And to be clear -- I cheer German Merck's advances in IVF therapies -- but I do wonder. . . how is it, exactly that making a vast German public pharma company. . . the beneficiary of a tens of BILLIONS of dollars in value FDA speed-voucher (assuming such an executive move is even lawful -- doesn't that power reside in the Congress?!) making "America Great, Again"?!
Yet again -- this is where we are: is Trump getting some form of under-the table pay-off, for directly slamming down his purportedly "Christian" hard right base -- a base that opposes a woman's right to use science to help her conceive?
I love that the Merck KGaA entity will soon win market clearance from FDA for its IVF therapy enhancers, but yikes. . . who is this feckless "Kennedy manipulated" geezer, now? And, just the latest -- from an inside-pharma trade rag:
. . .[M]ore fertility options for US patients are on the way. In conjunction with the MFN deal, Merck also announced that it's part of the inaugural cohort of companies to receive one of the FDA's new Commissioner’s National Priority Vouchers (CNPVs). The pharma plans to use its voucher to accelerate review of Pergoveris, an IVF therapy that combines recombinant human follicle-stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH) in a single injection pen. The product has been approved in Europe since 2017.
With the CNPV, Merck is promised a regulatory decision on Pergoveris within one to two months after filing the application, along with "enhanced" communication with FDA staff during the review process. . . .
It is not at all clear to me that FDA has the regulatory power (without Congress) to create "new kinds" of priority review vouchers. Damn. What a strange, strange. . . and likely. . . corrupt world this is, at the moment. Damn.
नमस्ते
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