Friday, January 27, 2023

Dramatic letter from Esteban Bulrich to Joe Biden for the United States to approve a drug against ALS

The former senator called on the FDA to exercise “the broadest regulatory flexibility” with regard to a stem cell treatment called NurOwn for his disease.

esteban bulrich sent him one Carta and Joe Biden Asking for approval from the President of the United States and the US Food and Drug Administration (FDA) a Amyotrophic Lateral Sclerosis (ALS) Treatment,

Former MLA sent letter 500 patients signed with the disease he is also suffering from And asked that the powerful drug control body act with “wide flexibility” to give the green light to the treatment, which is, according to the description, “therapy with mesenchymal stem cells”.

“I want to let you know that we are going to be sending a letter to the President of the United States, the Director of the FDA, the Chairmen of the Senate Health Committee and the National Health Service requesting their approval. NooronBulrich wrote on his Twitter account.

“It’s a treat that even Demonstrated in trials that it can reverse the effects of disease, The letter has been signed by some 500 ALS patients in Argentina, but to increase the impact we want to add patients from across the region,” said the former national education minister, who revealed in April 2021 that he was suffering from ALS.




Esteban Bulrich, after being discharged for pneumonia.

Bulrich was diagnosed after studies and consultations with experts in Argentina and the United States noted speech problems. He made his illness public in late April 2021, and in December of that year he resigned his seat in the upper house amid a strong speech and applause from all senators.

On 21 September, the leader of the Juntos por el Cambio was discharged after spending three weeks in hospital in Australia, where he had been admitted due to pneumonia.

A month earlier he was present at a concert by the group Coldplay at River Stadium.

What the letter Esteban Bulrich will send to Joe Biden says

At the beginning of the letter, Stephen Bulrich described it as “immediate”. FDA required to give green light to mesenchymal stem cell therapy, NurOwn.

“It is my honor to address you On behalf of over 1,500 ALS patientsand their families and loved ones in Latin America who need your assistance with an urgent matter related to FDA approval mesenchymal stem cell therapy It’s called NurOne,” Bulrich said.

After reviewing and noting the features of the disease “there is no cure”showed him “Disappointment” By 6-4 vote against approval of AMX0035, a drug to slow the progression of ALS. This treatment was approved by Canada and the former senator himself requested it before the ANMAT last June.

,I’ve seen enough faces of despair and sadness in my family and friends to know that no one may live to see the ALS patient die slowly but steadily“, Bulrich added with the obvious play, for whom FDA approval would have been a strong signal to the rest of the country.

He then added that he understands the complex web of research and approvals that companies and the FDA go through before giving their approval for a treatment.

“But Mr. President, I think I speak for the majority of ALS patients when I say that we will happily waive any claims to gain access to a medicine that could potentially cure us,” Bulrich said,

And it was again hard and concrete: this is what you have to understand, Today our best scenario is a few more months, We are willing to experiment for ourselves, but also for our family and friends.”

“We expect the FDA to operate with broad regulatory flexibility. We expect the FDA to do so.” Hear from the best scientific mindsThe former Mauricio Macri government official insisted before saying goodbye to Biden.

NurOwn, developed by BrainStorm Cell Therapeutics, is a bone marrow stem cell therapy. According to a publication of the Argentine ELA Association, treatment did not reach statistically significant results and did not pass the Phase 3 study in November 2020.

Although this achieved a 35% response in treated patients, they were not significantly higher than the placebo sample’s record (28%).

Last August, the BrainStorm company announced that it had reviewed the studies and would submit a “biologics license application to the FDA.”

DS

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