It seems to me, reading the article, that the drug
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Posted On: 09/21/2023 12:48:59 AM
Re: craigakess #137342
Quote:
It seems to me, reading the article, that the drug company and the FDA had agreed on how a trial should go and the company hasn't done it yet.
Read it again.
Quote:
Reuters reports the FDA wants to see data from a repeat-dose study involving Neffy and a rival injected product before a potential approval rather than after, as the two sides had earlier agreed upon.
The FDA agreed to the trial as it was done and has now changed it's mind after a rival to the product objected. The FDA changing it's mind based on the data is one thing. Changing it's mind at the behest of a competing company is disgusting.
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EpiPen-maker Viatris had petitioned the FDA to require that ARS conduct additional trials "that closely mimic real-world conditions
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