Ann: MSB Files for FDA Designations in Congenital Heart Disease, page-4

@DocMcstuffins

https://www.jtcvsopen.org/article/S2666-2736(23)00304-2/fulltext

You may recall I was incredibly encouraged by the results of a small trial whose results appeared as a “pre proof” for the last month on the internet. Rather than steal the thunder of an eminent bunch of scientists working at Harvard and Bostons Children’s Hospital , I decided to wait for formal publication. As a Phase 1/2a randomised controlled study, I am Doc will be less concerned about the placebo effect on the 5 month old babies being treated and hopefully overjoyed that Mesoblast has managed to double the left ventricular volumes by injections of MPCs in babies who get surgery to avoid the Fontan procedure. Now just think about that….ejection fraction between randomised cohorts was very similar and yet our ability to stimulate growth in cardiac tissue versus control is statistically significant obvious for all to see.

I have started following the career of Sitaram Emani MD enough to realise that there have been some pretty special emergency use examples of the effects of MSCs on this condition….but perhaps the Doc can explain the science to me without using the word luck this time ? Well Silviu has always talked about the continuum of evidence in a whole range of heart conditions…although a phase 3 is required , this is an obvious candidate for “accelerated approval” as it ticks many boxes. OP



Please do not rely on the facts or opinions expressed in the above post when making an investment decision. Mesoblast may need to find additional finance in the coming quarters, requiring either selective licensing deals, monetisation of existing royatly streams , partnerships or issue of equity etc. etc.