Ann: FDAs OTAT Agrees to Primary Endpoint for Back Pain, page-135

It may not be apparant to some, and those reading today's announcement thinking we won't get any positive news for at least another 24 months on CLBP are missing a big piece of the picture.

Now that the FDA have confirmed the trial design for the second phase 3 trial for CLBP, the next step (within months) is for Mesoblast to settle on the partner they want to work with to fund the second phase 3 trial.

That means rights to this asset/program ex EU / Latin America are up for grabs.

That means upfront payments and milestone payments and of course funding for the trial itself, all in early 2022.

The EU/Latin America is a relatively small market compared to the US.. and that had US$15m paid upfront with milestones prior to approval of up to US$112.5m, and post marketing approval milestones of up to $1bn.

Extrapolate that to the ex EU/Latin America markets.. and you can see a deal easily matching or more likely eclipsing whatever Novartis were offering for ARDS.

It may also be lost to some that the FDA just turned the apparant failed first CLBP phase 3 trial, into a successful one by changing the primary endpoint to a single 12 month pain score. Which when they take to approval, the FDA will look at the pain score across the two phase 3 trials and treat the opioid and function data as secondary endpoints.

So we now have one successful phase 3 CLBP trial, and so we only need one more to replicate the first trial .. and this product will be in the market. But it may have competition as to who is first, because Ryoncil is in the box seat.. but CHF is the dark horse that may just surprise us all.