MSB 2022 - The road to commercialisation, page-6

Hey @ddwn

I haven't seen this version, but I've read through previous versions. Not sure exactly what has been updated, but key points still appear to be consistent with my understanding.

You are correct, this should be a class 2 resubmission and correlates with what Mesoblast have advised that a resubmission with a 6 month review time (see ASX announcements).

In terms of how long a resubmission will take to review, really depends on what the FDA need to consider and/or perform. I assume they've done an inspection of the manufacturin facilities in Singapore, but I can't say for certain... though the fact they've raised CMC items suggests that they have. But typically before any approval, an indept inspection is required... and with the amount of focus on manufacturing of the cells, I suspect the FDA will not pass on the opportunity to inspect Lonza's manufacturing facilities.

I do agree though that if we are correct to assume that the FDA are not going to push back or debate on efficacy, given the successful phase 3 trial and the 9-1 ODAC vote.. then the focus may only be on manufacturing and analysis of the MOA/CQA's/Potency assays link to the phase 3 trial data. If that is the case, then yes I'd expect it to be a shorter review time than 6 months.

One thing that should be noted is that we shouldn't get too ahead of ourselves in terms of the FDA accepting the resubmission. As this document stipulates, so long as Mesoblast provide a response to the two items in the CRL, then the acceptance of the resubmission does not assess how acceptable that response is, merely that there was a response provided.

So while it appears Mesoblast are doing a lot of work to address point 2 i.e .manufacturing, without knowing exactly what was said between Mesoblast and the FDA / written in the CRL... we can't be 100% sure that by addressing point 2.. that the FDA will be happy with point 1 as Silviu suggests. Though of all people, he would be the best to make that determination outside of the FDA... so without more information, his 'belief' that it will be sufficient is all we have to go by... and I'm sure many who have been burnt will not be as trusting, which is absolutely within their right. No issues there, as nobody really knows how certain his statement is... though we know he can't exactly come out and tell us that he is 100% certain of anything when it comes to the FDA, not even a meeting date... as to not appear arrogant or overassuming.. both things the FDA may react negatively to. Anyway no point labouring on this particular point, because it's totally up to the FDA and we can only make an educated guess.. based on what Mesoblast tell us.

But in terms of your initial question on timing... I actually have a feeling there will be so much going on in 2022, that time will pass quite quickly, in amongst other important happenings in 2022... across all indications i.e. CLBP trial / partner, CHF trial / partner / BLA, COVID ARDS trial / partner, Crohn's partner / trial. There will be a lot to discuss and ponder.. and the PDUFA date will probably be before us before we know it.