You probably think regarding to this:
The TS001-2009 study team will be performing a thorough review of the collected study data throughout the months of March and April 2012.* Once complete, the treatment groups will be revealed (‘un-blinded’) to the data analysis team and the data will be analyzed. RepliCel remains on schedule to release the initial review of efficacy results in April 2012.
So, they should release the data in april, not march.
Further:
Subject efficacy at 6-months post injection is the first step in measuring a treatment response.* All subjects will continue to participate in the post injection follow-up period of the study until August 2013 and a review of final safety and efficacy results will commence before the end of 2013.** The continued follow-up period is a key component of the study to confirm treatment safety profile and response trends at 6, 12 and 24 months.
The initial data from RepliCel’s 6-month subject follow-up will be used in the Company’s Investigational Medical Product Dossier (IMPD), which is presently being developed for a Phase IIb dose-ranging clinical trial of 100 patients that is expected to commence in fall 2012.* The protocol will be submitted to the EMEA, FDA and Health Canada for review.* A final decision on the location of the trial is pending.
So, basically IF IT WORKS, last tests will be conducted before the end of 2013, probably meaning it could go to market in 2015.
That is IF IT WORKS as well as they presume it does.
We'll see the first results in april then.
The TS001-2009 study team will be performing a thorough review of the collected study data throughout the months of March and April 2012.* Once complete, the treatment groups will be revealed (‘un-blinded’) to the data analysis team and the data will be analyzed. RepliCel remains on schedule to release the initial review of efficacy results in April 2012.
So, they should release the data in april, not march.
Further:
Subject efficacy at 6-months post injection is the first step in measuring a treatment response.* All subjects will continue to participate in the post injection follow-up period of the study until August 2013 and a review of final safety and efficacy results will commence before the end of 2013.** The continued follow-up period is a key component of the study to confirm treatment safety profile and response trends at 6, 12 and 24 months.
The initial data from RepliCel’s 6-month subject follow-up will be used in the Company’s Investigational Medical Product Dossier (IMPD), which is presently being developed for a Phase IIb dose-ranging clinical trial of 100 patients that is expected to commence in fall 2012.* The protocol will be submitted to the EMEA, FDA and Health Canada for review.* A final decision on the location of the trial is pending.
So, basically IF IT WORKS, last tests will be conducted before the end of 2013, probably meaning it could go to market in 2015.
That is IF IT WORKS as well as they presume it does.
We'll see the first results in april then.
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