a) they do not even have to complete phase 2
b) it was said 3000 - 5000 dollar per procedure
c) your doubts in term of space and number of customers are ridiculous
Where did you hear it'd be between 3 and 5k?
01-26-2015 06:13 PM
sdsurfin
"Thank you for your email and interest in the potential product we are developing and testing for the treatment of pattern baldness. We are as anxious as you to see this through the required development/testing stages and approvals to get the product available on the market. We did have, as you may know, some manufacturing issues to resolve which slowed down our progression to the phase 2 trial considerably. This has now been resolved and we are ready, once again, to go full speed ahead with clinical development and testing. We are also pleased that Shiseido now has their manufacturing facility ready and has validated their ability to manufacture the product meaning they anticipate also being able to proceed shortly with their own trial in Japan concurrent with ours. While 2014 was a year of re-tooling, 2015 will be all about moving forward as quickly as possible on both clinical trials for RCH-01 for pattern baldness in addition to our other clinical trials.
As for the phase 1 trial results, it is important to understand that the purpose of a phase 1 trial is to prove that your product is safe. We injected a very high dosage of RCH-01 into each patient and no adverse events were recorded. Now that we have proven the product is safe, the phase 2 trial is designed to determine the optimum dose and frequency. Our phase 2 trial will include approx. 160 patients. We will be injecting approx. 396 sites with RCH-01 and approx. 244 with placebo. This data will give us a clear indication of efficacy.
In our phase 1 trial only 18 patients were injected with a very high dose of RCH-01. The primary objective of our phase 1 study was to assess the local (at treatment sites) safety profile of injections of autologous dermal sheath cup cells (DSCC) at 6 months post-injection compared to control. Secondary objectives were to assess systemic (overall) safety, local safety, and efficacy at 24 months post-injection. The safety data collected from study participants 12-months after receipt of injections of verum and control revealed that the RepliCel™ treatment was very safe and well-tolerated. This data, coupled with positive increases in hair growth efficacy measured at 6-months post-injection, provided support for the Company to move forward with the development of its Phase 2 dosing trial. Safety only will continue to be monitored on these patients for a total of 5 years post injection.
We remain extremely optimistic about the potential of RCH-01 as a treatment for pattern baldness and expect to start our phase 2 trial this year."
01-26-2015 08:09 PM
efedrez
Thank you for shearing! I'm feeling very optimistic about replicel... Can't wait for phase 2 to begin
