FDA ODAC Meeting Material discussion analysis, page-177

I think you nailed it on the head, and that is where I feel the market has got it wrong. The manufacturing discussion is not being voted on, and I think the FDA must recognise that they themselves do not know all the answers... and that there may never be a way to satisfy the criteria ... for drugs you can easily measure the active ingredient in each batch... and get comfort that you can get a known clinical benefit... but for MSCs... it might take decades to figure it out. So while there is some indirect relation, I don’t think it is the main session that will address the question being voted on.

Which leads to the question they are voting on, and I agree the PM session is where they will be getting right into the serious stuff and that is where I think MSB will shine... and I’m keen to see what the market will do if the votes come out as a resounding yes to that question... I’ve got the feeling that isn’t priced in at all right now.