Tpoxx, also known as tecovirimat and ST-246, was developed under the FDA’s streamlined “animal rule,” which was created to address potential terrorist threats after the 9/11 attacks. The rule allows testing on animals to determine efficacy and human clinical trials to determine safety and confirm dosage levels.

Now, because there is still no approved treatment for smallpox, Siga is seeking expedited FDA review of its new drug application. The company claims there were no drug-related serious adverse events during human testing.

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