MSB Trading 2021 - paradigm shift, page-736

"Mesoblast has initiated the rolling submission of the BLA to the FDA, with filing of the first module. Therolling process will provide opportunity for ongoing communication, and during this process the Companyexpects it will be able to adequately address any substantial matters raised by the FDA."

The purpose of this statement from SI in my opinion is describing the benefit of a rolling submission . The statement certainly does not confirm any substantial matters at this time .

How the hell was SI clueless??!!
I can insure you , SI is far from clueless.
He went into that ODAC meeting and convincingly answer questions put forward both by the FDA and the ODAC panel.

SI won the opinion of viewers more important he got the
approval from the FDA appointed ODAC panel 9-1 and he managed to educate at least one onlooker , Novartis, the marketers of Jakafi . Obviously he did not win over the current review team of the FDA. Disappointing however not surprising given that they new that the ARDS trial was progressing well and would not be that long before results would be known.

Now I would like to remind onlookers of this announcement .

https://hotcopper.com.au/documentembed?id=uOMxKKzFkiWRTLKhOROKAxjvSTYP5gm%2FwRaZreR7ke92GA%3D%3D


This may help as it discusses biomarkers and efficacy benefit. The key concerns with the FDA. Efficacy would be nothing short of amazing when linked to biomarkers.

"Day 100 survival was 74% in the 54 remestemcel-L children with SR-aGVHD (89% with Grade C/D disease), which compares very favourably with a mortality approaching 70-90% in children of similar severity treated with other therapies."

This along with the ARDS data will need to be lodged with the FDA and I feel confident that MSB will clearly address the concerns of the FDA.

Pledge: "Roll it back now. There is only a very small chance it will get up." Just how sure are you?

Now I would like to continue . Nothing is straight forward with the FDA and it is going to become more difficult in estimation of time lines. If I am correct and the above is considered new and revelent data there will be a delay in progressing to a dispute resolution meeting. My understanding of the process all data must be lodged with the FDAs current review team and response given before progressing to the higher level . All good if we get a positive outcome however if we don't the process becomes more drawn out.