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Hey hellouser,
What you're referring to are called Phase 4 trials (Post-approval) studies.
First of all, they're conducted after the drug is on the market, so don't worry
you'll get to use it while they're conducting these studies.
Secondly, there are TWO main reasons why these studies are conducted:
1) FDA has asked them to conduct a long-term safety study (for risk of cancer, mortality, etc) which would most probably be the case for a biological drug like histogen that contains Wnt proteins.
2) Companies themselves decide to conduct these studies, to evaluate further potentials of their drug and broaden its indications. This could be things like:
- the compounding effects of 4 treatments at 6 weeks intervals vs. 2 treatments at 6 weeks interval
- how long does their treatment last
-etc
What you're referring to are called Phase 4 trials (Post-approval) studies.
First of all, they're conducted after the drug is on the market, so don't worry
you'll get to use it while they're conducting these studies.Secondly, there are TWO main reasons why these studies are conducted:
1) FDA has asked them to conduct a long-term safety study (for risk of cancer, mortality, etc) which would most probably be the case for a biological drug like histogen that contains Wnt proteins.
2) Companies themselves decide to conduct these studies, to evaluate further potentials of their drug and broaden its indications. This could be things like:
- the compounding effects of 4 treatments at 6 weeks intervals vs. 2 treatments at 6 weeks interval
- how long does their treatment last
-etc
Another good news I can give you "hellouser" is that when you look at a company's study design, you can tell who they're targeting their product for.
FDA is big on "placebo-controlled" trials meaning you have to test your drug against a placebo group.
Europe is more of a fan of "your drug vs. our current gold standard" (i.e. Propecia/minoxidil).
So far, histogen's been conducting a "placebo-controlled" trial, where one side of scalp received Histogen's HSC complex while the other side received a placebo shot!
This most probably means their priority is a US launch. We'll know for sure when we find out the design of their Phase III trials. If its placebo-controlled, FDA will not be too harsh on them and you would see the product in US by 2015-2016 if all goes well.
Hope that clarifies your concerns, and don't hesitate to ask me any questions. I'd be more than glad to help
FDA is big on "placebo-controlled" trials meaning you have to test your drug against a placebo group.
Europe is more of a fan of "your drug vs. our current gold standard" (i.e. Propecia/minoxidil).
So far, histogen's been conducting a "placebo-controlled" trial, where one side of scalp received Histogen's HSC complex while the other side received a placebo shot!
This most probably means their priority is a US launch. We'll know for sure when we find out the design of their Phase III trials. If its placebo-controlled, FDA will not be too harsh on them and you would see the product in US by 2015-2016 if all goes well.
Hope that clarifies your concerns, and don't hesitate to ask me any questions. I'd be more than glad to help
A 2015-16 commercial date sounds reasonable! I'm somewhat lucky because my hairline has receded significantly in the last 8 years causing a big widows peak although my crown hasn't been affected other than thinning (though not noticeable). That said, I could opt out for a Gho treatment or with Dr. Rahal for my hairline and continue my Minox/RU58841 regimen until Histogen or Aderans becomes available which would basically be a permanent solution effectively going back to a norwood 0 or 1.
Thanks again!
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