The Food and Drug Administration on Thursday approved an experimental treatment for A.L.S., a severe neurological disorder that causes paralysis and death, despite questions about the therapy’s effectiveness, DNYZ reports.
The treatment, conceived about a decade ago by two college students, was approved even though analyses by the F.D.A.’s reviewers concluded there was not yet sufficient evidence that the medication could help patients live longer or slow the rate at which they lose functions like muscle control, speaking or breathing without assistance. Nevertheless, the agency decided to greenlight the drug without waiting two years for results of a large clinical trial, citing data showing the treatment to be safe and the desperation of patients with a disease that often causes death within two-to-five years.
The drug, which has the scientific name AMX0035, will be marketed as Relyvrio.
In a summary memorandum about the drug the F.D.A. wrote that there was “residual uncertainty about the evidence of effectiveness,” but that “given the serious and life-threatening nature of A.L.S. and the substantial unmet need, this level of uncertainty is acceptable in this instance.” The memorandum also said that the benefits outweigh the risks because the treatment is “without any significant safety signals of concern.”
The FDA can never be trusted, even to tell you what time it is.
Tell this to the sleeping sheeple who’d trust the FDA, the CDC, Big Pharma, all doctors and nurses blindly even to continue with more and more shots.
“F.D.A. Approves A.L.S. Treatment Despite Questions About Effectiveness” Haven’t we heard the same words regarding the death jabs from the FDA? Keep away from this criminal Deep Organization.
On the other side, if you agree with this statement “given the serious and life-threatening nature of A.L.S. and the substantial unmet need, this level of uncertainty is acceptable in this instance.” then the headline is sort of “fake news”. This obviously is the right decision.
But yet sheeple like you were all sanctimoniously “concerned” that smart educated people were willing to take Ivermectin in order to save their lives after contracting Covid 19, before vaccines were ready.
Please stop the foolish moronic comments. If you knew someone with ALS you would be very happy that they approved it. What exactly is the downside here? Even if there is some chance it work I cant imagine any scenario why someone in that state wouldn’t try it.
You’re right and so are the commentators because the FDA has been proven to a dangerous organization (with millions of deaths and injured). If they approve something it should be well researched.