MSB Trading 2021 - paradigm shift, page-7804

So I'll refer to the paper from the ODAC ruling, that outlines the specific concerns they want MSB to address.

This is not down ramping. This is directly related to why MSB is struggling with FDA approval. And as far as I know, they have yet to announce any progress towards rectifying the problem.

They state MSB has demonstrated a strategy for batch to batch consistency and potency. But they say it's not sufficient, and that it has yet to be validated. They need another method (picture 1)

They go on to recognise that this is very challenging for MSCs, as they're derived from different donors and are very heterogenous between batches (the cell numbers, types, etc).

So they say either potency assays based on a reasonable mechanism of action could be used. Unfortunately, the science isn't there. Without some major breakthrough in knowledge of how these cells work, that likely won't be achieved any time soon.

The second is by meeting primary endpoints in large, well powered trials in humans. Again, unfortunately, MSB has yet to do this. (picture 2)

They go on to say that as the mechanism of action has yet to be demonstrated, the relationship between in vitro and in vivo potency can't, at this stage, be linked.

What that means is that the FDA will not trust laboratory assessments of batch to batch potency. Which means until MSB figured out how to demonstrate the mechanism of action in vivo, or start demonstrating an ability to meet primary endpoints in robust studies, they will struggle to get approval (picture 3).

What does this mean for the company?

This means they need to really gear up their research and figure out how to demonstrate an in vivo mechanism, or they need to undertake further trials to meet primary endpoints without this post hoc business.

Have they demonstrated they are doing either of these things? These are very real concerns by ODAC and for people here to brush this off as "the cells work, just a matter of time" is extremely naive.

This will take a lot of time and a lot of funding, both of which MSB is lacking at the moment.

I suggest holders go back and read the ODAC verdict, as it's actually quiet concerning (as someone who wants the company to succeed).

The nuances are difficult to understand if you haven't run cellular assays yourself. There's a reason I have done a lot of research into this company and yet still sit on the sidelines.

DYOR. I'm happy to be corrected by those who may know more about the process.