Histogen Update - Spencer Kobren Speaks With Dr. Craig L. Ziering

[Tracy C]

The number of injections it might possibly be does not bother me - as long as their treatment works. They could always map your scalp and create a template, similar to the way prosthetic hair is made, to get the injections right.

[Gjm127]

Sorry for repeating...
So basically now we have to wait till December until we hear from them again?
Till then they'll be done with Phase 2 (0.5 years) and Phase 3 will start (1 year), then FDA approval (1-2 years for USA) and release in Asia (approx. 1 year)?
My estimation: 4.5 years for USA and 3.5 years for Asia?
Does it seem legit?

[2020]

Sorry for repeating...
So basically now we have to wait till December until we hear from them again?
Till then they'll be done with Phase 2 (0.5 years) and Phase 3 will start (1 year), then FDA approval (1-2 years for USA) and release in Asia (approx. 1 year)?
My estimation: 4.5 years for USA and 3.5 years for Asia?
Does it seem legit?

Phase 2 will last a full year - january to december.

Yes, phase 3(if even needed for Asia) will start sometime in 2013 and ends in probably 2014.

2014-2015 for asia and 2015-2016 is not unrealistic at this point.

[john2399]

Phase 2 will last a full year - january to december.

Yes, phase 3(if even needed for Asia) will start sometime in 2013 and ends in probably 2014.

2014-2015 for asia and 2015-2016 is not unrealistic at this point.

I want to know that question too does outside countries need phase 3? i hate how these trials r so dam long

[mjolnir]

Regarding the length of trials, do keep in mind that this is still a very new and experimental treatment. Maybe the FDA does make things take a bit longer than is absolutely necessary - I really don't know - but it's not actually a bad idea to be extra sure that Histogen is safe. I certainly don't enjoy having a bald spot, but at the end of the day this is still a purely cosmetic treatment that we're talking about.

[WashedOut]

I want to know that question too does outside countries need phase 3? i hate how these trials r so dam long

Not all countries require phase 3. This is why they could release in asia sooner if they wanted.

[john2399]

Not all countries require phase 3. This is why they could release in asia sooner if they wanted.

I hope your right. I don't get what phase 3 is for. Phase 1 is primarily for safety and phase 2 is to test efficacy. What do we need phase 3 for ?

[mjolnir]

I hope your right. I don't get what phase 3 is for. Phase 1 is primarily for safety and phase 2 is to test efficacy. What do we need phase 3 for ?

If your treatment results in the agonizing death of 1 out of every 100 patients (maybe they have some rare, recessive gene, for instance), then a 50 person phase 1 trial isn't necessarily going to catch that. A 3000 person phase 3 trial, on the other hand, might. There is actually a reason for the way things are done. I agree it's frustrating, but personally I don't plan on rushing off to Asia the instant this is available.

[doinmyheadin]

If your treatment results in the agonizing death of 1 out of every 100 patients (maybe they have some rare, recessive gene, for instance), then a 50 person phase 1 trial isn't necessarily going to catch that. A 3000 person phase 3 trial, on the other hand, might. There is actually a reason for the way things are done. I agree it's frustrating, but personally I don't plan on rushing off to Asia the instant this is available.

1 in 100 thats on par with finasteride. I think a lot of people would be happy with those odds.

[Follicle Death Row]

The number of injections it might possibly be does not bother me - as long as their treatment works. They could always map your scalp and create a template, similar to the way prosthetic hair is made, to get the injections right.

Exactly. Labour intensive but not moreso than HT already is. Like the mapping out idea.