June 24 - MSB % of portfolio AND + or - %, page-57

Yes there is definitely a Big Pharma element who I am sure are trying to slow or stop MSB commercial plans - some of the downrampers on here are most likely part of those efforts.

It has been a concern for sure, however there has definitely been a turn of the tide in support of MSB in the last 6 months as we have talked about on this forum.

The FDA looks to be more supportive now ….why????

Have the FDA simply seen the light in the new data??? Yes potentially this could be all it is, however I don’t think it is completely that.

I think key additional partners have helped MSB here heavily with the FDA….but lets not call them partners, let’s call them “clinical champions”.

As we know there are various clinical networks and bodies in the US that are connected to other influential people and bodies…ie the FDA and their staff as well as other government and political figures for sure. Ie. BMT CTN, Mount Sinai Hospital, Texas Heart Institute, Cleveland Institute, Surge Centre etc etc. These are all high profile clinical bodies which MSB have built up relationships and “partnerships” with over the years and I think they collectively have all added weight to the discussions with the FDA. Also validation in clinical Journals is needed weight as well in these circles and MSB therapies have been published and this is also like a partner in support.

There are also connected people like Krause, GG and other members of the BOD who know people high up the influential clinical and government chain I am sure and I am sure they have all pushed MSC’s forward collectively.

So while we don’t have a Big Pharma’s as a partners as yet in the US…. I think on mass MSB have a lot of “partners” who are “clinical champions” that are adding their mass weight behind MSB and MSC ‘s now and championing the proven therapeutic need in the US now and the FDA have started to listen to this little Australian company with the help of the entire US clinical partners/champions mass behind them.

In the end I think MSB have realised they had to positions themselves with these key US bodies and connected clinical champions to get their products through turn FDA. Krause‘s appointment was one clear sign of this revised plan.