BLT 0.00% 2.6¢ benitec biopharma limited

time for a reality check, page-45

  1. 2,326 Posts.
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    Slightly OT, will be interesting to see if Tekmira's TKM-Ebola does the job and cures someone. Apparently only Z-Mapp and TKM-Ebola have been permitted by the FDA. (below from Wikipedia), so the world might soon find out if RNAi has saved the day!! And possibly humanity, for what it's worth.


    In the US, the FDA's Animal Efficacy Rule can be used, often in combination with a Phase I clinical trial, to demonstrate reasonable safety for a drug, to obtain permission to treat urgently sick people with the drug under the FDA's Expanded access program. The Animal Efficacy Rule exists because the normal path for testing the safety and efficacy of drugs is not possible for diseases caused by dangerous pathogens or toxins.[12][13] The FDA has allowed two drugs, ZMapp and an RNA interference drug called "TKM-Ebola", to be used in people infected with Ebola under these programs.[14]
 
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