Ann: MSB Q2 Financial Results and Operational Highlights, page-16

Glad to see that Investors are picking up on the NIH being the sponsor for the confirmatory phase 3 trial for Covid 19 ARDS. This is the first time that Silviu has confirmed they are still on board and working with them towards the regulatory approval EUA stage. As I said before this is significant, because NIH funding in my view will only happen if the FDA tips them off that aGVHD approval is a strong likelihood. Very encouraging news and nice that Silviu was confident enough to mention them by name as their partner for Covid ARDS.

The requested CHF data submission for ischemic diabetic population with raised inflammatory biomarkers is very imminent and almost ready to be submitted (from Silviu’s CC comments). Let’s assume FDA cardiovascular team are actually working on the file and just awaiting the dataset (they already have the top line data provided to them last November), then I can see a quick turnaround and probably another CHF/FDA meeting in April. So we MIGHT know the chances of accelerated approval or single trial approval as soon as April. If the NDA gives the nod, the share price would explode as this is a multi-billion blockbuster indication that could see revenues coming as soon as 2023/4. This would be the event that flushes out the skeptical shorters and basically would be an annihilating event for the long term shorters.

Another significant piece of information that Silviu provided is that they ARE partnering up for the planned CLBP trial and more information on this shall be provided to the market shortly.

So expect announcements on partnerships; CHF data submitted; BLA for aGVHD, etc in the next month(s).

One more thing: BLA for aGVHD to be submitted in “short course”. We need to re-listen to what Silviu said as I definitely heard those words. Sounds to be more likely the submission before the end of March (targeted) and then it’s always a month and half for BLA acceptance and PDUFA date would then be 6-months later, which falls within second half which Silviu indicates…
However I don’t think we’ll need to wait more than 2-months for the full approval after NDA is accepted, assuming the Singapore facility can be inspected in this timeframe. Why? The ODAC is done and FDA had already done 90% of the application review beforehand, so really this is going to be much faster this time around (except the company cannot speculate or guide the market on this as they don’t want to get ahead of themselves and say things that could upset their fantastic relationship which they seem to be enjoying currently with the FDA).

One last comment: Nice to see Silviu’s “camaraderie” with Dr. Eric Rose as new CMO which was very apparent in this call.
Dr. Rose also sounded very bullish about MSB’s prospects in the future. With his distinguished career, I can’t see why he would say something he didn’t seriously believe is achievable.