Found Brand New Article On Replicel And Their 2017 Outlook
- Thread starter Pavi
- Start date
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- 1,837
- In 2012, when we announced the safety and 6-month clinical efficacy data from our phase 1 study of RCH-01 (pattern baldness), we knew that in 2017 we would have 5-year safety data and both 12 and 24-month efficacy data which was all locked until the completion of the 5-year trial (all the trial participant data needed for this announcement has been collected and is now being prepared for third-party analysis)
RatherGoBlindThanSeeItGo
Established Member
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- 32
"We look forward to data from the Japanese RCH-01 (pattern baldness) study anticipated sometime in 2018 and continue to develop our own plans around the asset for markets outside Asia."
"We believe that Japan's unique regenerative medicine regulatory and industry environment provides a unique opportunity to rapidly advance this product in their country and are excited that RCH-01 (pattern baldness) has the potential to be launched in the Japanese market by Shiseido as soon as 2018."
Nothing we didn't already know, but it's nice to hear this again. Apparetly there's still some conflict between Replicel and Shiseido, but Shiseido is still on track nevertheless. I hope the 5-year safety data from Replicel and the clinical data from Shiseido will be positive, we'll have to wait a bit for the latter though... But at least the trial is underway and that's a positive thing!
"We believe that Japan's unique regenerative medicine regulatory and industry environment provides a unique opportunity to rapidly advance this product in their country and are excited that RCH-01 (pattern baldness) has the potential to be launched in the Japanese market by Shiseido as soon as 2018."
Nothing we didn't already know, but it's nice to hear this again. Apparetly there's still some conflict between Replicel and Shiseido, but Shiseido is still on track nevertheless. I hope the 5-year safety data from Replicel and the clinical data from Shiseido will be positive, we'll have to wait a bit for the latter though... But at least the trial is underway and that's a positive thing!
- Reaction score
- 374
They are basically making excuses for screwing up financially and telling us what an excellent job their japaneses rivals are doing, which throws themselves way behind in progress.
How does that help?
Has histogen started the mexico trial at all though?
How does that help?
Has histogen started the mexico trial at all though?
It was able to stop hairloss, apparently, but not regrow it like they had hoped.
As I recall, Aderans were bought out/started making wigs and they took their research to the grave.
- Reaction score
- 96
Wow that's sad
- Reaction score
- 540
risks, risks and risks MAYBE THAT'S WHY WE DON'T HAVE A CURE YET
These statements are only predictions and involve known and unknown risks which may cause actual results and the Company's plans and objectives to differ materially from those expressed in the forward-looking statements, including: the risk that the Company will not obtain CE mark clearance or other necessary regulatory approvals; the risk that there will be delays enrolling clinical trial participants; the risk that the Company will receive negative results from the Company's clinical trials; the effects of government regulation on the Company's business; risks associated with Shiseido obtaining approval for its clinical trial; risks associated with the Company obtaining approval for its clinical trial in Germany; risks associated with the Company obtaining all necessary regulatory approvals for its various programs in Canada, the USA and Germany; risks associated with the Company's ability to obtain and protect rights to its intellectual property; risks and uncertainties in connection with the outstanding issues alleged by Shiseido in connection with the License and Co-development Agreement; risks and uncertainties associated with the Company's ability to raise additional capital; and other factors beyond the Company's control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company's business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company's annual report on Form 20-F for the fiscal year ended December 31, 2015 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.
These statements are only predictions and involve known and unknown risks which may cause actual results and the Company's plans and objectives to differ materially from those expressed in the forward-looking statements, including: the risk that the Company will not obtain CE mark clearance or other necessary regulatory approvals; the risk that there will be delays enrolling clinical trial participants; the risk that the Company will receive negative results from the Company's clinical trials; the effects of government regulation on the Company's business; risks associated with Shiseido obtaining approval for its clinical trial; risks associated with the Company obtaining approval for its clinical trial in Germany; risks associated with the Company obtaining all necessary regulatory approvals for its various programs in Canada, the USA and Germany; risks associated with the Company's ability to obtain and protect rights to its intellectual property; risks and uncertainties in connection with the outstanding issues alleged by Shiseido in connection with the License and Co-development Agreement; risks and uncertainties associated with the Company's ability to raise additional capital; and other factors beyond the Company's control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company's business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company's annual report on Form 20-F for the fiscal year ended December 31, 2015 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.
Breyfogle
Established Member
- Reaction score
- 146
Awesome. We'll finally get the phase 1 safety data.
Replicel's phase 2 started in Germany exactly one year ago, and it's going to take about 2 more years.
Thank god they're still showing confidence in Japan releasing RCH1 as soon as 2018.
That will be lovely. I'll certainly be paying Japan a visit.
Replicel's phase 2 started in Germany exactly one year ago, and it's going to take about 2 more years.
Thank god they're still showing confidence in Japan releasing RCH1 as soon as 2018.
That will be lovely. I'll certainly be paying Japan a visit.
In the current state, Replicel would lose their royalty fee, but let me confirm me this to you a bit later.
Might had started in your dream, but unfortunately not in Germany.
Baldybald1
Established Member
- Reaction score
- 76
Why we care about replicel if shesiedo is going to release the treatment sooner !?
Because even if Shesiedo are succesful a contract dispute between them and Replicel could me years of legal fighting and ultimately nothing being released.
Because we need it outside of Japan.
Do you realize that you would have to stay 4 weeks on site to get the treatment? Not suitable for me...
- Reaction score
- 6,428
But they haven't even begun/may never conduct trials in Europe right? I'd rather pay the money in 2018 and spend 4 weeks in Japan than wait for a European release in 2020+
Living in Tokyo for a month would be very expensive, would be cheaper and easier to fly back. IIRC they want to do injections twice just to make sure that the scalp is completely covered and that no spots are missed by chance.
BruceMackenzie
Established Member
- Reaction score
- 120
2018 always seems so far away in my head. Then I realise it's only next year.
Ikkaku
Established Member
- Reaction score
- 339
Thank you!! It's really sad... I think their decisioners aren't smart....
They stopped hair loss and didn't go to market? Coulda cured me