Sm04554

[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

[Tenma]

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

[It's2014ComeOnAlready]

Thanks 2014. Could you post the article?

http://energycommerce.house.gov/icymi/%E2%80%9Cgroundbreaking-research-offers-best-hope%E2%80%9D

[hellouser]

Will be voted on early next year. I read an article posted yesterday, where a group of senators and congressman tied closely to the bill, speaking to a group of people, saying that they "guarantee it will become law."

Why not just implement it now and stop wasting time?

[JayM]

Thanks 2014. Could you post the article?

[It's2014ComeOnAlready]

American guys - has there been any news on 21st century cures act?

Will be voted on early next year. I read an article posted yesterday, where a group of senators and congressman tied closely to the bill, speaking to a group of people, saying that they "guarantee it will become law."

[JayM]

American guys - has there been any news on 21st century cures act?

[nameless]

Shouldn't they technically not know if it works or not if this is a double blind study? Neither the subject or investigator should know if they received SM04554 or placebo until conclusion.

Of course practically speaking it should be obvious if patients are returning with cosmetically visible, to the plain eye changes in hair density.

I find it surprising that they would initiate a second Phase 2 without knowing even the possibility of success. However, they do seem to be money rich. They even have their own D.C. lobbyist. I am not sure if this is common for small biotechs or not.

Lobbyist Registration

I agree with you that technically they should not know for sure if the treatment works or not, but like you said it seems like they would be able to perceive if some patients are obviously growing hair. So yes, I do think that they probably know if their drug works or not. And *if* they do know that their drug does not work then it makes no sense at all that they would waste more money on the supplemental study that they just initiated.

[macbeth81]

I just tried to talk with Samumed. They're very paranoid and secretive. They won't even discuss the phase 2 that has almost completed. They did say that they do not know yet if SM04554 works or not.

Shouldn't they technically not know if it works or not if this is a double blind study? Neither the subject or investigator should know if they received SM04554 or placebo until conclusion.

Of course practically speaking it should be obvious if patients are returning with cosmetically visible, to the plain eye changes in hair density.

I find it surprising that they would initiate a second Phase 2 without knowing even the possibility of success. However, they do seem to be money rich. They even have their own D.C. lobbyist. I am not sure if this is common for small biotechs or not.

Lobbyist Registration

[lacazette]

I really believe in samumed, if it really works (like in studies with new HF formation from existing ones) even a high Norwoods will be able to undergo a big hairtransplant with a decent result
If Samumed give me my hair life back , I will tatoo them upon my heart hehe

I really hope they are planning the asian market already, and that this seconde phase 2 with biomarkers could be sufficient for a future release there (cause 'im afraid it can't be the case in US as the 21st cure bill will take months to become reality). i can't wait too long before testing this Wnt activation!

[JayM]

I just tried to talk with Samumed. They're very paranoid and secretive. They won't even discuss the phase 2 that has almost completed. They did say that they do not know yet if SM04554 works or not.

Tbf if they aren't going to say anything then they are probably going to say that aha.

[nameless]

@ nameless: Congress will be in November 18-21. (http://www.hair2015.org/)
Samumed is one of the most important sponsors (silver).
All of that can't be only pure coincidence in my opinion.

so the first phase 2 ends about 1 month before the 2015 congress. Interesting. They could have the phase 2 results by the time the 2015 congress begins. They will at least have some preliminary data. It seems to me that they should know if the drug works by then or not.

[Arieux]

@ nameless: Congress will be in November 18-21. (http://www.hair2015.org/)
Samumed is one of the most important sponsors (silver).
All of that can't be only pure coincidence in my opinion.

[nameless]

This is getting close to completion isn't it? I thought it was done by around November?

will be very interesting to see the results.

The study purportedly ends in October 2015.

What are the dates for the 2015 hair loss congress in Miami?

[nameless]

Hello all, new to the board here.

Start this trial today (USA). The doctor is extremely encouraged by the potential of this treatment, although the clinical research nurse with whom I spoke said she hasn't witnessed much growth in the patients she has seen thus far.

We shall see.

The study didn't even start until November 2014. Your first post is late January 2015. That means that your first post is 2 - 3 months after the study first started. I would not expect that a lot of patients would be seeing regrowth by the time you started.