Thank you, kevli!
That is a most comprehensive article. After reading about the complexities, indecisiveness, and nuances, which have lead to blind alleys and not so stellar progress in many areas, it is very good to know that we have a co-author, and widely published and cited authority on this subject on the field for us at this pertinent juncture.
Some very interesting points touched upon: had no idea “biomarkers” dated back to ancient times!
The description of the process of back and forth shows what we were probably up against for many months now and eventually led to a clearer path and the inclusion of the Regulatory Pathfinders LLC President on our team.
Interesting that some posters suggested that other companies have been able to get their trials approved under the state of flux the FDA is in. Very possible, probable!, that these companies have similar folks in house or used the same kind of expert to interface on their behalf...otherwise, there would be no market for Dr. Goodsaid’s work.
The FDA still has no clarity on the remedy for this problem and it is ongoing.
This is what led to a post about a week back where several of us discussed that absent something visible to measure, we were likely to continue to drift with no resolution.
Hopefully, the problem will be resolved in time to help regulatory agencies become more precise and streamlined. Sincerely glad we have F. Goodsaid with us now.
Thank you again for great research. Capital!!
“FDA, heal thyself!”
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