at least give it 6 months for data analysis and another 3-4 months for an Asian country to approve the product.

    This makes Asian release somewhere between November 2016 and January 2017!

    Sad but true

    P.S. Don't forget that they may never reach the market if they can't out-perform finasteride! If only they knew how many of us would pay anything to use their therapy instead!

  3. #23
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    Quote Originally Posted by Desmond84 View Post
    Yeah unfortunately Phase 2b is 2 years and then you need to at least give it 6 months for data analysis and another 3-4 months for an Asian country to approve the product.

    This makes Asian release somewhere between November 2016 and January 2017!

    Sad but true

    P.S. Don't forget that they may never reach the market if they can't out-perform finasteride! If only they knew how many of us would pay anything to use their therapy instead!
    In a previous post i was thinking about 2018 (with a year to analyze the results) but in their investor relation (which is being made this year they still pointing at 2015 i don't know how they possible make it.

    What i don't like: i was thinking that phase IIb was about multiple treatments to find the low useful dosage, so i was expected 1 injection at months or every 3 months o even 6 months if the effect would been extended so far.

    Instead... 1 injection the first day, another at day 91 and stop. I really don't know nothing about pharmaceutical trials and its protocols but seems to me completely illogical.

    Here are the details
    Primary endpoints: Efficacy (density, hair thickness, cumulative hair),
    treatment response rate
    Secondary endpoints: Local tolerance, systemic safety

    120 male patients:
    – 3 injection sites, 1 shaved site per patient as reference
    – Treatment group (96 patients)
    • 48 treated with single injections (3 different doses)
    • 48 treated with repeat injections at day 1 and 91 (3 different doses)

    – Placebo group (24 patients)
    • 12 treated with single injection (carrier vehicle only)
    • 12 treated with repeat placebo at day 1 and 91

    – 288 treated data sites (Compared to 16 in Phase I)

    – 72 placebo data sites

    – Primary Institution: Charité-Universitätsmedizin, Berlin

    Proposed Phase II Design
    RCH-01Phase II Status
    Advisory meetings with EU Regulators (Paul-Ehrlich-Institut):
    • Product manufacturing presentation (Nov 2, 2012) 
    – Minimal changes - must add certain process validations protocols
    • Clinical design presentation (Feb 2013) 
    – Feedback on proposed clinical treatment protocol
    • Clinical trial application (Mid-2013)
    • Ethics Review Board - Charité-Universitätsmedizin, Berlin (Mid-2013)
    • Phase II trial initiation Mid-2013

  4. #24
    Senior Member Desmond84's Avatar
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    Quote Originally Posted by mari0s View Post
    In a previous post i was thinking about 2018 (with a year to analyze the results) but in their investor relation (which is being made this year they still pointing at 2015 i don't know how they possible make it.

    What i don't like: i was thinking that phase IIb was about multiple treatments to find the low useful dosage, so i was expected 1 injection at months or every 3 months o even 6 months if the effect would been extended so far.

    Instead... 1 injection the first day, another at day 91 and stop. I really don't know nothing about pharmaceutical trials and its protocols but seems to me completely illogical.

    Here are the details
    Yeah...it seems a bit rushed BUT at least there is a second injection timepoint which is great...we'll see if it is compoundable. In 3 months, you can impact follicles that may have been in Telogen phase during the previous session.

    At the end of the day, if it was compoundable, they might add a third session in their Phase 3 trials! It has happened before with other therapies.

    2015 seems unlikely though unless their target asian country is somewhere with VERY loose regulatory approval process! Thailand, Philippines or Indonesia could be where they are planning to release it first.

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