2023 The Final Countdown, page-3371

I would temper your expectations on timeframes around this .... mid September could mean anywhere from 10th - 20th September (you will note a date wasn't used in the CC and the messaging was consistent throughout - mid September) .... and of course I cannot see Mesoblast updating the market without written confirmation from the FDA about what has been agreed to in the Type A meeting - this can take up to 30 days from the date of the meeting


..... the FDA protocols for Type A meetings can be reviewed at the link below



https://hotcopper.com.au/threads/mesoblast-cc-transcript-31-8.7562026/?post_id=69663643


The lead indication for remestemcel, our first generation platform is pediatric and adult steroid refractory acute graft versus host disease. We have developed substantial data that has been presented to the FDA. We will -- let me talk about those in a couple of minutes, but we do have a very important Type A meeting with the FDA mid-September -- scheduled for mid-September now to discuss our strategy for product approval.

Next slide please. Slide 5 -- Slide 6, this slide summarize the regulatory status for any stem cell in pediatric patients with GVHD and the upcoming Type A FDA meetings, which is now scheduled for mid-September. During the six month BLA review, we made substantial progress towards bringing this cutting edge product to market with having completed a comprehensive FDA inspection of our manufacturing process and the facility where our cells are being manufactured.


The Type A meeting with the FDA is scheduled to be held in mid-September, and we will be laying out these exact strategies. We proposed providing FDA with additional potency assay data to provide the link between Phase 3 product and the current commercial inventory. We also proposed providing FDA with new clinical trial data in adults, which could also support the pediatric indication.




https://www.fda.gov/vaccines-blood-...re reserved,address an important safety issue.


OTP Type A Meetings