2013

[mjolnir]

Hereditary hair loss is a natural and normal process. It is unreasonable to expect that any "natural remedy" would be able to do anything meaningful to stop or slow down a natural process.

I generally like your posts, but I have to be a bit nitpicky with your logic here. Life is a natural process, but there are plenty of natural substances that will end it pretty quickly. For that matter, what's not a natural process? Even cancer is a perfectly natural process in that every human being, if they lived long enough, would eventually get it; that's just the way our biology works. Doesn't mean it's not a disease, though I'll admit that cancer isn't getting cured by saw palmetto. But there are plenty of other, less serious ailments which have been treatment by natural means for hundreds of years.

Now I'm certainly not saying that there are any natural remedies which actually work for hair loss, but in principal, it's entirely possible that there's some jungle plant just waiting to be discovered which would do everything we want just by adding it to our afternoon tea.

[Thinning87]

that would be awesome

[Desmond84]

OK guys, it is now 1st of June 2013 and we have a slightly better picture of timelines compared to 12 months ago!

So what are your opinions now on timelines? Here's mine and I'm very interested to hear your opinions...Also, plz add any upcoming therapies that I may have missed:

- Aderans: Although coming first in the race, has shown mediocre results which makes it difficult to justify the cost of this therapy being in $20,000 mark! If they stay with what they have we should see Ji Gami approved sometimes in 2016. But then who wouldn't wanna wait for CB which is far cheaper and just as effective!

- Replicel: believes it still has a fighting chance and is giving it another shot! They are aiming to finish Phase IIb by June 2015, start Phase III by early 2016 and have a marketable product by early 2018! (Asuming Phase III will take approx 18 months + 10 months to gain FDA/TGA/EMEA approval)

- Histogen: For some reason, Histogen has slowed down in their efforts to bring their HSC product to the market! Their Phase I/II finished over 6 months ago, but they have not provided any updates on their upcoming milestones...At this point they still have to conduct a 18 month Phase IIb trial + 18 months Phase 3 trial + 10 months approval! Assuming they start Phased IIb by early 2014, they should also become available by early 2018. (With regards to early Asian release, that may happen hopefully by late 2016 if they speed things up, which is not looking well)

- CB-03-01: Cosmo Pharmaceuticals will start Phase II in Q1 2014 and is set to conclude by June 2015. A 12 month Phase 3 should then begin by Q1 2016 and product approval should occur by Q3 2017.

Unfortunately, looks like we are still 5 years away from any real changes to our current Gold standards (Big 3)...a bit frustrating!

[UK_]

In conclusion: 20 years, zero progress.

[Desmond84]

You know if you look at the historical records of these treatments:

Back in 2010: Aderans & Histogen believed they'll have their products on the market by 2014.

In 2012: Histogen & Dr Ziering hoped to have this product by 2016

It is now 2013: and late 2017- early 2018 is our best bet!

The whole drug approval process needs to be re-assessed to allow for new therapies to reach patients in a much faster manner. Taking 10-12 years + 1-2 billion dollars is an extremely inefficient process and surely can be done better in the technologically crazed societies of 21st century!

This is the greatest problem with advancements in medical therapies compared to the rapid and exponential growth of Information technology!

We really need to find a better way to assess Drug safety!

[UK_]

Big pharma wont listen, it's taken people close to a century to convince them that marijuana has medicinal properties.

[Desmond84]

We need a maverick Scandinavian country to come up with a new way to test for Drug Safety and abolish the pain staking task of conducting a 10 year pre-clinical and then clinical Phase I, II, III trials!

Hopefully, with Dr Lauster's microchip technology pre-clinical studies can be conducted at a much more rapid pace!

The THREE phase trial system is the result of a 20th century methodology, which although is very sound and robust has considerably slowed down release of 1000's new therapies to the market, due to the cost of conducting such trials!

The rate of NEW drug molecules being approved has declined by over 70% since the early 90's due to this very problem many Pharmaceutical companies are facing.

I personally don't blame Gail's frustration with sourcing funds to continue with her trials....

[Desmond84]

Once we can grow organs in a lab...Pharma labs should be allowed to simply have Kidney, Liver, Heart, Lung models that they get to test their products on! If all is good, there is no need for Phase I and II trials!

A Pharma company should conduct a small 6 month dose range finding study followed by a 12 month large scale Phase 3 study!

All in all...human trials should NOT exceed 2 years

[drnigams]

DESMOND,
Gerd and his company partners are into similar ambitious project..to create mini body organ systems with minimum cells and tissue with blood vessels in lab ,in microchip with bioreactors...i had a look at it when i was at thier lab..

They are right now developing blood vessels in vitro in lab..rest they
have..and than it is upto fda to recognise this is safe model..for testing clearance..for humans or atleast avoid animal testing...

Once we can grow organs in a lab...Pharma labs should be allowed to simply have Kidney, Liver, Heart, Lung models that they get to test their products on! If all is good, there is no need for Phase I and II trials!

A Pharma company should conduct a small 6 month dose range finding study followed by a 12 month large scale Phase 3 study!

All in all...human trials should NOT exceed 2 years

[DepressedByHairLoss]

We need a maverick Scandinavian country to come up with a new way to test for Drug Safety and abolish the pain staking task of conducting a 10 year pre-clinical and then clinical Phase I, II, III trials!

Hopefully, with Dr Lauster's microchip technology pre-clinical studies can be conducted at a much more rapid pace!

The THREE phase trial system is the result of a 20th century methodology, which although is very sound and robust has considerably slowed down release of 1000's new therapies to the market, due to the cost of conducting such trials!

The rate of NEW drug molecules being approved has declined by over 70% since the early 90's due to this very problem many Pharmaceutical companies are facing.

I personally don't blame Gail's frustration with sourcing funds to continue with her trials....

Maybe Dr. Nigam's new technologies for hair regrowth can be released in India without these retardedly extensive clinical trials. I would travel to India in a second if there was proof that my hair could be regrown without surgery.

[StinkySmurf]

The THREE phase trial system is the result of a 20th century methodology, which although is very sound and robust has considerably slowed down release of 1000's new therapies to the market, due to the cost of conducting such trials!

libertarians are gaining ground very quickly in the USA right now. if they win control of the white house in 2016, it could mean more rapid changes to the FDA.

[Thinning87]

libertarians are gaining ground very quickly in the USA right now. if they win control of the white house in 2016, it could mean more rapid changes to the FDA.

yeah right

[rdawg]

FDA rules while understandable are just a little too slow.

IMO should be a two phase(maybe 2.5) system, 1st phase is safety and efficacy for one year, second phase 1.5 years tested similar to a phase III.

then limited release for a year for safety purposes(say in select big markets), then full release after that.

right now it's alot of phase I/II, then IIb, the IIb again! then III and bam 5 years go by with barely anything done!!!

[StinkySmurf]

yeah right

it depends on what you want to call a libertarian I guess. If your definition is someone who wants a less cumbersome FDA, then I would say the chances are better than 50/50 that a libertarian is elected to the white house in 2016.

I think the rules even relaxed under Obama for life threatening conditions so it's not a shocker

[young]

What I don't understand is why the FDA is having such a big part in this. There are far more advanced and efficient countries than the US...

And what about the ones that arent? Surely, all these brilliant scientists could have labs in an obscure country where they can try out this stuff without all the bullshit.

Now there's a thought... Lol. Some shady island... Go there to join the Hair Club. Just like Fight Club, except you get a NW0 instead of an ass whooping. 50k.

No problemo!!!!

Just please someone find the solution so we can make you the richest person alive! I am not demanding anything like I am entitled to anything... But just think about it. Richest person alive. Richest person ever.
Go on!!! You can do it!!