Spencer! Aderans.... Now!!!

[KO1]

What does Histogen have to do with taking propecia? Even if Histogen works, it will be a long time before it becomes available. A year off is nothing.

[Breaking Bald]

What does Histogen have to do with taking propecia? Even if Histogen works, it will be a long time before it becomes available. A year off is nothing.

I just mean in general because we anticipated a possible release of 2014/15 for Histogen, doesn't seem like any treatments will be coming in the next few years. So basically I am screwed...

[Desmond84]

Why do you say Histogen are 'taking a year off'?

I'm at a total loss here, I guess I'm going to have to give in to my fear and take propecia...

I'm sorry to upset you BB It was really unintentional...but there comes a time when we have to be realistic and see things for what they are.

I have had experience in clinical trials before and have an idea of the great deal of tasks that must be completed for the next Phase of trials to begin. These range from writing a study protocol, submitting the protocol to all ethics committees at your research sites, get approval for your protocol, recruit patients, etc.

These tasks are solely clinical and in no way have anything to do with a company's funding.

Assuming Histogen still holds sufficient funds to continue with their trials, completing these tasks takes approximately 6-9 months! Generally these companies present their investors with a draft protocol that suggests dosing protocol, number of subjects, primary and secondary endpoints, etc well before the trials are to start. We witnessed such draft protocols with Replicel back in January even though the trials are set to begin in 2014!

Unfortunately, Histogen has not reached any of these milestones which would make it almost impossible to begin trials in 2013.

We just have to be realistic.

[KO1]

I just mean in general because we anticipated a possible release of 2014/15 for Histogen, doesn't seem like any treatments will be coming in the next few years. So basically I am screwed...

I dont think they will start a P3 trial before 2015....then they need to pass that and clear FDA's wise men (safety is a big question mark with HSC)....There's a reason I keep telling people to take fin and not wait for these treatments.

Cosmo will start P2 in 2015 too.

[StayThick]

I'll be completely bald if I wait for these so called treatments to hit the market. A big "if" they ever are released.

I'm starting to looking at FUE transplant options. At 27 I'm a little young, but with my hairline restored and some added density throughout my top scalp I'd be a NW 1.5 at worse after a solid FUE.

Done wasting time. Wish everyone the best.

[Pentarou]

Why do you say Histogen are 'taking a year off'?

I'm at a total loss here, I guess I'm going to have to give in to my fear and take propecia...

Beat the fear! Everyone who has started finasteride treatment has been through the fear stage. Most likely you'll have nothing to be frightened of and wish you'd started earlier. Best of luck, and please do consider starting treatment as soon as you can if you want to save your hair, it's better to act now as fin as little regrowth potential.

[Thinning87]

I'm sorry to upset you BB It was really unintentional...but there comes a time when we have to be realistic and see things for what they are.

I have had experience in clinical trials before and have an idea of the great deal of tasks that must be completed for the next Phase of trials to begin. These range from writing a study protocol, submitting the protocol to all ethics committees at your research sites, get approval for your protocol, recruit patients, etc.

These tasks are solely clinical and in no way have anything to do with a company's funding.

Assuming Histogen still holds sufficient funds to continue with their trials, completing these tasks takes approximately 6-9 months! Generally these companies present their investors with a draft protocol that suggests dosing protocol, number of subjects, primary and secondary endpoints, etc well before the trials are to start. We witnessed such draft protocols with Replicel back in January even though the trials are set to begin in 2014!

Unfortunately, Histogen has not reached any of these milestones which would make it almost impossible to begin trials in 2013.

We just have to be realistic.

That's a little bit different from "taking a year off".

I am amazed at how easily people can confuse their emotions with actual facts and then give rise to negative rumors.

We all knew they weren't going to jump into a new phase right away, so what is all this "taking a year off" talk? You make it sound like they are going on holiday for a year.

[Scientalk56]

Don't wait for any future treatments, life goes on, and won't wait for you. LIFE IS SHORT guys to waste on waiting...
we are blessed to have companies working on treatments right now, but it wont be before 2017..
Beeing Realistic is good - becuase it means you have to deal with what you have and move on

[Desmond84]

That's a little bit different from "taking a year off".

I am amazed at how easily people can confuse their emotions with actual facts and then give rise to negative rumors.

We all knew they weren't going to jump into a new phase right away, so what is all this "taking a year off" talk? You make it sound like they are going on holiday for a year.

Thinning I'm no longer emotional about the cutting edge but objective. The last 12 months have thought me a lot about hairloss and our options. Having spent some years in clinical trial design I can assure you about how things generally unfold with trials.

Companies conducting trials ALWAYS have to make a 'go' or 'no go' decision as they receive their interim trial results as to whether continue with the next phase or not. Generally, if the interim results are solid as was Histogen's back in October 2012, they immediately start to work on the next phase (writing up draft protocol, etc) while the initial trial is still ongoing. This usually leads to a 3-4 month downtime until the next phase starts. Every 'Clinical Research Associate' I know always says "Time is money" as the longer you spend on trials the shorter the patent period will be that you actually have your product on the market! Time management and efficiency is integral to a successful drug approval.

Think about Aderans for example. They conducted 11 Phase 2 trials in 5 years! It would have been impossible to conduct so many trials in 5 years, if they waited 6 months to analyse each final results and another 6 months to write up the protocol for the next Phase 2 trial. If so, it would have taken them over 30 years to finish these 11 trials!

Replicel is another great example that everyone is aware of. Their Phase 2a finishes in Dec 2013 and Phase 2b begins in Jan 2014! They started working on Phase 2b well before Phase 2a ended.

Histogen had a clear picture of their product's efficacy back in October 2012, however we now know that they didn't start acting on this information to plan for the next Phase ASAP. The reasons are only known to Gail and her team and anything we say is speculation. But the facts remain that Histogen will most probably not initiate any trials in 2013.

This leaves the hairloss sufferers in a difficult position as there is no clear picture of product release date or even further delays. So, we would be doing our friends in BTT a huge de-service by giving them false hopes and stopping them from making an integral decision to do something about their hair now rather than in the future.

I just don't want anyone looking back on these days with hindsight and say I wish I didn't wait for these treatments and did something for my hair when I had the chance!

[justeone]

Don't lose hope Fella's , people all over the world are trying to crack this safe.. Aderans was just in the lime light.

[KO1]

So only people left are Follica and Histogen, given Replicel got disappointing results and has a questionable process...

[Thinning87]

Thinning I'm no longer emotional about the cutting edge but objective. The last 12 months have thought me a lot about hairloss and our options. Having spent some years in clinical trial design I can assure you about how things generally unfold with trials.

Companies conducting trials ALWAYS have to make a 'go' or 'no go' decision as they receive their interim trial results as to whether continue with the next phase or not. Generally, if the interim results are solid as was Histogen's back in October 2012, they immediately start to work on the next phase (writing up draft protocol, etc) while the initial trial is still ongoing. This usually leads to a 3-4 month downtime until the next phase starts. Every 'Clinical Research Associate' I know always says "Time is money" as the longer you spend on trials the shorter the patent period will be that you actually have your product on the market! Time management and efficiency is integral to a successful drug approval.

Think about Aderans for example. They conducted 11 Phase 2 trials in 5 years! It would have been impossible to conduct so many trials in 5 years, if they waited 6 months to analyse each final results and another 6 months to write up the protocol for the next Phase 2 trial. If so, it would have taken them over 30 years to finish these 11 trials!

Replicel is another great example that everyone is aware of. Their Phase 2a finishes in Dec 2013 and Phase 2b begins in Jan 2014! They started working on Phase 2b well before Phase 2a ended.

Histogen had a clear picture of their product's efficacy back in October 2012, however we now know that they didn't start acting on this information to plan for the next Phase ASAP. The reasons are only known to Gail and her team and anything we say is speculation. But the facts remain that Histogen will most probably not initiate any trials in 2013.

This leaves the hairloss sufferers in a difficult position as there is no clear picture of product release date or even further delays. So, we would be doing our friends in BTT a huge de-service by giving them false hopes and stopping them from making an integral decision to do something about their hair now rather than in the future.

I just don't want anyone looking back on these days with hindsight and say I wish I didn't wait for these treatments and did something for my hair when I had the chance!

I am not questioning all the difficulties and obstacles that are and will be encountered in the industry by the companies we all want to see succeed.

I am saying the 6-9 months period of reading data and trying to comply to FDA standards (which you call "taking time off") is not only something we all knew about in the past, but you are the very one person that was taking it into account in the past when making deadlines.

Nothing has changed, for all we know Histogen is still the same company it was six months ago with the same deadlines. So the whole "I am switching from positive to neutral" thing makes no sense because no offense it's just moodrings due to what seems lack of progress but really is lack of news.

And I completely understand being pissed off for all this, because I am also bitter to say the least, but let's not give in to our emotions by creating new opinions based on nothing else other than emotions every two months.

If anything, it's not the optimism, but the volatility of the forum that hurts younger crowds new to the threads.

We have had an awesome month of June, totally unexpectedly since we initially hadn't heard anything from the congress in May; I don't need to explain why.

Hang in there people, progress is obviously being made, relax and focus on other aspects of your lives, stuff will eventually come out.

[Pentarou]

So only people left are Follica and Histogen, given Replicel got disappointing results and has a questionable process...

Well, to be fair, their results were good enough to go to the next phase of trials.

Isn't Replicel's treatment approach similar but different to Aderans, incidentally?

[KO1]

Aderans believed in using both dermal and epidermal cells - fibroblasts and keratinocytes, whereas Replicel just uses one cell type - DSC fibroblasts. I think ARI's process was better...and I think that is what Nigam is moving towards.

[ar50]

How long do you think Dr Nigam will need for his treatment?