Tuesday, October 27, 2020 7:30:10 PM
There are some confusing terms in the FDA, so let's clear that up first:
EUA - Emergency Use Authorization - this is what we're currently waiting on the fda to approve for us.
EAP - Expanded Access Protocol – currently approved and allows us to use the drug at clinical trial hospitals only on patients who are too sick to get into the trials.
FTD - Fast Track Designation - we already have this and it recently was "just granted" in June... this basically gives us more access to the FDA in terms of meetings and such.
So... we already have FTD (fda meetings) and EAP (treat sick patients at CT locations only)... but this EAP is too limited because it only helps a very small number of patients, so we're waiting on EUA (so we can use the drug at every hospital in the U.S.).
Now... if you (or maybe others reading this) didn't know all the differences with the above terminology, then I would suggest neither does the NYPost... what they seem to have done is mix the terms...
They took:
"Fast Track Designation" --and-- "Emergency Use Authorization"
and came up with a new term:
"fast-track emergency use designation"
(no such thing)
And when you combine that NYPost mistake with the other posting mistakes from this morning, it looks like they're all related. But in this case, I think NYP is a separate mistake. I could certainly be wrong... where there's smoke, there's fire... and today there seemed to be quite a bit smoke. I just don't know if NYP had anything to do with it.
Here's the Fast Track from June...
https://relieftherapeutics.com/newsblog/32-neurorx-and-relief-therapeutics-announce-fast-track-designation-granted-by-the-fda-to-rlf-100-aviptadil-for-the-treatment-of-respiratory-distress-in-covid-19
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