Sm04554

[It's2014ComeOnAlready]

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

How it works is: once it goes through congress, it goes to the senate, once it goes through the senate, it goes to the President's desk. Once it's signed, it becomes law within 10 days, (or a very short time) I believe. The best part about all of this is that it has a lot of support by both democrats and republicans. It's very likely it will get to the President's desk, and he will probably be likely to sign it because for once in a long time, a bi-partisan bill has been presented by congress. Also, it improves upon changes he helped made through Obamacare.

The FDA also gets $550 million to make the necessary changes. But once it's signed into law, it's the law. It should benefit drugs going into trials after it is signed. From everything I've read, it seems that this bill should get to the President's desk before the end of the year.

[burtandernie]

Lets hope it doesnt jeopardize safety though by trying to speed the whole thing up. Your always trading safety for money/time because those big double blind studies arent cheap and fast to do.

[It's2014ComeOnAlready]

Lets hope it doesnt jeopardize safety though by trying to speed the whole thing up. Your always trading safety for money/time because those big double blind studies arent cheap and fast to do.

I agree, but when it comes to a drug like Seti, which has been proven safe through thousands of participants, I do not care. Release it tomorrow.

[lacazette]

How it works is: once it goes through congress, it goes to the senate, once it goes through the senate, it goes to the President's desk. Once it's signed, it becomes law within 10 days, (or a very short time) I believe. The best part about all of this is that it has a lot of support by both democrats and republicans. It's very likely it will get to the President's desk, and he will probably be likely to sign it because for once in a long time, a bi-partisan bill has been presented by congress. Also, it improves upon changes he helped made through Obamacare.

The FDA also gets $550 million to make the necessary changes. But once it's signed into law, it's the law. It should benefit drugs going into trials after it is signed. From everything I've read, it seems that this bill should get to the President's desk before the end of the year.

Thanks a lot dude for all these informations, it gives me hope and the smile

This bill will help us to have new treaments sooner than expected. And it's a Fu..... great new as I am nw4 at 27!

I also have hope on stem cell treatments and regenerative medecine in japan in 3-4 years. I want to believe it, I need to believe it ^^ I don't want the "in 5 years'' thing come back again and again, please God! lol

[nameless]

Does anyone else agree with my point that *if* anti-androgens regrow hair upstream from Wnt stimulation then that means that SM05445 would have to be applied permanently the same as anti-androgens have to be applied (or swallowed) permanently.

I mean, if anti-androgen efficacy is on the same stream as Wnt efficacy then that means that if one has to be applied permanently then the other would have to be applied permanently also, right?

And if anti-androgens work via the same pathway as Wnt simulation then that means that SM05445 might be an effective treatment if it's applied permanently but they might not figure that out if they cease treatment after a few months. It might take 4 - 6 months for improvement to be visible and if they only apply it 3 months then they wouldn't even see the improvement that would have happened if they kept applying it another month. Right?

[TooMuchHairWontKillYou]

Does anyone else agree with my point that *if* anti-androgens regrow hair upstream from Wnt stimulation then that means that SM05445 would have to be applied permanently the same as anti-androgens have to be applied (or swallowed) permanently.

I mean, if anti-androgen efficacy is on the same stream as Wnt efficacy then that means that if one has to be applied permanently then the other would have to be applied permanently also, right?

And if anti-androgens work via the same pathway as Wnt simulation then that means that SM05445 might be an effective treatment if it's applied permanently but they might not figure that out if they cease treatment after a few months. It might take 4 - 6 months for improvement to be visible and if they only apply it 3 months then they wouldn't even see the improvement that would have happened if they kept applying it another month. Right?

calm down they know their job

[burtandernie]

All these questions will be answered as they develop it. Patience. I dont see anything new that is not a constant treatment like propecia that you have to use everyday.

[It's2014ComeOnAlready]

Proposed legislation from the 21st Century Cures Act:

"The initiative's proposals could help to revolutionize the current drug approval process. Today, pharmaceutical companies test thousands of compounds in the lab until they identify one that shows promising medical applications. Next, they conduct "phase I" trials on healthy adult males to ensure a drug is safe. Phase II trials provide an initial assessment of a drug's effectiveness in sick patients. Phase III, which involves thousands of volunteer patients, helps confirm the results of phase II trials.

The draft legislation will allow FDA regulators to approve a groundbreaking drug if it proves effective after a phase II trial. That will deliver treatments to patients much sooner and eliminate the need for some phase III trials, which take years and account for 90 percent of the total development costs for drugs that eventually gain FDA approval.

The 21st Century Cures Initiative will also spur new drug development by helping biotech companies "fail faster." Of all the potential medicines that enter phase I trials, only 8 percent ever receive FDA approval. The proposed legislation would expedite "adaptive clinical trials" which identify the failures -- the other 92 percent -- earlier. That prevents researchers from wasting time and money on drugs that ultimately don't pan out.

Identifying and scrapping those failures earlier in the research and development process will allow drug companies to redirect billions towards more promising treatments. If adaptive clinical trials can catch even 5 percent of eventual failures in phase I instead of phase III, pharmaceutical manufacturers will save at least $15 million per drug.

The proposed changes mark the beginning of a transition towards a true 21st century innovation system that eliminates traditional phase II and III trials altogether. In such a system, doctors, insurers, and drug makers could use the power of big data to chart a drug's effectiveness and patient outcomes as soon as it proves safe in phase I trials. Using crowd-sourced, real world data will deliver lifesaving treatments to patients years quicker than the current clinical trial process."

[FearTheLoss]

Proposed legislation from the 21st Century Cures Act:

"The initiative's proposals could help to revolutionize the current drug approval process. Today, pharmaceutical companies test thousands of compounds in the lab until they identify one that shows promising medical applications. Next, they conduct "phase I" trials on healthy adult males to ensure a drug is safe. Phase II trials provide an initial assessment of a drug's effectiveness in sick patients. Phase III, which involves thousands of volunteer patients, helps confirm the results of phase II trials.

The draft legislation will allow FDA regulators to approve a groundbreaking drug if it proves effective after a phase II trial. That will deliver treatments to patients much sooner and eliminate the need for some phase III trials, which take years and account for 90 percent of the total development costs for drugs that eventually gain FDA approval.

The 21st Century Cures Initiative will also spur new drug development by helping biotech companies "fail faster." Of all the potential medicines that enter phase I trials, only 8 percent ever receive FDA approval. The proposed legislation would expedite "adaptive clinical trials" which identify the failures -- the other 92 percent -- earlier. That prevents researchers from wasting time and money on drugs that ultimately don't pan out.

Identifying and scrapping those failures earlier in the research and development process will allow drug companies to redirect billions towards more promising treatments. If adaptive clinical trials can catch even 5 percent of eventual failures in phase I instead of phase III, pharmaceutical manufacturers will save at least $15 million per drug.

The proposed changes mark the beginning of a transition towards a true 21st century innovation system that eliminates traditional phase II and III trials altogether. In such a system, doctors, insurers, and drug makers could use the power of big data to chart a drug's effectiveness and patient outcomes as soon as it proves safe in phase I trials. Using crowd-sourced, real world data will deliver lifesaving treatments to patients years quicker than the current clinical trial process."

WOW....this is huge. This means CB could be out by 2018, and seti could be out within a year and a half and bim could be out right away if it applies.

[It's2014ComeOnAlready]

WOW....this is huge. This means CB could be out by 2018, and seti could be out within a year and a half and bim could be out right away if it applies.

SM, too, if it succeeds in phase 2.

[FearTheLoss]

I wonder if this would apply to histogen hsc too?

[FearTheLoss]

If this gets passed into law and sm is successful it could be out this time next year

[FearTheLoss]

Actually, unfortunately, it seems this would only apply to life threatening illness, or more serious matters than hair loss. It doesn't eliminate a phase 3 for most

[It's2014ComeOnAlready]

If this gets passed into law and sm is successful it could be out this time next year

I really, really, really think this bill will pass. It has a lot of bi-partisan support AND is expected to get over 350 votes in congress (80%). Once it gets to the senate (which is also mostly republican), it should get the votes as well to get to Obama's desk. He spoke in his last State of the Union about "precision medicine." This bill tackles that to a degree, and helps build upon improvements made in healthcare by Obamacare. Also, it's bi-partisan, and started in congress. Barely anything has come out of congress in a really, long time.

Also, the bill is expected to be signed into law before the year is out.

[It's2014ComeOnAlready]

Actually, unfortunately, it seems this would only apply to life threatening illness, or more serious matters than hair loss. It doesn't eliminate a phase 3 for most

Where does it say that? Everything I've read has this law applying to clinical trials in general, not especially for life-threatening illnesses only.