Call with Mesoblast re CHF interim, page-9

Bear in mind that the existing trial was negotiated and set up under an old framework.

So they could have gone to the FDA without the futility outcome and may have successfully negotiated down the population size and/or achieved conditional approval.

However before fronting the FDA, one must always put their best foot forward. So going in with a futility test that is positive (assuming) on your P3 with half the population size, is relatively significant when asking for conditional approval e.g FDA may approve conditional on the existing population size reading out 12 month results which meet the endpoint. So once 12 month data is released, boom off to market! Rather than getting 12 month data, and then going through the reg process and wasting another 9 months.

That to me is the best possible outcome.

Even with this best possible outcome, I feel they still need a partner to market, distribute etc

The main difference is that we will retain a larger share of the profits as the new partner will not need to invest to complete the trial. They are simply provide marketing and distribution.

With Novartis failing recently, this treatment will make headlines globally if successful.