Histogen Update from Ziering Medical

[bigentries]

Well the whole slow/expensive clinical trials/FDA approval process could be directly or indirectly assigned blame to the failure of those companies, whichever way you look at it. If it was much cheaper and faster, they could all have had a product on the market within a few years and been turning a profit.

I posted a thing a while ago about a company that is trying to disrupt the clinical trial process, massively reducing both cost and time.

http://www.xconomy.com/boston/2013/04/16/re-thinking-clinical-trials-for-the-world-of-crowdsourcing/

All the FDA needs to do is take a look at their system of doing things, and intelligently re-evaluate it for the 21st century. They could save millions of lives, cure thousands of different conditions, create a biotech spring.

I hear Japan is working on legislation to do something similar with it's trial and approval process. Asia as a whole is much more accepting of new therapies, which is why you don't need to do a phase III trial to sell there. The FDA is a bit of a dragon holding up the development and innovation of new treatments in the USA, and I hope they take a serious look at themselves and follow Asia's example.

Again, not defending the FDA, since it has been proven to be corrupt, and definitely needs some reform, also, a lot of the blame is due to the nature of research funding in the US, we incentivize research, not invention

However, I think that people are vastly overrating the blame of the FDA, if places like Cuba, China, India, etc. that have way more lax laws on research haven't advanced hair loss treatments, it's probably because the current knowledge about hair loss is very limited, and not because bureaucracy is stopping things

I see people complaining about the way trials are done in the FDA, but never point out what is exactly wrong and who is doing it better and how, from that I can only read it as people proposing completely unethical trialing of drugs and procedures

[HairBane]

I keep reading the FDA blaming

Has a researcher came out and proclaimed that FDA is the reason Aderans, Intercytex or any other potential baldness treatment failed?

What is the other option? Besides going fully unethical with human experimentation

This is sounding like those weird conspiracy theories about the electric car, where no single serious researcher was involved

Well the whole slow/expensive clinical trials/FDA approval process could be directly or indirectly assigned blame to the failure of those companies, whichever way you look at it. If it was much cheaper and faster, they could all have had a product on the market within a few years and been turning a profit.

I posted a thing a while ago about a company that is trying to disrupt the clinical trial process, massively reducing both cost and time.

http://www.xconomy.com/boston/2013/04/16/re-thinking-clinical-trials-for-the-world-of-crowdsourcing/

Transparency Life Sciences (TLS) is a drug development company and a leader in the effort to embrace open innovation in clinical development. Tomasz Sablinski, the company’s CEO and founder, is calling for transparency in clinical trials to improve study design, quality and outcomes while drastically reducing costs. With recent clearance by the FDA of its Investigational New Drug application to assess lisinopril as an adjunct treatment for multiple sclerosis, TLS is embracing the power of disruption. Sablinski’s goals are universal and his success would be revolutionary. TLS aims to cut clinical development costs by 50 percent initially, with an ultimate goal of 80 percent savings, along with designing better trials and producing better outcomes. That’s high-impact, groundbreaking change."

All the FDA needs to do is take a look at their system of doing things, and intelligently re-evaluate it for the 21st century. They could save millions of lives, cure thousands of different conditions, create a biotech spring.

I hear Japan is working on legislation to do something similar with it's trial and approval process. Asia as a whole is much more accepting of new therapies, which is why you don't need to do a phase III trial to sell there. The FDA is a bit of a dragon holding up the development and innovation of new treatments in the USA, and I hope they take a serious look at themselves and follow Asia's example.

[bigentries]

I keep reading the FDA blaming

Has a researcher came out and proclaimed that FDA is the reason Aderans, Intercytex or any other potential baldness treatment failed?

What is the other option? Besides going fully unethical with human experimentation

This is sounding like those weird conspiracy theories about the electric car, where no single serious researcher was involved

[James7]

It would be sort of embarrassing if I end up moving to mars, but have a bald scalp because the FDA delayed all the stem cell therapies for years. Maybe that's what happened to Picard - he was just waiting for the FDA to approve hair multiplication.

Haha good one

[hellouser]

Yeah, Elon Musk thinks we'll have the technology to ship millions of people to Mars and millions of tons of cargo there in about 10-12 years. It would be sort of embarrassing if I end up moving to mars, but have a bald scalp because the FDA delayed all the stem cell therapies for years. Maybe that's what happened to Picard - he was just waiting for the FDA to approve hair multiplication.

Like I said elsewhere, no biotech should be doing any of their clinical trials in USA. FDA is a joke and will only SCREW the biotech's plans.

Anyone know WHY the FDA is so ass backwards?

[HairBane]

Wasn't this stuff always proposed for release on the Asian market for 2014/15 or 2016 at the earliest? And perhaps it just might be still? As for the US, to hell with that, we'll probably have transport vehicles capable of intergalactic travel before the FDA crowd ever give the thumbs up to such a treatment for MPB

late 2015 - early 2016 still seems feasible IMO, but they would have to begin their final phase 2 trials within the next few months and start doing whatever negotiating/paperwork needs to be done to secure a pan-Asian release on completion of phase IIb right now. Let's hope they know what they're doing and have enough funding to pull it off. I'm sure they have an ambitious plan.

Yeah, Elon Musk thinks we'll have the technology to ship millions of people to Mars and millions of tons of cargo there in about 10-12 years. It would be sort of embarrassing if I end up moving to mars, but have a bald scalp because the FDA delayed all the stem cell therapies for years. Maybe that's what happened to Picard - he was just waiting for the FDA to approve hair multiplication.

[Dav7]

Wasn't this stuff always proposed for release on the Asian market for 2014/15 or 2016 at the earliest? And perhaps it just might be still? As for the US, to hell with that, we'll probably have transport vehicles capable of intergalactic travel before the FDA crowd ever give the thumbs up to such a treatment for MPB

[UK Boy]

[QUhbale;164551]Did they tell you this directly?

Don't mean to put a downer on it but that means nothing. A rep from Aderans informed a poster on here that Ji-Gami was continuing as normal even after it had been discovered is was being discontinued.[/QUOTE]

I haven't been on the website for weeks due to there being nothing worthwhile to read for quite sometime prior. I saw this thread and upon reading the msg from Ziering I immediately made the conclusion that Ryan555 has confirmed - Ziering are referring to their own physician sponsored trials. I know this because I contacted them last year to find out if they would be doing more and their response was the same.THEY are not intending to carry out any more trials and take the opportunity to try an push shitty prp/acell. They DO NOT state that HISTOGEN have no further trials planned! Ziering DOES NOT = HISTOGEN! Why do people get confused by this?! And then spread false info and start claiming the end of the world. The post also stated approval takes 5-7 years, as others already said that referes to the general approval timelines not saying they will take another 5-7 years. The thing to take from this post is GOOD news, Histogen's treatment has effect for longer than 2 years! I am worried about Histogens results as two well respected hair transplant docs (Cole & Hassan) have said they are not impressed with presentations but I still will try it when it becomes available even if just to maintain.

Hellouser does make some good contributions (RU guide and involvement in demerolling thread) but he also gets carried away on certain topics and I think he needs to spend more time away from this site for his own sake.

[Scientalk56]

I spoke to Histogen. HSC is NOT shelved and they are moving forward.
Now everyone relax.

Yeah but my hair is not going to relax...He is moving forward too and shedding. When i get to norwood 7 Histogen won't be relevant.

Histogen for me is dead...

[robodoc]

You still have your frame do you? Wait until you turn slick, come back here and tell me the change is not dramatic.

Fill up the third front can completely change a person's look. Of course you don't know that because you're still a NW3.

Yea, that frame can help SOME people but HT is not for everyone like the hair docs like to imply. Take the pro basketball coach who looked ridiculous with his HT. He had the grafts removed.

[locke999]

You don't think rationally, do you?

Alright fine, you get a good part of your hair back. Then what? You continue to to go bald, and the other areas continue to thin out and eventually turn slick bald. That single and very costly hair transplant doesn't do jack shit. Some guys don't even respond to Finasteride.

But hey, looks like your method is 'good enough' for everyone! Let's all throw our hands in the air with praise because you've figured out a way to do a hack job treatment for hair loss using archaic methods!

My god.

What do you want us to do. Whine and complain with you on this forum at every chance we get like you do? How does this help at all? If you put as much effort as you do in complaining on these forums into actually getting into a lab and finding a cure, maybe you might just beat all these researchers who you insult so much to the cure.

I'll patiently wait okay?

[hellouser]

Yeah, a post like this just cries out for more information. What exactly did you ask them and what did they tell you? Did they confirm that phase IIb has started yet?

Doesn't matter what answer they give unless its 'we're releasing the product in....' or 'we're closing development'. Everything else is corporate bullshit. Only way to get a straight answer from them is to force it out of them or have their computers and pull out data from there.

Take everything they say with a grain of salt unless its 100% confirmed.

[Thinning@30]

Originally Posted by ryan555 View Post
I spoke to Histogen. HSC is NOT shelved and they are moving forward. As I presumed, Dr. Ziering was stating simply that he is not enrolling any more patients in his own sponsored trial. That does not mean they have given up, not by any stretch.

Your frustration is understood but I can personally attest to the credibility of the people running Histogen. They have a very good product and a great management team, these things just take a long time. Now everyone relax.
Ryan, I would like to know the specific details about this.

How did you contact Histogen, did you do it via email, phone, or their website? Who were you in contact with?

You can't just say "I spoke with Histogen and everything is okay."

Yeah, a post like this just cries out for more information. What exactly did you ask them and what did they tell you? Did they confirm that phase IIb has started yet?

[rdawg]

I don't think Dr. Naughton has time to keep the public updated on every move they're making, nor to field every rumor that surfaces on the Internet. I would assume much of the communication is also curbed by the FDA during this process. It's a long and tedious process.

she doesnt have time to tell us that they are trying to move forward with phase IIb?

it's been silence for months, we had the investment, then that dissapeared, IIb should've been started almost a year ago!

[ryan555]

Amen to that first paragraph. I'd rather hear from Mrs. Naughton about how they are moving forward. They know that they have something potentially revolutionary and they're not just simply gonna shelve it.

I don't think Dr. Naughton has time to keep the public updated on every move they're making, nor to field every rumor that surfaces on the Internet. I would assume much of the communication is also curbed by the FDA during this process. It's a long and tedious process.