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Posted On: 02/17/2023 9:58:19 AM
Post# of 148878
This in the NYTimes about flu/Covid drug. We need a BP partner, the ONLY way.
For all of its promise, though, the drug — called pegylated interferon lambda — faces an uncertain road to the commercial market. Regulators at the Food and Drug Administration late last year told the drug’s maker, Eiger Biopharmaceuticals, that they were not prepared to authorize it for emergency use. Eiger executives said part of the problem seemed to be that the clinical trial did not include an American site, but rather only sites in Brazil and Canada, and that it was initiated and run by academic researchers, rather than the company itself.
The regulators suggested that only a large clinical trial conducted at least in part in the United States and with more involvement from the company would suffice, Eiger executives said, a scenario that would require several years and considerably more funding. An F.D.A. spokeswoman said disclosure laws prevented the agency from commenting.
For all of its promise, though, the drug — called pegylated interferon lambda — faces an uncertain road to the commercial market. Regulators at the Food and Drug Administration late last year told the drug’s maker, Eiger Biopharmaceuticals, that they were not prepared to authorize it for emergency use. Eiger executives said part of the problem seemed to be that the clinical trial did not include an American site, but rather only sites in Brazil and Canada, and that it was initiated and run by academic researchers, rather than the company itself.
The regulators suggested that only a large clinical trial conducted at least in part in the United States and with more involvement from the company would suffice, Eiger executives said, a scenario that would require several years and considerably more funding. An F.D.A. spokeswoman said disclosure laws prevented the agency from commenting.
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