With regards to not running/including the labs...
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Posted On: 08/12/2020 11:10:15 AM
With regards to not running/including the labs...
If you listen to the question at ~19 min
https://www.youtube.com/watch?v=horRSvu6xAk
Dr. Yo Asks
Dr. Patterson Responds
In other words, I think he *wishes* the FDA would look at the world through his lens (the cellular level data) but he believes what the FDA cares about is what was in the press release (i.e. p values and the like). In other words, including the data would be unfortunately pointless as far as the FDA is concerned.
I think we are in agreement however that this data does bolster the narrative from a science standpoint. I wholeheartedly bought into the argument that beautiful medicine comes from correlating clinical performance of a drug with cellular metrics.
My hope is that the data that was in fact collected will be shared in the publication that NP said would follow soon after the results were made public and/or with the Big Pharmas that we were supposedly going to be sending our results to.
If you listen to the question at ~19 min
https://www.youtube.com/watch?v=horRSvu6xAk
Dr. Yo Asks
Quote:
Do these immunological data these viral loads...what you've been seeing in the last two or three months...would that data be presented to the fda? How does that work?
Dr. Patterson Responds
Quote:
Again...I think a lot of the EIND data...a lot of the scientific data...a lot of the studies we have been doing at the cellular level...that's not the type of data that the fda analyzes...the type of data that they analyze...the type of data that came out in the press release right...they have their statistical program and you know the fda is very much uh statistically based and um you know they probably don't have time to you know go over all the basic science studies
In other words, I think he *wishes* the FDA would look at the world through his lens (the cellular level data) but he believes what the FDA cares about is what was in the press release (i.e. p values and the like). In other words, including the data would be unfortunately pointless as far as the FDA is concerned.
I think we are in agreement however that this data does bolster the narrative from a science standpoint. I wholeheartedly bought into the argument that beautiful medicine comes from correlating clinical performance of a drug with cellular metrics.
My hope is that the data that was in fact collected will be shared in the publication that NP said would follow soon after the results were made public and/or with the Big Pharmas that we were supposedly going to be sending our results to.
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