WASHINGTON (AP) — Drugmaker Sarepta Therapeutics (SRPT) said late Friday it won't comply with a request from the Food and Drug Administration to halt all shipments of its gene therapy following the death of a third patient receiving one of its treatments for muscular dystrophy.
The highly unusual move is a latest in a string of events that have hammered the company's stock for weeks and recently forced it to lay off 500 employees. The company's decision not to comply with the FDA also places future availability of its leading therapy, called Elevidys, in doubt.
There is not a single Doctor, (with a working brain) who is going to take the risk of using this gene therapy on a patient going forward. It's a sure lawsuit in the making and possible loss of license. IMO
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