Has anyone noticed that Replicel's product pipeline webpage asserts that their hair product is on trajectory for a 2015 release? Is that realistic?
Replicel timeline
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"The timeline to a commercial product depends on the execution of these trials and regulatory approvals. Nevertheless, if the technology proves safe and effective, RepliCel anticipates that a commercial product may be available in 2015 in non-Western jurisdictions." - This was posted 5 months ago.
In another comment, they also said this:
"RepliCel anticipates initiation of its Phase II study in the second half of 2013 which will be followed by a Phase III trial. The timeline to a commercial product depends on the execution of these trials and regulatory approvals" - This was posted 5 months ago.
However, that phase 2 trial has since been delayed to begin early 2014 according to their website:
"RepliCel is planning to file a clinical trial application (CTA) with the Paul-Ehrlich-Institut, the German competent authority for human clinical trials in Germany, in the first half of 2014. The company is pleased to announce plans to work with one of the largest hospitals in Europe for this trial; the Charité-Universitätsmedizin in Berlin. RepliCel anticipates initiation of this trial early 2014."
And according to the same page, this trial will last 3 years:
"RepliCel’s Phase II trial for RCH-01 is designed to be a dose-finding study which will assess the optimal number of cells and the appropriate treatment regimen necessary to promote hair growth. Subject to regulatory approval, the company is planning to initiate a three year clinical trial that will include multiple subject cohorts studying different doses of RCH-01. Each subject will receive injections of several different doses of RCH-01 and placebo, while some cohorts will receive repeat injections at a future time point."
So, in truth, it seems like it will be later than 2015. To be honest, their results were nothing special so far (so lets hope they improve them by upping the dosage and regularity of treaments), Histogen's HSC seems more effective and more likely to be released around 2015/2016 in Asia. -
That graphic is wrong.
Read this:
'Phase II: Proposed Clinical Trial'
'the company is planning to initiate a three year clinical trial'
'RepliCel anticipates initiation of this trial early 2014'
all 3 quotes from that page.
So Phase 2 might finish in 2017.
After that they would need to fund and start Phase 3.Comment
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Honestly I want to get on board with replicel but what is with all this imprecision? It's hard to take a company seriously--particularly a science based company--when their claims never hold any water.Comment
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well, considering they are gonna sell it actually means it will be out there quicker.
I don't know much about the company, but consider the following. They do not have a vast distribution network or production to cope. With bidders/licenses more people can get this cheaply and quickly due to market competition.
Basically, I do think less money spent on production and establishing distribution means more money spent towards research. And less time spent on establishing how to profit directly to the consumer means its on the market a lot sooner. Remember, they only have to sell it to the tens of thousand of pharmaceuticals manufacturers out there. Not really worrying about the 10s of millions of people they need to bring in the bacon, it lightens the load.
Microsoft windows, sure they sell to the consumer with OS discs, but they make all their money from dell,hp,sony, ect licensing their OS. That's why Apple was so weak during the mid 90s, they wanted to sell and make everything from hardware to software. which lessened their penetration and their prices reflected that. Even now Apple is still suffering from failures of the past, Samsung vs apple. Apple just fails to beat Samsung pre-establish distribution. Why? Because they started growing as a company in a big way in the early 2000s. Samsung has always been a major player.
I hope with that example it makes sense why licensing their product is actually good for us.Comment
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From what I understand, Replicel's formula is fairly standard hair cloning/multiplication. Take cells from the back of the head, culture, inject into bald and thinning scalp with growth factors. But it only yields something like 6% regrowth. Even Dr. Nigam could probably do as well as that..
So basically what I'm saying is don't worry too much about whether this gets released soon. If it got released right now it would be pretty useless - they need to improve it significantly. If I was them, I'd go back to working on the science, and come up with a replicel 2.0 (assuming they can't change things up half way through trials) aimed at being a full hair multiplication solution; designer hair, just like Aderans originally planned. Then they can focus on competing with the other potential full cures that won't be available until 2020ish. Because right now, they'll be competing with HSC which performs much better, and they'll be on the level of Nigams in terms of efficacy I'd bet (maybe even worse by release, if he improves it).Comment
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From what I understand, Replicel's formula is fairly standard hair cloning/multiplication. Take cells from the back of the head, culture, inject into bald and thinning scalp with growth factors. But it only yields something like 6% regrowth. Even Dr. Nigam could probably do as well as that..Comment
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Can we please drop discussions about Dr. Nigam? So far in over a years time he's shown nothing more than very dubious results with help from photoshop. Nothing he's 'able to do' has been verified and his own evidence isn't credible. The guy needs to be completely dismissed until Dr. Mwamba confirms.Comment
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can we please drop discussions about dr. Nigam? So far in over a years time he's shown nothing more than very dubious results with help from photoshop. Nothing he's 'able to do' has been verified and his own evidence isn't credible. The guy needs to be completely dismissed until dr. Mwamba confirms.Comment
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