Sm04554

[xyz123]

This is true. It is known that the 21st Century Cures act is supposed to add patient experience data as a valid metric for considering approval.

What I want to know is why they are doing it for SM04554. This tells me one of two things: The numerical data may be insufficient and they want to supplement it with patient data to ensure approval. Or that they may be able to get some sort of accelerated approval for SM04554 before or during Phase 3. Their Phase 2 had an unusually large number of patients. The 21st century cures act hints at accelerated approval without a phase 3, but mostly for treatments of life threatening diseases.

I really don't think they are missing their numbers. This second study with scalp biopsies has more ambitious endpoints than the first trial (and correct me if I'm wrong - but the hair growth questionnaire was filled out in the first trial - not the second? ).

These more ambitious endpoints are with just 50 patients - so ~ 17 in each group. They know how the drug is going to perform in this second Phase 2 based on the first Phase 2 - and I'm sure they based their sample size in the second study based on the results of the first. A smaller study indicates that they anticipate hitting these endpoints without needing as many participants - ie. the drug has a large effect size so fewer participants required to show statistical significance. If the drug didn't work, they would be setting themselves up for failure in the second Phase 2 study - and no company does that - they would either go back to the drawing board or move on.

Everything points to SM04554 being a success.

[JayM]

To be fair though it was a good spot with that they include patient experience data. It just adds to the fact this might be what they are after.

[nameless]

This is true. It is known that the 21st Century Cures act is supposed to add patient experience data as a valid metric for considering approval.

What I want to know is why they are doing it for SM04554. This tells me one of two things: The numerical data may be insufficient and they want to supplement it with patient data to ensure approval. Or that they may be able to get some sort of accelerated approval for SM04554 before or during Phase 3. Their Phase 2 had an unusually large number of patients. The 21st century cures act hints at accelerated approval without a phase 3, but mostly for treatments of life threatening diseases.

WTF?!?

The 21st Century Cures Act does not say "There should be an accelerated approval process but mostly for life-threatening treatments." What a joke! An act would never say something so vague is unspecific.

The 21st Century Cures Act allows for the elimination of phase 3 studies for almost all treatments.

[Justinian]

Could be to assist with FDA approval. The mental health issues surrounding hair loss are hardly known or understood by those who do not suffer hair loss.

This is true. It is known that the 21st Century Cures act is supposed to add patient experience data as a valid metric for considering approval.

What I want to know is why they are doing it for SM04554. This tells me one of two things: The numerical data may be insufficient and they want to supplement it with patient data to ensure approval. Or that they may be able to get some sort of accelerated approval for SM04554 before or during Phase 3. Their Phase 2 had an unusually large number of patients. The 21st century cures act hints at accelerated approval without a phase 3, but mostly for treatments of life threatening diseases.

[dus]

I was looking over the page on clinical trials concerning SM and saw that one of their secondary objectives is to have the patients fill out a document on how hair loss affects their life.
Is this normal for when they do hair loss trials?

Idk, but if its not normal, to me it sounds as if they are gathering more data that could be used to help promote the product. Which, isnt that something they might do if its nearing release?

"X amount of men say hair loss negatively affects their quality of life.....buy our product"

Could be to assist with FDA approval. The mental health issues surrounding hair loss are hardly known or understood by those who do not suffer hair loss.

[champpy]

I was looking over the page on clinical trials concerning SM and saw that one of their secondary objectives is to have the patients fill out a document on how hair loss affects their life.
Is this normal for when they do hair loss trials?

Idk, but if its not normal, to me it sounds as if they are gathering more data that could be used to help promote the product. Which, isnt that something they might do if its nearing release?

"X amount of men say hair loss negatively affects their quality of life.....buy our product"

[lacazette]

yeah sorry man :P i read it too speedly your right, we will be able to say goodbye of the old long phase 3 soon

"Alexander said his goal for the legislation “is to try to align federal policies in such a way that we’re able to move discoveries through the entire process of innovation, regulation and investment into the medicine cabinet more rapidly and at lower cost.”

But maybe samumed will do a normal phase 3, cause if the senate pass his own version in middle/ late 2016, then add the time for the laws to take place effectively, , it will take some time
samumed could already begin in late 2015 a big phase 3 for another year and then the 21st cure bill will at least accelerate the phase 4 fda approval

[It's2014ComeOnAlready]

Oh thnaks dude, my bad

So it sounds good:

"“I think it’s fair to say that I think this is a train that will actually get to the station,”

The chamber will pass its own version in 2016 (in the beginning I hope)

"We’re working on a similar bill on a parallel track — not the same bill, a similar bill.”
please don't scare me, they won't change the phase3/biomarkers thing right?

No, I doubt that is taken out. If you note from the article, it explicitly states that they're interested in getting meds in to the medicine cabinet more quickly, and at lower cost. You cannot avoid altering phase 3 studies if you want to do that, because that's the longest trial that costs the most money.

Also, it states that they are not interested in lowering safety standards, but rather adding and using more information. Biomarkers for phase 3's are use of more information imo.

LAST POST! lol enjoy the rest your summer, guys.

[lacazette]

Oh thnaks dude, my bad

So it sounds good:

"“I think it’s fair to say that I think this is a train that will actually get to the station,”

The chamber will pass its own version in 2016 (in the beginning I hope)

"We’re working on a similar bill on a parallel track — not the same bill, a similar bill.”
please don't scare me, they won't change the phase3/biomarkers thing right?

[It's2014ComeOnAlready]

So what's the news regarding 21st cure bill? when does the senate will vote, still an unknown date?

This act has to pass, like that even if Samumed have to do a phase 3, it will be a little one with multiple biomarkers instead or a large long one.

we need to activate our wnt pathway!!!

http://morningconsult.com/2015/07/the-senates-cures-bill-is-coming-next-year/

Last post! lol check the pdf I posted a page or so back, this is the same senator who is working on the bill, he definitely gets the idea.

[nameless]

So what's the news regarding 21st cure bill? when does the senate will vote, still an unknown date?

This act has to pass, like that even if Samumed have to do a phase 3, it will be a little one with multiple biomarkers instead or a large long one.

we need to activate our wnt pathway!!!

Posters need to contact their US senators and insist that the senators pass the bill in the same form that the house passed it.

[lacazette]

So what's the news regarding 21st cure bill? when does the senate will vote, still an unknown date?

This act has to pass, like that even if Samumed have to do a phase 3, it will be a little one with multiple biomarkers instead or a large long one.

we need to activate our wnt pathway!!!

[burtandernie]

Tell that to the clickbait journalists.

Yeah like the PGD 2 news. There were stories saying MPB will be cured in 2 years. Granted Seti might come out someday and we will see something from that, but its been more than 2 years already. I mean 2 years was a completely made up arbitrary number.

[JayM]

New trial? https://clinicaltrials.gov/ct2/show/...sm04554&rank=1

Just scroll back a few pages.

[GSD]

New trial? https://clinicaltrials.gov/ct2/show/...sm04554&rank=1