It was my understanding that they
already had a small commercial team in place and 'would' expand upon that up to
15prior to PDUFA / launch date / approval date from comments in the last CC .... I would also add that advertising today isn't going to have a sales team in place by tomorrow if it is approved then so again why not wait one more day if you don't know the answer when you already have a commercial team in place - supposedly up to 15 if you believe these comments from the last CC ?
For these reasons I believe that Mesoblast has the answer and that is why they pulled the trigger this morning for these 7 additional roles
"We have the commercial team that is currently in place and building.:"" It will not need a very large footprint""but we should be ready tolaunch as soon as we’re approved" (
if approved tomorrow these job advertisements wont provide the staff for this 'launch as soon as we are approved'
"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." (
again if approved tomorrow how can we be ready to launch if we don't already have this commercial team in place - we do .... and of course if it is going to be staged as indicated then surely it would be prudent to wait one day longer to list the job advertisements if we don't have an answer from the FDA)
Unidentified AnalystHello, everyone. This is Carvey [ph] on for Louise Chen from Cantor. Thank you for taking our questions. First, your PDUFA date is fast approaching. If approved, how quickly can you commercialize the product? And secondly, how are you thinking about OpEx for the rest of 2023 and 2024 fiscal years? Thank you.
Silviu Itescu
We have the commercial team that is currently in place and building. It will not need a very large footprint.We expect to have about 15 or so sales force in place at the time of launch. 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.
(20min delay)