“The order Section 4 states the FDA Director may
Post# of 148169
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Posted On: 12/05/2020 12:51:16 AM
“The order Section 4 states the FDA Director may accept the decisions of internationally recognized regulatory agencies when evaluating applications for EUA... that sounds like a road block for CYDY.
IMO, this isn’t a roadblock. The Philippines’ FDA is basically stating that they may approve drugs immediately that have already been approved by the FDAs of other countries. That would expedite the drug in question getting to Filipinos. In the case of leronlimab, CYDY might file for an EUA in the U.S., Phillippines and other countries at the same time, so section 4 above likely won’t be an option.
IMO, this isn’t a roadblock. The Philippines’ FDA is basically stating that they may approve drugs immediately that have already been approved by the FDAs of other countries. That would expedite the drug in question getting to Filipinos. In the case of leronlimab, CYDY might file for an EUA in the U.S., Phillippines and other countries at the same time, so section 4 above likely won’t be an option.
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