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Please review my letter to the FDA Biologics and Dr. Robert M. Califf in strong support of debamestrocel (“NurOwn”). regulations.gov/comment/FDA-20… Rep. Brett Guthrie Rep. Anna G. Eshoo  U.S. Senator Bill Cassidy, M.D. Markwayne Mullin Sen. Lisa Murkowski @SenatorBraun Rep. Jason Crow Ken Calvert Rep. Brian Fitzpatrick 🇺🇸 Rep. Terri A. Sewell Brian Wallach

"The fact that benefit was most notable in those early in their disease course is uniquely compelling rather than discouraging since earlier interventions have higher chances of modifying the disease course in many neurological diseases." #NurownIsSafe #NurownWorks

"FDA’s risk-benefit calculation in ALS must be different than it is for therapies developed for non-life-threatening conditions. There is almost no risk worse than imminent death from ALS." #NurownIsSafe #NurOwnWorks

"Debamestrocel also made a difference in the actual CSF biomarkers. This is big. This means that, unlike the placebo, it is actually changing the push and pull between the body and the disease and we are actually making progress against the disease itself." #NurOwnWorks

"Your decision has the power to rewrite the narrative for #ALS patients. Please let it be one of hope, compassion & a testament to the value of every human life." ~ 24 yr old's plea for #NurOwn regulations.gov/comment/FDA-20… FDA Biologics Dr. Robert M. Califf help him CDC Environment count him

"Why limit access to a potential therapy, even if it only benefits a subset of patients? Any therapy that can help a patient and their family slow down or reverse the progression of this disease should be left up to those affected by ALS." #NurownIsSafe #NurownWorks

"Making this product available to patients while validation of this retrospective analysis is carried out seems warranted. Our patients will be the ultimate beneficiaries." -Dr. Appel, one of the world's preeminent ALS researchers

WOW! Download & read this powerful statement by Patricia Manhardt in support of #NurOwn's approval. regulations.gov/comment/FDA-20… #NurOwnWorks #NurOwnPreservesFunction🛟 #ALSclock FDA Biologics Dr. Robert M. Califf Rep. Brad Wenstrup

In all due respect, it seems straightforward to approve #NurOwn, whose benefit to risk ratio is high. ~ Dr Marc Lenaerts, MD Vice Chair #Neurology at UC Davis with 30+ yrs experience #NurOwnWorks #NurOwnPreservesFunction🛟 #ALS #neurotwitter regulations.gov/comment/FDA-20… FDA Biologics

As a #neurologist with expertise in neurodegenerative diseases, having witnessed serial failures due to inabilities of therapies to cross the BBB, the impact that this successful therapeutic option (#NurOwn) has to halt the progression in #ALS is not one to be ignored. ~ William

"There is an unmet clinical need in ALS that by many measures exceeds that of many malignancies...the clinical data looks very promising, and exceeds the benchmarks which have led to the approval of many drugs in oncology." -Dr Koshkin, UCSF oncologist. PLEASE REPOST!!

Don't you DARE say you thought the patients' testimony was "compelling" or you are "sympathetic" or you "understand" their pain or that you were "moved" by them or "your heart bleeds." INCREMENTAL changes aren't enough? You don't get to decide what matters to patients when you

Media reporting on #NurOwn must read response to MedPage Neurology by Sean Mino, a Johns Hopkins trained anesthesiologist. Yes, subgroup of 27/48 score was not pre-specified, but for God's sake, people with #ALS are dying. Oncology regularly uses post hoc & CDER used post hoc or

ALS Uncensored 🏴‍☠️ The #NurOwn AdCom on Sept 27th was like: Russian trial of an American citizen... Then Pharma media was like Russian TV reporting on the Ukraine War. Pharma media has NOT done Due Diligence. They: 🔹Don't understand #ALS 🔹Don't understand flawed subjective tool used for