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Posted On: 06/03/2020 11:21:55 AM
Post# of 149527
If anybody is doubting (not saying anybody is) the accuracy of NP's interpretation and communication of the FDA's intent with regards to no longer issuing eINDs, I refer you to this quote from a company named Ansun, which has it's drug DAS181 in trial for Covid. Quote is from the CEO.
"Word has spread of the results in China as Lewis said Ansun has received some requests for compassionate use of DAS181, but he noted that the FDA “frowns upon” the use of the drug in that manner. He said even if the patients who use the drug under compassionate use get better, researchers no not learn much from the results."
In the eyes of the FDA, compassionate use and eIND's will slow trials and siphon patients away from the primary validation process the FDA relies upon to approve or disapprove a drug (RCT trials).
(https://www.biospace.com/article/ansun-biopharma-takes-aim-at-covid-19-with-experimental-influenza-treatment/)
"Word has spread of the results in China as Lewis said Ansun has received some requests for compassionate use of DAS181, but he noted that the FDA “frowns upon” the use of the drug in that manner. He said even if the patients who use the drug under compassionate use get better, researchers no not learn much from the results."
In the eyes of the FDA, compassionate use and eIND's will slow trials and siphon patients away from the primary validation process the FDA relies upon to approve or disapprove a drug (RCT trials).
(https://www.biospace.com/article/ansun-biopharma-takes-aim-at-covid-19-with-experimental-influenza-treatment/)
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