Sm04554

[Tenma]

Im not very familiarized with US law but find really unlikely this act will speed up clinical trials for hairloss drugs.

[burtandernie]

Yeah a lot of talk about this bill but no one has any clue what it will really do for specific drugs until they actually start altering timelines and there is a basis to start guessing at other ones. Right now it might not do anything at all for cosmetic drugs. No one knows. I wouldnt count on politicians or laws they pass to do much of anything in speeding up trials. Waiting on new treatments for many years is the worst part of the whole thing especially stuff like CB when there are millions of previous AAs some with similar actions to base safety off of yet 5 years to finish it? I doubt getting a topical delivery system takes that long to do. The phase 3 just kills huge amounts of time and money

[joel203]

Im not very familiarized with US law but find really unlikely this act will speed up clinical trials for hairloss drugs.

agreed

[It's2014ComeOnAlready]

Yeah a lot of talk about this bill but no one has any clue what it will really do for specific drugs until they actually start altering timelines and there is a basis to start guessing at other ones. Right now it might not do anything at all for cosmetic drugs. No one knows. I wouldnt count on politicians or laws they pass to do much of anything in speeding up trials. Waiting on new treatments for many years is the worst part of the whole thing especially stuff like CB when there are millions of previous AAs some with similar actions to base safety off of yet 5 years to finish it? I doubt getting a topical delivery system takes that long to do. The phase 3 just kills huge amounts of time and money

I don't think it's OK to speculate one way or another. You all seem to go according to your mood. The bottom line is that this law will change some protocol for clinical trials in general. They want to add information, i.e. biomarkers and surrogate endpoints. This is as much a health bill as it is an economic one. The point of the bill is also meant to keep innovation in the United States.

Of course all of you believe hair loss will be left out. It's all I hear about on this board. How about keeping a positive outlook for once?

Enough talk, let's just wait and see.

[lacazette]

I read some various articles, saying that the new laws will give so much more freedom to pharma companies and that it will be very dangerous for the safety of the population. And that it would be better to stay like this without especially the suppression of the long phase 3 replaced by biomarkers,etc

So if the bill pass, I don't see why we should be afraid for hairloss drugs as the other cosmetic areas. pharma freedom is all we need. And pharma lobbies are for sure already doing their job to make this bill passed, so no worries to have i think

[TooMuchHairWontKillYou]

better worry about efficacy

If SM fails I will get TE from depression

[nameless]

agreed

I'm not 100% sure but I think you're probably wrong. I even think that the company believes that their drug will be affected by the new law or else the company would not bother trying to secure biomarkers through their additional phase 2 study. I think there's a very real possibility that they hope to use biomarkers in lieu of a phase 3.

[joel203]

I'm not 100% sure but I think you're probably wrong. I even think that the company believes that their drug will be affected by the new law or else the company would not bother trying to secure biomarkers through their additional phase 2 study. I think there's a very real possibility that they hope to use biomarkers in lieu of a phase 3.

I hope you're right

[nameless]

I hope you're right

Don't misquote me. I said I'm not 100% sure.

That having been said, I do not believe that the company intended to do the supplemental phase 2 from the beginning because if they had intended to do the supplemental phase 2 all along then it seems logical that they would have done it as part of the original phase 2. They could have gotten biopsies from their subjects in the original phase 2 study.

So this makes it look to me like this supplemental phase 2 study is something they only recently decided to do.

So the big question is what could have prompted them to do this ad-hoc study which will produce bio-markers? I think that the logical answer to that question is that they're aware of the new FDA law that allows drug companies to use bio-markers in lieu of a phase 3 study.

I also think that this ad-hoc study also makes it seem like they got good results in their original phase 2 study because why would they spend millions of dollars on the ad-hoc supplemental phase 2 study if they didn't see something promising in the original phase 2 study?

[lacazette]

Agreed nameless

And I would add that they're surely planning to hit the asian market by japan's approval

The drug approval is already easier there, and even more easier when it comes to a topical drug instead of an oral
So I suspect a second phase 2 with detailed biomarkers could be sufficient to ask for Japan's FDA approval