Our Dear Friends in Congress – Please Listen To Our Plea

 Life expectancy for an ALS sufferer is short – just 2-4 years.

In Summary: There is NO other drug in the current ALS FDA trial pipeline that will arrive in time to save the 94% of ALS sufferers who are alive today. If we don’t get NurOwn® on a viable pathway for early FDA approval soon, THOUSANDS MORE Americans will die. 

On Sept. 19th, 2019 Congressman Antonio Delgado spoke on the floor to lift the voice of a #NY19 resident Dan Shultes, 1 of the 30,000 Americans suffering from ALS.  He stated: “Congress must provide robust funding for disease research and create pathways for treatments that could improve the quality of life for those living with ALS”.

Now we must identify other members of  congress who are willing to join our voice. Our goal is to get an executive order created and signed that gives full approval for NurOwn® therapy.

 

Dan is one of 30,000 American’s suffering from ALS. We must act now. Time is not on our side. We need your help to get the FDA approve life-saving treatments.

Newly Introduced Bills

Please help support these Acts so that they may become law.

H.R.5497 – Conditional Approval Act

DOWNLOAD H.R.5497

and companion bill

S.3133 – Conditional Approval Act

DOWNLOAD S.3133

(Please remember to look in your downloads folder for the selected pdf).

These both address the need to  amend the Federal Food, Drug, and Cosmetic Act to establish a time-limited conditional approval pathway, subject to specific obligations, for certain drugs, and for other purposes.

Thanks to Mr. Westerman (for himself, Mr. Gallagher, and Mr. Burchett) who introduced the following bill; which was referred to the Committee on Energy and Commerce.

 

H.R.5480 – ALS Placebo No More Act

DOWNLOAD H.R.5480

(Please remember to look in your downloads folder for the selected pdf).

This Bill is to ensure that ALS patients have access to treatment within clinical trials.

Thanks to Mr. Fortenberry who introduced the following bill; which was referred to the Committee on Energy and Commerce.

Please Join The ALS Caucus Today

The ALS Caucus is co-chaired by Reps. Crow (D-CO), Fitzpatrick (R-PA), Sewell (D-AL), and Calvert (R-CA) and serves as a way to bring together Members of Congress from both sides of the aisle to share experiences, exchange ideas, and work collaboratively to find cures and accelerate treatments for ALS.  If you have questions, need more information about the caucus, and to join as a member of the ALS Caucus, please email Santiago.gonzalez@mail.house.gov.  

Please contact any of the co-chairs for the ALS Caucus:

Rep. Brian Fitzpatrick (R-PA) – Joseph Knowles Joseph.Knowles@mail.house.gov
Rep. Jason Crow (D-CO) – Santiago Gonzalez Santiago.Gonzalez@mail.house.gov
Rep. Terri Sewell (D-AL) – Hillary Beard Hillary.Beard@mail.house.gov
Rep. Ken Calvert (R-CA) – Joe Fuentes Joe.Fuentes@mail.house.gov

So far 97 members have joined.

Thanks to our friends at https://iamals.org for helping make this possible.

Currently, there are no clinically meaningful treatments approved by the FDA, that can reverse or stop the symptoms of ALS. Many ALS sufferers take a selection of pharmaceuticals, vitamins, minerals and herbal supplements to help control spasticity and some of the other ghastly symptoms of this terrifying disease.
There are some revolutionary, yet promising stem-cell treatments out there. However, they are still in the drug testing phase. One of those therapies is NurOwn®. It is being developed by Brainstorm Cell Therapeutics Inc.
We need to support BrainStorm, so that they may get approval from the FDA. We appreciate your help, compassion and support.

“One of our important goals is to get an executive order signed, that will allow full approval of NurOwn®, a highly promising stem cell therapy developed by Brainstorm Cell Therapeutics”.

FAST TRACK

We Need Your Help Today. We Cannot Wait.

Our urgent issue requires resolving the current FDA system, that addresses Drug development.

There is no system in place to address the urgent medical need of an always fatal disease like ALS.

There are some revolutionary, yet promising stem-cell treatments out there. However, they are still in the drug testing phase. One of those therapies is NurOwn®. It is being developed by BrainStorm Cell Therapeutics.

This gained Fast track approval in 2014. It is now in the middle of an archaic Phase 3 trial for 200 patients that is placebo-controlled. 100 patients are made to undergo a procedure called a bone marrow transplant, 7 lumbar punctures and 14 trips for the study to receive a placebo while dying from ALS.

This is simply inhumane.

This is the 4th trial for this therapy and it is showing promising results.  The FDA has been asked to use accelerated approval to approve it immediately. We also requested an interim analysis of the current phase 3 trial.  They stated that BrainStorm must request the analysis and take a penalty if it is not successful. This could jeopardize the whole trial.

The FDA has been asked to consider expediting the current trial process. Thus far, all have been denied. We need to raise awareness in DC about this horrible disease and why we need real therapies that can help us now.

We know that a US Senator cannot do either of the following:

  1. Intervene in an ongoing US FDA trial. OR
  2. “Force” a private company to do anything, but especially something that causes it to lose money – like force it to give NurOwn® under “right to try.”

However the solution is clear:

The FDA has no way to offer NurOwn® a way to halt its Phase 3 trial without risk or to submit its data NOW because this rule simply doesn’t exist. It’s currently “all or nothing”. We NEED AN EXECUTIVE ORDER.

The National Kidney Foundation recently got an executive order signed, so can we.

Please – we need to get an executive order for the FULL approval of NurOwn®. We ask that senators talk to the president about our plight.

Thank you for your valuable efforts. Time is not on our side, we need your help today.