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Saturday, 05/02/2020 9:48:27 AM

Saturday, May 02, 2020 9:48:27 AM

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How will biotech be affected long term post pandemic? Will drug approval become more liberal? (Gileald’s drug, remdesivir I believe failed its endpoint —lowering deaths—in the study, and the FDA let them change the measure from lowering deaths to shortening hospital stays from an average of 15 to 11.) Will the FDA now apply that standard to other drug trials? If you rush drugs through to treat people for a virus, should you rush approval of drugs for people terminally ill from cancer, central nervous system diseases, etc.? Gilead’s drug received emergency approval. Will emergency approval be applied to terminally ill patients? Will it be applied to diseases that create financial burdens for individuals and governments?

Vaccines for the C-virus and possibly other drugs to treat the virus will be rushed to approval as well. Will governments, the FDA, politicians, and society simply accept that the drug approval process revert to what it was before the pandemic? Will governments and others be more forthcoming with funding of drug trials to treat other devastating diseases? Will this experience change drug approval for better or worse? Thoughts? Ideas?

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