MSB Trading 2021 - paradigm shift, page-3550

Based on the timing of the release of trial results and what Silviu has told us about the timing of the FDA meetings scheduled for later in the year, MSB should be meeting with the FDA this quarter to discuss the phase 3 CHF results. This is by far the most valuable asset on MSB's portfolio, and also IMO the most likely to attract a big name partner based on mortality benefit shown.

Just to recall what I'm hoping this quarter on this front, all Mesoblast need is for the FDA to say that the results shown in the phase 3 trial are approvable if a confirmatory trial shows the same benefit. That is a massive win if the FDA agree to this, and if this does happen... then we are almost guaranteed a partner in the CHF space (Novartis?) will quickly move in and want the rights to Revascor... because if the results are confirmed (and I suspect they are likely to be exceeded in a confirmatory trial, given the far superior understanding of the patient population they will be targeting)... then this is a multi billion dollar product in their pocket.

I think accelerated approval based on the CHF results is a possibility, but I think the above scenario is the most probable... and I'll take any hint of accelerated approval as a big upside.

Many will have scars from the Ryoncil run-in with the FDA... but I am not going to put these two indications in the same bucket.. where the FDA may have the ability to knock back / disagree on grounds of a single arm trial for Ryoncil... the phase 3 CHF trial was a randomised controlled trial with over 500 participants over several years.. and the p values are as strong as you'd expect to see in any RCT.

When this meeting is going to take place is beyond me, but we may get an idea at the end of April when MSB are due to give an update and a chance for analysts to ask questions... and I'm sure this will be one of them.

Goodluck all