"Now once we submit it, it's a process. That process includes...

"Now once we submit it, it's a process. That process includes the requirement for inspection of the manufacturing side. And so all of that needs to be performed and manufacturing site in Singapore was not inspected during the first 3-year process. So that still remains as an outstanding item and will probably drive the time line to approval. Statutorily wise, it's the maximum time that resubmission can result in approval in 6 months. So we are working towards an approval in the second half of this year and putting our commercial team in place to be prepared for a successful launch."

Given how hopeless SI has been with time estimates and the ambulance chasers hovering around, Mesoblast would now be very cautious in their time estimates... yet, SI has stated above "approval in the second half" of this year.

Working backwards and giving some room for error margin, I would like to think that Mesoblast needs to resubmit the BLA within the next few weeks (Max one month).
There are a few things that push me towards this timeline:

• it previously took 2 months from announcement of the BLA submission to the FDA accepting the BLA submission
• the PDUFA date doesn't commence until the FDA has accepted the BLA submission
• the BLA re-submission may need some little tweaks - and that needs a bit of time to perform corrections
• Lonza needs to be informed and be prepared for the site inspection

All the above needs to go smoothly to get the "approval in the second half" of this year.
You want to give yourself some breathing room - so the BLA re-submission needs to be announced shortly otherwise this expectation of approval is at risk.

Get on with it Mesoblast - bring it on!

GL MSB'ers