Hi VFM,
Interesting question and, with the benefit of hindsight, one the more obvious questions to ask. As you say,if it were approved in Japan, MSB's short term financial health would improve. I think it would do better than that, as the target population for heart disease is much larger than that of aGVHD.
I've been wondering about your question since your post, but am no closer to understanding why they haven't gone down this path.I do have some of my views on this though.
While it's possible that MSB have completely missed what is staring at them in the face, I think it is highly improbable that this is the case. Especially given the fact that they already have a product being sold in Japan.
Could it be that they don't think they will be able to obtain approval for it's use in Japan? A brief look at the approval framework in Japan seems to indicate otherwise. I have no background in medical product approval frameworks or processes, so it's entirely possible that I have this wrong.
(BTW, for anyone interested in a very brief, high level overview of Japan's approval framework, I found this article, https://www.cell.com/cell-stem-cell/fulltext/S1934-5909(20)30449-5, a good starting point.)
Or, could it be that partnerships are difficult? Other than the generic, "partnership with Japanese companies are complex and challenging", statements, nothing I've read so far gives me a clear cut answer. I did come across this interesting article, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9736364/, on the last decade of progress in stem cell therapy in Japan. What stood out in the article was that, of the products that have been approved to date in Japan, most are products of Japanese companies, or products of partnerships between Japanese and non-Japanese companies. Of the few approved products by non-Japanese companies, all are big pharma companies, and all have already had their products approved by the FDA.
Finally, it could be that MSB made a strategic decision to focus on FDA approvals first, way back in time when it may have seemed like the smart thing to do. I'm sure when MSB went down this path, they had no idea that they would face so many challenges to getting an FDA approval, or that it would take this long. And they still don't have that first, elusive FDA approval! They've now invested so much time and resources on obtaining FDA approvals, that it makes sense to stay the course.
I'm hopeful that within the next few months this all becomes a moot point. Best of luck.
Cheers,
GMFJ.
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