Sm04554

[nameless]

1. Anti-androgens need to be applied permanently.

2. Let's *assume* anti-androgens grow hair by way of stimulating Wnt.

3. This would mean that the reason you lose hair when you cease anti-androgen treatment is because you stopped taking the anti-androgen that was stimulating Wnt for you.

4. Since the anti-androgen has to be used permanently this seems to mean that Wnts also have to be stimulated permanently or else you could quit the anti-androgen without losing your new hair.

I'm basing all of this on the idea that anti-androgens reverse hair loss by stimulating Wnts.

If anti-androgens regrow lost hair is by stimulating Wnts then it seems to me that this would mean that follicles need permanent Wnt stimulation in order to regrow lost hair or else the follicles wouldn't need permanent anti-androgen therapy in order to regrow lost hair.

If this is all true then I don't see how SM0554 can work after its' discontinued and they're only applying it a few months in the study.

[burtandernie]

Your not going to use SM and just be cured your going to be using it for life instead of propecia most likely. Its funny because Merck tried that type 1 DHT inhitibitor which didnt seem to do that much for hair but of course propecia did. Odd because type 1 is supposedly even more abundant local to hair. Seems dut would stop MPB for almost everyone but it doesnt.
I agree with all your receptor stuff and the WNT pathway having huge potential. My biggest worry is no one knows how far down the rabbit hole goes. There could 20 different factors layered under the WNT pathway or tied into a combination of both. There is no limit to how complicated it could get and that would take our life time to unravel.

[lacazette]

They will finish phase ll in october 2015.

Do you think Samumed is interested in a partnership with a japan company like replicel?

With new japan's laws, they could have an approval market there after just their phase 2 results! They could make money and continue their phase 3 for a worldwide approval.

Since a lot of companies ( not only hairloss) are already planning to do this for all the advantages, I wonder why Samumed could not be interested in every points? no?

If this could be true, we could have a daily Wnt topic before 2016!!

Maybe if a lot of people in all hair loss forums contact Samumed about japan drug approval idea, they will see that they could do benefits really quickly and continue their FDA approval with already money in the Pocket. Aren't you agree guys?

[Arieux]

@lacazette: it would be fantastic for us if Setipiprant was in asian market in this way without phase 3! However, I don't know if Samumed would be interested in a partnership with company like Replicel. This technology constitues the biggest competition to any of antiandrogens. Drugs have to be taken all the time and Replicel would be a permanent solution, as they said:

you no longer have cells that are affected by androgen running in your hair follicle on top of your head. So that is a permanent solution. It’s not like you’re taking a drug, which basically juices the performance of what cells are left, but it doesn’t actually change the inevitable outcome. We’re changing, we’re going to reverse and change the inevitable outcome, so those hair follicles no longer are compromised by androgen.

(source: http://www.midasletter.com/2014/10/r...rview-podcast/ ).

So if someone can afford to fly to Japan in 2018 and take this set of injenctions, he won't be more interested in holding his hair. The only thing he may want to do is to ,,repair'' lost hair by HT. Of course, it is true supposing that Replicel will work exactly as they say. It is my biggest dream: to wake up one day and don't have to think about my worsening hair situation...

[FearTheLoss]

They will finish phase ll in october 2015.

Do you think Samumed is interested in a partnership with a japan company like replicel?

With new japan's laws, they could have an approval market there after just their phase 2 results! They could make money and continue their phase 3 for a worldwide approval.

Since a lot of companies ( not only hairloss) are already planning to do this for all the advantages, I wonder why Samumed could not be interested in every points? no?

If this could be true, we could have a daily Wnt topic before 2016!!

Maybe if a lot of people in all hair loss forums contact Samumed about japan drug approval idea, they will see that they could do benefits really quickly and continue their FDA approval with already money in the Pocket. Aren't you agree guys?

This couldn't be more false, first of all Replicel is a Canadian company, they partnered with Shiseido, which is a Japanese company. Second of all, the Japanese rules don't apply to drugs. Third of all, having the forum contact Samumed will do nothing, because they legally can't do it. Lastly, these guys know what they are doing and don't need any of us here to help, to think that they don't know regulations of different areas around he globe is misinformed.

[lacazette]

"the Japanese rules don't apply to drugs"

I'm not sure of what you claim when I see exemple like this:

ZURICH—Swiss pharmaceutical company Novartis AG said Friday that it won approval in Japan for a new psoriasis drug, the first country to give the treatment a green light for commercialization.


You can google it, and you'll see that it's not the only drug who got a first approval in japan, so I'm sure the process is short there, ( not difficult when you compared to fda)

FOr your first point I don't know what you want to mean? Why Samumed could not have a japan's partnered like replicel did? Why you tell that they legally can't do it?

For the last, yes I know they are aware of all world regulations, I didn't mean to contact them just to tell 'hey look there is japan's laws' lol
But maybe we could have informations on why they don't do that, or if they plan to do that, etc

sorry for my english

[FearTheLoss]

Only stem cell treatments can skip phase 3, not drugs.

[nameless]

This couldn't be more false, first of all Replicel is a Canadian company, they partnered with Shiseido, which is a Japanese company. Second of all, the Japanese rules don't apply to drugs. Third of all, having the forum contact Samumed will do nothing, because they legally can't do it. Lastly, these guys know what they are doing and don't need any of us here to help, to think that they don't know regulations of different areas around he globe is misinformed.

* I think his point may have "some" validity. Yes, I know the new law in Japan applies to cell-based therapies but sometimes there are ways to convince regulators that a drug is cell-based on the basis of the effects it has on the cell. I don't have the exact language of the new Japan law in front of me so I don't know the specifics. Still, it is possible that their drug could be included -it depends on the exact language of the new Japan law.

* Also, even if the new Japan law doesn't apply to SM it's still faster to get drugs through the regulatory process in Japan than USA.

* I contacted Histogen a few years ago to tell them that there are other countries in the globe that move things faster than the USA FDA, and that Histogen could move their product through quicker in those countries WHILE AT THE SAME TIME still moving forward in the USA under the FDA rules, and the folks at Histogen were like "duh". They hadn't even thought of it. They're addicted to FDA. Drug companies want to bring drugs to market in USA so they're all focused on FDA and they aren't thinking outside of the box. It is a good idea to send emails to tell drug companies that they can bring drugs to market sooner in Japan (and other countries) while also proceeding with FDA trials. The drug companies are so focused on FDA approval that they don't think about having milti-tracks - one for FDA and one for speedier countries.

[JayM]

I'm with FearTheLoss here. Although there might be a different process like the new bill being passed so that it is able to make it to market quicker? But I was fairly sure it was only Stem cell treatments that can skip phase 3

[lacazette]

Oh okay so they can't skip phase 3, damn so let's forget the "before 2016" sorry^^

But drugs seems to be approved sooner in japan. Maybe the process is easier than US and we could gain 1 or 2 years if Samumed do a phase3 clinical trial in japan.

well I hope hehe

[JayM]

yeh dude but have you read this new bill which is being passed? I think its American right guys? not sure as I am British so didn't really read it (my bad) but could make it way more of an efficient process and maybe drugs currently in trial could be the first to benefit.

[lacazette]

I just read a bit right now and you're right : some quotes:

"A bill drafted by the House Energy & Commerce Committee's health panel would eliminate the need for randomized, controlled clinical trials, the gold standard for assessing whether a product is safe and effective.
Instead companies could submit data from observational studies, in which researchers have no control over the experiment, ongoing surveillance studies and other clinical experience.

In addition, the FDA would be allowed to approve new indications based on a review of clinical data summaries, rather than full packages, potentially speeding up the approval time.

The bill would also require the agency to consider using real world experience as opposed to randomized trials to support or satisfy requirements for post-market studies.

But companies are required to conduct additional trials to confirm that the expected benefit actually materializes. The bill would reduce the need for such trials.

It would also make it easier for companies to provide economic analyses to insurance companies and others involved in reimbursement.

"If included in the final version of the bill, known as 21st Century Cures",
So the question is when? Any american here who can give us more information?
Im french and not aware of all that, it's the senate who gonna vote for that bill or what?

It could really be a great news if it's happening

[lacazette]

"20 june - House Energy & Commerce Chair Fred Upton (R-MI) has signaled he won't bring his 21st Century Cures bill to the floor next week as he continues to negotiate offsets,...."

Well it's seems that it is not far away. But I'm afraid that the bill won't be accepted because of industry lobbyists or whatever

[It's2014ComeOnAlready]

"20 june - House Energy & Commerce Chair Fred Upton (R-MI) has signaled he won't bring his 21st Century Cures bill to the floor next week as he continues to negotiate offsets,...."

Well it's seems that it is not far away. But I'm afraid that the bill won't be accepted because of industry lobbyists or whatever

From what I understand, everything in the bill is set up to be more beneficial for patients, as well as companies. The whole point of the bill is to develop drugs more quickly, and cheaper. Industry wants this. Patients want this.

There will of course be some hurdles because of negotiations. I wouldn't worry too much.

[lacazette]

So it sounds good for us

What Im wondering is if the bill pass, will all the HL treatments that are currently in clinical trials would benefit of these news laws, or is it too late for them and the new approval system will only concern the futur ones?

And also if the bill pass, in how many months will it be effective? Does it gonna change FDA's things already this year, or will we have to wait mooore longer.

Well if anyone could mail the authors/collaborators of the bill with simply clearly questions it could be cool.
I want to do it but i have a strange English writting, and I don't know how to formulate clearly the questions