Here's how honest and aboveboard the FDA is. The c
Post# of 154635
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Posted On: 08/04/2023 10:22:06 AM
Here's how honest and aboveboard the FDA is. The company Mesoblast (ever hear of it? Me neither) has a drug that is effective against graft vs. host disease. But hey, if Big Pharma can't get a piece of the pie, why listen to the scientific advisors?
And now they want them to do yet another study. Who wants those pesky transplant patients to survive, anyway?
https://endpts.com/fda-hits-mesoblast-with-cr...cute-gvhd/
Quote:
The FDA’s first rejection came even after the Oncologic Drugs Advisory Committee gave a thumbs-up by a 9-1 vote that year. The committee was not concerned about the trial design and didn’t see the need for an additional study at the time.
And now they want them to do yet another study. Who wants those pesky transplant patients to survive, anyway?
Quote:
“FDA’s inspection of our manufacturing process resulted in no observed concerns, the Agency raised no safety issues across more than 1300 patients who have received remestemcel-L to date, and acknowledged improvements to our potency assay ,” Mesoblast CEO Silviu Itescu said in the statement.
https://endpts.com/fda-hits-mesoblast-with-cr...cute-gvhd/
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