Yep its interesting. The whole DMOAD thing seems to be about creating the link between clinical outcomes (pan, function) with structural measurable ones (biomarkers, imaging, etc..). No point having a BME shadow on an MRI disappear if the pain is still there. And likewise can't say something has changed the disease if it just masks the pain (eg opiods). That passage about talks about the "well-known structure sympton discordance". Feels like this bridge is the holy grail, and Im sure Mozz can help us decipher all of this.
I found this from looking further around which sums it up nicely...
https://www.fda.gov/media/71132/download
There should be substantial evidence that an effect on the candidate structural endpoint will reliably predict an effect on the clinical outcomes of interest which I think is a key to DMOAD.
Plenty in this tiny document and the last sentence is a cracker "Therefore, FDA welcomes efforts to address the above considerations and is open to work with all stakeholders on such programs".
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- Ann: PARADIGM RECEIVES FEEDBACK FROM US FDA ON IND SUBMISSION
Ann: PARADIGM RECEIVES FEEDBACK FROM US FDA ON IND SUBMISSION, page-164
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