Send a letter to FDA, Congress, and others to fast track Setipiprant

Mach

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Getting out of the shower this morning and staring at my thinning hair I thought about sending a letter out to fast track Setipiprant.

I was having major issues with my Harley and I sent out 2 letters to the CEO and Manager of North America. I got a call from HD and we talked about my concerns.

Anyway, we should draft a letter to fast track Setipiprant. Address the health benefits of Setipiprant vs Finastride.

Worth a shot? I'd send this on my own but I would look like a goof sense I don't know much about the drug.
 

Dench57

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You know guys can buy it if you want it enough? Would be a hella lot better for your hair than sending a letter to the FDA.
 

username425

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Good idea. Someone should thoroughly study the 21st Century Cures Act, see how it could apply to Setipiprant and how fast the drug could come to market if so.

The bill hasn't been passed by the Senate, but it has been read on the floor twice and referred to a Committee, which is a good sign. It did pass with bipartisan support in the House though.

At first glance it looks like it drastically reduces the timeline for clinical trials. I'll look into the actual text today. It should do me some good because in my second year of law school I probably have done more medical research than law since my hair loss started in July lol.
 

eenrak

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Man, people are really sure this stuff works. As far as I can deduce from the trial people on this forum is that they have either all died or collectively decided not to spread the knowledge, for what ever reason.
 

Kidbako

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Man, people are really sure this stuff works. As far as I can deduce from the trial people on this forum is that they have either all died or collectively decided not to spread the knowledge, for what ever reason.

It is part of the protocol needed for re growth..
 

username425

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Lol. That's great news. As a law student you'd be able to digest and explain it to us in simpler terms. Look forward to this!

uber,

I took a look at this for a few minutes today. I plan on doing more research on it but there does seem to be some room here for an expedited process, if a ton of things go right. I'm in the process of moving to a new place by the end of the month and I'm a little behind with school **** so like I said, I'll have more soon.

The biggest hurdle, at first glance, would be convincing the regulatory body that male pattern baldness is a "serious or life-threatening disease" pursuant to the Federal Food, Drug & Cosmetic Act. However, that act does not define what constitutes a serious or life threatening disease. I will have to do some more digging on whether male pattern baldness is "serious" in the eyes of the law. (Obviously to all of us it is life-threatening).

Again, I have to do a lot more research, and it hasn't even been passed in the Senate yet, and the government will probably shut down next week it looks like due to some Tea Party BS.

The Setipripant is exciting though, from what I've seen about how the company is structured and how they are getting their funding. Hope is dangerous, but optimism can do wonders for the psyche.
 

Jaym

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BTW the FDA categorises hair loss as a disorder not a disease. I don't know if that makes any difference.

But keep reading into the act because it isn't just about fast tracking treatments for life threatening or serious diseases.
 

wilson2

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I think guys are getting a little too optimistic about Setipiprant. I mean believe me I hope to sweet God this is as a good as it seems. I just feel male pattern baldness makes the community at large very invested or better yet desperate for a cure. I think this is why there are so many sham products and BS, because we are a vulnerable market.
 

Dench57

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I think guys are getting a little too optimistic about Setipiprant. I mean believe me I hope to sweet God this is as a good as it seems. I just feel male pattern baldness makes the community at large very invested or better yet desperate for a cure. I think this is why there are so many sham products and BS, because we are a vulnerable market.



:')
 
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