'This is a victory for the entire ALS community...'
"This is a victory for the entire ALS community, which came together to advocate for early approval of AMX0035," ALS Association president and CEO Calaneet Balas said in the statement. "We still have a lot of work to do to cure ALS, but this new treatment is a significant step in that fight."who believe the eight years between the fundraising sensation and the drug's approval is rushed.
"I totally understand why people would be trying to figure out a way to get this to patients," Dr. David Rind, the chief medical officer of the Institute for Clinical and Economic Review nonprofit, toldWhat's more, its manufacturer admitted after its approval that it will, and that it's expected to only extend the lives of ALS patients by about six months.
The FDA said in its vote to approve Relyvrio that it was important to get it out quickly, rather than wait until the projected end date of another study in 2024.the agency wrote in a benefits-risk assessmentIn other words, there's lots of unprecedented stuff going on in with the approval of AMXo035, and only time will tell whether it earns its hype.
If nothing else, it provides patients suffering from one of the most grueling degenerative diseases a sliver of hope — and the comfort of knowing that millions of people cared enough about them to give money and dump ice on their heads to benefit their cause.
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