Sky is the limit As per the company Tesamorelin has IP for NAFLD/NASH in the US and Europe and company may expand the IP to other jurisdictions, the PDC th19 series have broad global IP coverage so they can potentially benefit from MRCT programs most likely with a partnership for either of their programs.
“With the increasing globalization of drug development, it has become essential that data from multi-regional clinical trials (MRCTs) is accepted by regulatory authorities across regions and countries as the primary source of evidence, to support and facilitate efficient marketing approval of drugs, said Allen Baharaff, Chief Executive Officer of Galmed.
Nonalcoholic fatty liver disease (NAFLD), a precursor of NASH, has an estimated prevalence rate in China that is expected to increase from 15%-20% in 2018 to 25%-30% in 2033, driven by increasing prevalence of obesity and type 2 diabetes.
The approval of the IND application of the ARMOR Study in China is a significant milestone in the development of Aramchol for NASH patients," said Prof. Junqi Niu”
https://www.prnewswire.com/il/news-releases/galmed-announces-approval-of-ind-application-in-china-for-aramchol-for-the-treatment-of-nash-amp-fibrosis-in-the-global-phase-3-armor-registrational-study-838718029.html