Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-190

March definately is a busy month for us shareholders.

There is a chance Rem-L will proceed to BLA with FDA for aGvHD in children. The meeting is this month.

On the Accelerated Approval for CHF with LVAD, this is interesting. The last thing I heard was the company was going to the FDA with the evidence from the LVAD and the non LVAD ( CHF - Dream trial ) , and it looks like they have come back with only a response regarding the LVAD trial ( probably because the RMAT designation was for LVAD and not CHF ) .

So basically the FDA has agreed on the fact that it is possible that it may agree in the future on on a surrogate or intermediate endpoint for that proposed treatment trial.

MSB has to find and justify what that surrogate end point actually is, FDA have to agree on it, and if there is enough evidence then the product may get approved before any further data gathering.

If there is not enough evidece, or the FDA disagree on the selected intermediate or surrogate end point, MSB may then be stuck in a cycle ( not dissimilar to the current aGvHD re-application cycle ), for years until they produce what the FDA want from the original results, or hold another trial using the agreed surrogate end point.

Reading through the lines.... I suppose they may try and use a reduction in IL=6 circulation by 2 months... or cumulative LVAD weans by 6 months, or 12 month mortality.

Sounds crazy, but mortality reduction could be a surrogate for the fact that MSB has improved the health of the hearts without being able to physically demonstrate this ( because healthy patients are still alive ), and potentially heart re-modelling could take years to be fully in effect - as demonstrated in the Dream HF trial.