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.

Wouldn’t It Be Nice If Our Honorable Members of Congress Would Add This In Their Next Address To Congress…

…I have asked my colleagues to join me in asking the president for an Executive Order to give full approval of NurOwn®. In the meantime, I will be sponsoring a bill to immediately change: “The Right To Try”; so that companies of all sizes can offer this alternative, while recouping all of their costs (including indirect ones).  I am also going to sponsor a bill to immediately change the regulations, allowing for accelerated approval, to remove any and all punishments if endpoints aren’t met (that allow more than just bio-markers), so that ALS will be included!

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”.

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.