The 100 day results would've been logged earlier this week. They will be released after the analysis has been done. On May 8th, MSB said:
"Key secondary endpoints include survival at 100 days, the results of which are expected to be read out shortly, and safety and survival through 180 days."
So, if you want dates, the GVHD 100 day results will be out "shortly". The 180 day GVHD results should be out around early-mid August.
The 28 day GVHD results met the FDA's primary endpoint (and met it spectacularly well, based on the tiny 0.0003 p-stat, as usually a p-stat has to be below 0.05 to be regarded as significant!). So, we have very high likelihood of approval, as long as the 100 day and 180 day results show continued survival. You can't understate how spectacular this is - we have the first MSC product to have beaten the FDA's primary endpoint in a phase 3 trial! This lays to rest any doubts about the potency of MSB's cells and validates its manufacturing processes. And it's in an indication where there is no alternative treatment (after steroids have failed) and it therefore meets the requirements the FDA is trying to advance in terms of 20th Century Cures Act ("curing a serious or life threatening disease or condition, and there is preliminary clinical evidence indicating the potential to address the unmet medical need"). It is already approved and being used in Japan and high likelihood FDA will give it "eligibility for priority review and accelerated approval" and it'll get reimbursement from health care system.
The 100-day results could even generate more interest amongst stockmarket pundits if they show similar results to the 28 day and survivability over a longer period of time (even though this is a secondary endpoint). As you say, the stock has been in a holding pattern - right on the 100 day and 200 day moving averages, so even a small piece of good news could push it through these levels and see a sharp move higher.
So, apart from the 100 day results and 180 day results of GVHD - there is also the "accelerated approval" date from the FDA - nobody knows exactly how accelerated it will be, but they've made a song and dance about it, and kids are dying if they have refractory aGVHD - so the approval date could be relatively soon after the 180 day survival results.
For me, the really big date is sometime in the 3rd quarter this year when we get the 12 months readout on the 159-patient trial in end-stage heart failure with LVADs. RMAT designation from the FDA for these patients with LVAD's has already been granted - and MSB has said they "intend to meet as soon as possible with the FDA regarding the company's development strategy and seek approval on an acceptable regulatory approval pathway".
Obviously, each approval and meeting of endpoints makes a big partnering deal more likely, and heart would be a much bigger deal than aGVHD.
To those who are still debating debt vs equity vs partnership deals - the landscape is very different now compared to even 12 months ago. They are now well advanced on phase 3 trials. They have plenty of cash to get through to key trial results where it is proved up and de-risked enough for big pharma to be prepared to consider offering big bucks. So debt is appropriate (if required) - as equity dilution is far too expensive at this point, potentially just in front of a big deal. Of course, a deal may not happen, but obviously people like Hercules think it is likely - or they'd be at risk of getting their loan repaid, and they don't have the equity upside.
So, the final dates that are important are the dates that a big heart deal might be announced. That could be any day, but more likely around good results from the heart trial in the 3rd quarter. MSB have disclosed in their quarterly cash flow statements that partnering could happen as early as the next quarter - this isn't new to the latest statement , but it show they consider themselves ready to complete a transaction if the right one comes along, and continued good trial results can only make that more likely, not less: "Mesoblast is in advanced negotiations with selected pharmaceutical companies with respect to potential partnering of certain Tier 1 product candidates. If Mesoblast enters into a binding transaction in the next quarter, it expects that one effect of the transaction is that its cash reserves are likely to increase. Mesoblast does not make any representation or give any assurance that such a binding transaction will be concluded."
We're getting close, but even if there is a considerable share price rise upon announcement of the first partnering deal, the upside will still be potentially huge after good results are released in coming years for other indications. We are only at the first stage of what could be history making technology - i.e. starting small - the GVHD will start in kids, then gradually move to adults (a market twice the size), heart will start with co-injection of MSB's cells along with an LVAD (US market size 5000 patients), then gradually go out beyond this to all stage 4 and a significant proportion of stage 3 CHF sufferers (market size over 1million patients). Then back pain (market size 3 million). Then the 2nd tier products! And this is all just for the US - imagine what will happen if the Chinese decide this should be a high tech growth area that they want to grab in the early stages (like they have with solar panels etc).
So don't get too tied up on timing in the next 3-6 months - it will be important in establishing the company on solid funding ground, and proving if the technology works but it is very early days - there could be a multi-year continual appreciation in the value of the company as new indications go through trials and as analysts remove big discounts on the valuation of these new treatments.
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