@francescaI’ve previously covered everything and there aren’t any direct questions so I avoid clogging up the boards.
The price has fallen on heavy shorting in Australia recently. Since the end of August, shorts have increased by more than 15m to 54.5m Aussie MSB shares. That’s the equivalent of nearly 11m ADRs. That will eventually reverse and is now “frozen” or delayed buying. Volumes in the Aussie market are generally less than 2m shares currently (outside of the big shorting days or short covering days). On the big short covering days in the past, the share price has jumped substantially. So they are taking a big risk being short with so much going on in this final quarter of the year.
There were some negative comments from shorts this week about a business development guy “leaving” Meso to go to a tiny firm. He was a consultant to Meso (maybe 1 day a week) and still is, and he has indicated he is still bullish about Meso’s prospects and remains as a consultant. Shorts tried to beat this up into something but it’s absolutely nothing.
Meanwhile the American Heart Association’s scientific sessions have given Emerson Perin a “late breaking” talking session on 14 November. That is usually reserved for important papers which have just come out - most other presenters at the world’s foremost heart association will be presenting papers which were lodged months ago.
This is a strong indication that EP’s long awaited article in the NEJM is imminent - maybe timed to come out around the time of the conference.
The AHA conference usually has 15,000 heart specialists attending - so this is a very big deal for Meso, though I had previously flagged it was possible given EP’s comments back in April.
Meso haven’t yet officially given us dates they’ll be meeting the FDA this quarter. I had hoped October for aGvHD and November for heart and back pain. Let’s be realistic and guess mid- November (ie mid-quarter) for all 3 in the absence of any guidance. The FDA has been rushed off it’s feet this year and is understaffed by its own admission. If the meetings are a month earlier or a month later it won’t affect my valuation. They may time heart to come after EP’s presentation, who knows? I’m guessing. Just to say it doesn’t make any difference to a long term holder.
There have also been some recent papers released which continue to build on Meso’s science but I don’t have the space to go into them here. I suspect they will form part of the FDA submissions this quarter - we already know the results are spectacular and these papers build that out.
Do you really think the AHA would include EP’s work as a late breaker if it wasn’t significant. Will it be bad news or good? He has already told us on his video talks that he has had spectacular results and he thinks it will change how we treat heart disease and he’s the director of the Texas Heart Institute - one of the biggest in the world. He’s a big hitter with great results presenting to the biggest group of big hitters in the world!
My money’s on a real scramble by potential big pharma partners in the heart indication once EP has done his presentation - they are already talking to Meso as the Prof has previously told us, but they’ll all be listening in to EP’s talk and we should have the NEJM article and the FDA giving us a pathway to approval meeting around the same time.
A new partner on heart should give Novartis a kick along - they would be silly to miss the chance of getting heart as well as ARDS and option on aGvHD as it would be a great fit with Entresto. However maybe the Prof wants to diversify partner risk and that would be sensible given past partners have been taken over by boneheads and that then throws all planning off the rails. Ultimately worked out ok (actually worked out great after a lot of pain) but why put all your eggs in one basket. Of course at present we’d be happy to see any partnership with Novartis - so I’ll leave it up to The Prof.
I don’t know if Novartis are waiting for the aGvHD meeting with the FDA, but at face value they are still waiting on analysis of results - I take that to mean bio marker data, manufacturing potency assays and consistency ie all the things the FDA OTAT want to discuss in the meeting. If the meeting is mid-November (guess) then all of that data would need to be out by the end of this month and in theory NVS may complete the deal then.
So this quarter remains huge potential for Meso, but that’s what I wrote last time. The Prof confirmed that in his latest interview. He also confirmed in the interview that Novartis remains a partner and that he expects the closing condition to be completed soon. Just because some shorts come in and smash the price down doesn’t change any of that, nor my valuation.
While it is quiet at present, the only news which has come out has been positive and confirms Meso is still moving forward.
(20min delay)