My understanding is that the meeting would only go ahead if MSB was not satisfied with there responce.
Well on that basis as at the last CC on 31 Aug they must not have been happy with the FDA's response since the CRL ...there's a surprise ... lol
All indications in the CC and the subsequent Q & A segment implied that it was full steam ahead for the Type A meeting and I just don't see Mesoblast reporting back to the market until they receive written confirmation from the FDA ?
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.
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://hotcopper.com.au/threads/mesoblast-cc-transcript-31-8.7562026/page-2?post_id=69663727
Dr. Silviu Itescu
The size of this trial is relatively small. And again, until we have full agreement with the agency, we need to be a little bit circumspect. But we are looking at per arm something like 60 to 70 patients, something like that per arm. And the overall cost, given that we are working with the CTN, it's going to be in the mid single-digits, that sort of thing.
So, we are talking about relatively inexpensive trial costs. And so when you say, how much will this offset around 25% cost reduction, over the next six months, a very little will offset good reduction. That's sort of being fairly circumspect.
But obviously, the detail of this will be, I will be able to talk to you in more detail after the Type A meeting.
Dr. Silviu Itescu
Well, that's exactly right. The primary reason for the CRL was that the FDA remains wanting to be convinced that the product in our current inventory that is to be for commercial launch is substantially the same as the product that we're using in the Phase 3 trial. And our potency assay needs to be substantially the same potency assay as was used in the Phase 3 trial in order to demonstrate that the two products are the same. We have those data that are currently being developed. Some are in place. Some still need to be added. We expect that in the next few months we will complete those data.
And that is part of the discussion of the upcoming Type A meeting.
(20min delay)