By rule, then FDA should announce its approval/non-approval decision -- on or before March 26, 2024 (though in such cases, it is nearly a 95 per cent probability -- for approval).
Once again, this show-cases Rahway's savvy as a deal doing pharma concern. Well played -- and here is the latest, from Reuters:
. . .Merck's application is based on data from a late-stage study in which sotatercept, combined with a background therapy, helped patients with pulmonary arterial hypertension (PAH) to walk about 40.8 meters more in six minutes. . . .
Sotatercept could also be the first treatment of its class, which targets a type of protein called activins that lead to higher levels of follicle-stimulating hormone associated with the disease.
J.P. Morgan analyst Chris Schott had estimated the therapy to reach peak sales of $3 billion to $4 billion.
Merck had said it expects PAH to be a roughly $7.5 billion market by 2026 when it announced the Acceleron deal. . . .
Now you know -- but no order from the Supremes yet -- on the Doughty mess out of Monroe, Louisiana to the Fifth Circuit. For its part (and perhaps belatedly seeing the error of their ways), the Fifth entered an order staying all of Doughty's July 4 ruling until further order. So, maybe the Supremes will rely on that, and not enter a formal extension of their own stay. We shall see. Onward.
नमस्ते
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