1. Pink Sheet

How Not To Develop A Drug

 
• By Michael McCaughan

What is the best way to encourage drug development in an unmet medical need? Chronic Fatigue Syndrome advocates argue that FDA should approve a drug—specifically Ampligen—even if it falls far short of reaching typical standards of evidence. FDA disagrees, and gained the backing of its advisory committee on that point. But the vote was close…

It is hard to describe the Arthritis Advisory Committee’s December 20 rejection of Hemispherx Biopharma Inc.‘s Ampligen for Chronic Fatigue Syndrome as in any way surprising.

After all, this is an application with a remarkable track record of rejection at the Food & Drug Administration. The long regulatory history includes a Treatment IND that has been...

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