Baltimore, MD - May 17, 2022 - Rabbi Doniel Balsam, a well known member of our community has been diagnosed with ALS, also known as Lou Gehrig's disease. He is a member of Khal Ahavas Yisroel Tzemach Tzedek and his Rav, Rabbi Dovid Heber, recently sent out the following message to his kehila which we share with the entire community.

"As many of you know, our dear member Reb Doniel Balsam has been diagnosed with ALS, also known as Lou Gehrig's disease r”l. Please continue to daven on behalf of Doniel Yitzchak ben Devorah.

The following was brought to my attention:

AMX0035 is a drug that sounds promising in slowing the progression of ALS. However, it has not been approved yet by the FDA and is therefore not available to those suffering from this disease.

The ALS Association has informed us that the FDA is poised to make a decision regarding AMX0035 next month.

I have discussed this with doctors and I urge you to sign the following petition (linked below) to urge the FDA to approve AMX0035.

The following is the formal statement from the ALS Association with links to urge the FDA to approve it."

The FDA is poised to make its approval decision for AMX0035, a treatment that has been proven to slow the decline of function AND extend life for people with ALS, before the end of June. Unfortunately, approval is not guaranteed. Will you tell the FDA that people living with ALS deserve access to safe and effective treatments NOW?

For the last two years, people living with ALS, their families, and the Association have been doing everything possible to push for AMX0035 to be quickly available. We petitioned the FDA to act with urgency, we held a powerful action meeting where people with ALS shared their views on the desire to take AMX0035 with the FDA, and we urged the FDA Advisory Committee to recommend approving this new treatment.

People living with ALS CAN’T WAIT another year or two for results from the phase 3 clinical trial of AMX0035 to provide certainty.

Now is the time for the FDA to show their commitment to people with ALS, their families and caregivers.

Click here to join us in sending a clear message to the FDA that they must approve AMX0035.

Take Action

Note, even if you signed a similar petition previously (in September, 2020), it is important to also sign this petition which is different than the previous one.

 Thank you.