I believe we all received via email a link to yesterday’s meeting. Thank You Wayne for providing the link. For me it was time well spent. I did not know that the FDA had, in 2020 I believe, created a Division of Hepatology. The meeting provided the opportunity for several NASH patients, and patient advocate leaders to speak directly to the FDA, including the new Division of Hepatology Director. Wayne spoke of the need for the FDA to do all they could to expedite the clinical trial process while still proceeding carefully. He also spoke about liver biopsy, and while still useful in some cases, advances have been made in testing which would diminish the need for those participating in clinical trials to have a biopsy as a requirement for participation. Also, we are aware of the problem with a liver biopsy being a hit or miss situation. Wayne also stressed we are collectively on the brink of a breakthrough which would result in the first ever FDA approved mediation. Hopefully this meeting yesterday is just the beginning of a dialogue and an ongoing conversation between the FDA, patient advocates, and patients. I believe members who view the meeting will also agree it was time well spent.
Best Wishes to All,
Troutwhisperer