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Re: boi568 post# 275468

Tuesday, 10/13/2020 2:12:13 PM

Tuesday, October 13, 2020 2:12:13 PM

Post# of 462978

If the delay is unavoidable, no such inferences can be drawn and a full range of outcomes should be in play.


After viewing the fecklessness and ineptitude of multiple bureaucratic agencies during this China virus crisis, I opt for the “unavoidable delay” scenario as most likely.

The FDA + the EMA + the EMEA + TGA + (on and on) = = massive regulatory boon-doggle, with much time and effort and many lost lives.

The 800 lb gorilla in the room is the FDA (with 15K+ employees doing what(?)) and it’s regulatory equivalents, with their archaic/arcane rules, regulations and methodologies which have been derived from and stuck back in the 20th century - while with A2-73 we’re talking about innovative 21st century medical advancements - the two worlds don’t exist well together, as we’re seeing.

It certainly appears that the FDA (along with these other big fat bureaucratic agencies) need to be completely over-hauled and dragged, kicking and screaming, into the 21st century - then maybe innovative drugs, such as A2-73, would have a much better chance of seeing timely success.
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