Replicel

[ing]

Im not so clear about the upcoming annoucement so its actually an announcement of phase1 not 2? If thats the case then are we looking to the next 10 years maximum for the miracle?

[DepressedByHairLoss]

I actually think that they know that Phase I/IIa is already successful because I believe they've already started recruiting people for Phase IIb. And since they're not conducting clinical trials in the U.S., they don't need to recruit hundreds of people for Phase IIb and thousands of people for Phase III, so the process will move a hell of a lot quicker, thankfully. I've really got nothing but high hopes for for Replicel (and Histogen too)...

[VictimOfDHT]

So, what's the latest from Histogen? Haven't been coming here a lot lately. Anything good or are they on the way out?

[bananana]

So, what's the latest from Histogen? Haven't been coming here a lot lately. Anything good or are they on the way out?

Nothing new on their site about HSC, there are some news however - http://www.histogen.com/aboutus/news_events.htm

I think they should definitely update their site more often (and more important)
- work HARDER on development.

[Kiwi]

I actually think that they know that Phase I/IIa is already successful because I believe they've already started recruiting people for Phase IIb. And since they're not conducting clinical trials in the U.S., they don't need to recruit hundreds of people for Phase IIb and thousands of people for Phase III, so the process will move a hell of a lot quicker, thankfully. I've really got nothing but high hopes for for Replicel (and Histogen too)...

I hope you're right!

[Pate]

Im not so clear about the upcoming annoucement so its actually an announcement of phase1 not 2? If thats the case then are we looking to the next 10 years maximum for the miracle?

It's a combined Phase I/IIa... Phase I is safety, IIa is I think usually dose-ranging with efficacy as a secondary endpoint.

But realistically a bare minimum of one year for the IIb and the III... if they have to do multiple IIbs like Aderans, who knows how long it could be. They will also have to do a pretty major capital raising before they can afford a Phase III. Hopefully the Phase II results are good enough that they can attract investors without any problems.

[lpenergy]

So, I caught a little bit of Spencer's last interview, and on the tail-end, it sounded like the next interview date will be shortly after the release date of the phase 1 efficacy results.

[lpenergy]

Meant to say Radio Show instead of Interview

I Meant to say Radio Show instead of Interview

[DepressedByHairLoss]

It's a combined Phase I/IIa... Phase I is safety, IIa is I think usually dose-ranging with efficacy as a secondary endpoint.

But realistically a bare minimum of one year for the IIb and the III... if they have to do multiple IIbs like Aderans, who knows how long it could be. They will also have to do a pretty major capital raising before they can afford a Phase III. Hopefully the Phase II results are good enough that they can attract investors without any problems.

I don't that Replicel's clinical trials will be nearly as long as Aderans's since they spent something like 8 years researching their methods to make sure that they were effective. I don't think Aderans had that much pre-clinical research involved since they inherited their technology from another company, Intercytex. I am not sure that Replicel will need major capital raising before they can afford Phase III. Since they are conducting their trials outside of the Western world, they don't need to enroll thousands of subjects like they would have to in the U.S. or Canada. Also, their technology is very simple so that they wouldn't need to spend nearly as much money on facilities, training of personnel, or employment of personnel to administer their procedure. In the article that I am linking at the bottom of this paragraph, refer to page 15, which illustrates this. http://www.*************/research/nb...NCE_REPORT.pdf

What I am really worried about is Replicel outsourcing their technology to a large pharmaceutical company. Since these large pharmas's prime objective is to make money, I'm afraid that they will make Replicel's potential cure into a treatment that one needs to keep coming back for. After all, a lifetime treatment will make a big pharma a hell of a lot more money than a one time cure, which Replicel has the potential of being.

[DepressedByHairLoss]

Lastly, where the *'s exist in the link, type in "equities dot com".

[Maradona]

I don't that Replicel's clinical trials will be nearly as long as Aderans's since they spent something like 8 years researching their methods to make sure that they were effective. I don't think Aderans had that much pre-clinical research involved since they inherited their technology from another company, Intercytex. I am not sure that Replicel will need major capital raising before they can afford Phase III. Since they are conducting their trials outside of the Western world, they don't need to enroll thousands of subjects like they would have to in the U.S. or Canada. Also, their technology is very simple so that they wouldn't need to spend nearly as much money on facilities, training of personnel, or employment of personnel to administer their procedure. In the article that I am linking at the bottom of this paragraph, refer to page 15, which illustrates this. http://www.*************/research/nb...NCE_REPORT.pdf

What I am really worried about is Replicel outsourcing their technology to a large pharmaceutical company. Since these large pharmas's prime objective is to make money, I'm afraid that they will make Replicel's potential cure into a treatment that one needs to keep coming back for. After all, a lifetime treatment will make a big pharma a hell of a lot more money than a one time cure, which Replicel has the potential of being.

I really want to get my hands on this replicel stuff right now.

Assuming replicel is succesful and all goes as planned, how long till we see it in market? I'm guessing around 2018. I'll be an uncureable norwood 6, if not, 7 by then....let alone be alive lol.

That's the only thing that worries me for these treatments coming down the pipe. Even if they did work....we are still screwed...well at least the old dudes

[DepressedByHairLoss]

I hear ya, Maradona. I feel the same way. As enthusiastic as I am about this new treatments, I don't want to live another day with male pattern baldness. I don't want to wait like 5 years (although I don't think it will be that long) for a successful treatment/cure, but in the meantime live life as a man suffering from hair loss. It is unbearable to me and I want something that will work right now (and I'm not talking about the shitbag treatments like minoxidil, finasteride, and hair transplants). It's just so frustrating because a lot of of us would pay top dollar and travel anywhere to do anything meaningful to regrow our hair, but we're not given any options to do so.

[Maradona]

I hear ya, Maradona. I feel the same way. As enthusiastic as I am about this new treatments, I don't want to live another day with male pattern baldness. I don't want to wait like 5 years (although I don't think it will be that long) for a successful treatment/cure, but in the meantime live life as a man suffering from hair loss. It is unbearable to me and I want something that will work right now (and I'm not talking about the shitbag treatments like minoxidil, finasteride, and hair transplants). It's just so frustrating because a lot of of us would pay top dollar and travel anywhere to do anything meaningful to regrow our hair, but we're not given any options to do so.

Yeah man....best thing we can do is try to live our lives to the fullest (at least try)...then if one day a treatment comes...we can use it. Being depressed (like me) all the time will not impact the release date of this treatment, it will only do me worse.

[Pate]

I don't that Replicel's clinical trials will be nearly as long as Aderans's since they spent something like 8 years researching their methods to make sure that they were effective. I don't think Aderans had that much pre-clinical research involved since they inherited their technology from another company, Intercytex. I am not sure that Replicel will need major capital raising before they can afford Phase III. Since they are conducting their trials outside of the Western world, they don't need to enroll thousands of subjects like they would have to in the U.S. or Canada. Also, their technology is very simple so that they wouldn't need to spend nearly as much money on facilities, training of personnel, or employment of personnel to administer their procedure. In the article that I am linking at the bottom of this paragraph, refer to page 15, which illustrates this. http://www.*************/research/nb...NCE_REPORT.pdf

I really do hope you're right... but I disagree with a few of your points. This is just my opinion of course but:

- They spent 8 years in pre-clinical but that does not guarantee they will only need one Phase IIb. There is simply no substitute for human trials. It may simply mean that where Aderans needed five Phase IIs (or whatever it was), Replicel only needs four. Let's wait and see what the results are next month, then we will have a better idea.

- Aderans didn't really 'inherit' their technology from Intercytex. They bought Intercytex during the latter's liquidation but they were already independently pursuing their own technology. They bought ICX in March 2010. By that time they had already put 100 patients through Phase II trials!

- You said "I am not sure that Replicel will need major capital raising before they can afford Phase III. Since they are conducting their trials outside of the Western world, they don't need to enroll thousands of subjects like they would have to in the U.S. or Canada." I don't think this is necessarily true. The fact they are conducting their trials overseas in no way means they need fewer participants than otherwise, particularly since a) Replicel have said they are committed to following proper trial protocols and b) if they want to get it approved in the US and Canada they need to satisfy FDA approval protocols regardless of where the trial takes place.

- Likewise even though it will be cheaper than developing a new drug I don't think it'll be as cheap as that equities dot com document suggests (great find by the way - it's a great summary of Replicel overall). Again, this will depend on how much extra work they need to do.

What I am really worried about is Replicel outsourcing their technology to a large pharmaceutical company.

I totally agree with you here though. They will almost certainly have to go into an industry partnership with someone. In fact I don't know which I dread more - that they'll go into a partnership with a Big Pharma company or they go into a partnership with a Bosley-type company.

Anyway. It's all just speculation until we get some concrete results. I know some of the other guys here get annoyed with us always churning the same stuff over again, but hey... if it helps us cope til we have some info, where's the harm...

There are a couple of other interesting points in that document. They are assuming 2015 as a start date (which is great) but they are assuming revenue to Replicel from each procedure $15k. That means the cost of the procedure paid by the patient would be much higher than 15k because it doesn't take into account the doctor's expenses or the doctor's profit margin. I hope it'll be a bit cheaper than that, especially if we need multiple procedures!

[stillinHS1994]

http://www.foxnews.com/health/2012/03/21/scientists-identify-protein-responsible-for-male-pattern-baldness/

Saw this today...thought you guys might want to see it

On a side note my senior prom is in a few weeks...should be fun rocking the receding hairline and only 18....ugh