Hi @eyeswideopen / @The Yankee, yes, and CEO Itescu commented on...

Hi @eyeswideopen / @The Yankee,

yes, and CEO Itescu commented on the extent & need for MSB to be proactive with that payer engagement in the Q2, 2023 Earnings Call on May 25 last which (at that time) was still anticipating the launch in Q4.

The relevant extract:

" Next slide, please, Slide 22. So those – having summarized those data, the new data that formed part of the BLA. Let’s talk now about our go-to-market strategy with the assumption hopefully that PDUFA after August is gives us a positive outcome. The pre-launch activities that are active and ongoing are engagement of the highest transplant volume centers with experience using Ryoncil.

Non-promotional activities include profiling of the centers, education on disease awareness, unmet needs, and support for payer engagement. We are currently hiring select positions to build out a small commercial team. The key activities of this team are market access to initiate payer outreach, medical, providing education to payers, corporate leadership initiating engagement with the top 15 centers and regional sales directors leading center profiling. Importantly, manufacturing preparation has been ongoing throughout with $31 million of remestemcel-L pre-launch inventory in hand. " (underlining added)

and again, later:

" The launch is going to be a targeted launch initially focusing on the highest volume transplant centers, but we should be ready to launch as soon as we’re approved. We have already got inventory in place.

The discussions are ongoing now with payers. Reimbursement will take some time, of course. But we should be in a position to initiate launch as soon as we’re approved, although the pace of the launch is going to be staged."

And then it was mothballed & we all cried in our beers (a lot). @cklamov posted the entire Earnings Call transcript here: Post #:67988281 - it's worth re-reading IMO.

However, as I understand it the work's largely been done - under Chairman Swedish' non-executive tutelage, I feel sure.

Cheers
GLTA(LT)H