Dr. Harrison on FDA/EMA This is a recent webinar from a small biotech in Israel with some comments from Dr. Harrison, it is interesting they are talking about using non-invasive tests for the trial’s proof of concept.
Dr. Harrison also mentioned that both FDA and EMA have given similar criteria for their approval policies.
“We see via its mechanism of action (MOA) and preclinical models, as well as the positive impact across a broad range of non-invasive tests from the proof-of-concept Phase IIa trial that this drug candidate has the potential to have a significant impact on fatty liver disease.”
“He commented that the U.S. Food and Drug Administration and the European Medicines Agency have given clear criteria for accelerated or conditional approval of a drug which can show either: NASH resolution without worsening of fibrosis, or fibrosis improvement without worsening of NASH.”
https://www.businesswire.com/news/home/20210128005575/en/Can-Fite’s-NASH-Indication-Highlighted-in-Webinar-by-KOL-Dr.-Harrison-“Namodenoson-May-Have-Big-Impact-on-NASH”