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Thursday, May 28, 2015 10:47:39 AM
FDA Advanced Approval in 6 weeks, After 24 Week Global Tests Start (30 sites, Imetelstat)
"Patient benefits are typically apparent by the third dosage (six weeks after first treatment). Patients showing complete remission have shown reversal of fibrosis and even complete molecular response an astounding feat for a drug with patients who had been faced with near term death after other treatment failures."
JNJ/Janssen will be transparent about the progress of the new global, international trials. The FDA, while still one of the most important approval agencies, there are similar agencies in most countries. The FDA may not be the first to grant advanced IMET approval for the treatment of a basket of blood cancers (MF, MDS, AML).
"evil flourishes when good people fail to act"
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