MSB to dispute FDA finding in Type A meeting, page-301

Moving on to some of the even bigger, more intangible issues, we have here a very small kid on a very large playing field, with a potentially very large weapon. Set to change medicine forever, across many disease streams - haematology, infection, inflammation, respiratory medicine, cardiology and possibly neurology JUST WITH aGVHD AND COVID ARDS ALONE if you understand the extent of the complications being treated. I am not talking about the other products treating heart failure and back pain.

Big pharma must be very very worried about this infringement on their playing field as although MSB can only treat a small number of patients relatively, the biological implications for their second class treatments are massive if MSBs future trials are also positive. More results will be flowing through all the MSB holds all these patents, in all relevant world-wide markets till 2040. This must be a threat to the FDA ie to the US pharma industry. It is possible that requiring MSB to now require a placebo arm even for a paediatric cohort with an unmet need, provides a couple of additional US opportunities:

1)for shares to change hands: why was trading on the NASDAQ for MESO completely flat on Friday night and why did so many shares change hands? Who bought them? I guess they will stay just under 10% so they don’t have to declare themselves but can you find out? Who is moving in?

2) How long can MSB survive without being picked up for a song by a US pharma?

Yes, the best thing would be for Trump to need to have Rem-L and for him to realise that it is the only therapeutic out there that actually controls the cytokine storm. To my knowledge there isn’t anything else out there that can do this.

Do you realise that The Rem-L COVID trial is STILL NOT LISTED ON the NYT therapeutics list ANYMORE. It used to be as evidenced by my very first HC post. WHY IS THIS???? Another reason why I am worried that MSB is being buried.

How far does that fundamental mis-trust of stem cell biology go in the republican camp and how far does that umbrella extend over the FDA now that the administration has final sign off over every decision made by the “agencies”? This sign off is not just administrative. Alex Azar, Secretary of Health and Human Services is in charge. He will be doing the bidding for whichever right minded thinker has thunk his way into this area. Either by way of ideology or pharma ($$$$).

I think that the only way for MSB to be sure of a fair deal is to have adequate efficacy in the COVID trial and for a successful treatment to be needed, by the US so that their dislike of stem cells AND the needs of US pharma is overcome.I would like to say GLTASH but I don’t think it has anything to do with luck. I always believed in the data. The FDA want placebo controlled data and the COVID placebo controlled data will hopefully be good. Even then I want to know who is buying MESO shares.

And ultimately we need exposure in the US. We need the public who have dying relatives to be made aware of positive MSB data once it is available. Which we don’t have yet. So patience for now and hope MSB can last the distance. Then a very good media campaign, which I hasten to point out, MSB cannot run for ethical reasons. They would be crucified by the FDA. We, at HC, may finally have come into our own!If we get a positive read out of the COVID trial, data which is made public, we may need the very best media team ever for this Australian biotech to survive!!! For all the reasons above.

This is all just IMO of course