Pretty frustrating reading these forums. I want to make posts but a lot of the time I don't see the point, because if people had just read what has already been discussed a lot of their concerns would be alleviated. There is a serious lack of object permanence in some of the investors on this forum and some people should really look long and hard on their emotional investment strategy.
I have already discussed that this company was never an 'if' company, but it is a 'when' company. Therefore, my approach was that it was better to have skin in the game throughout the journey so you don't miss any of the many potential boats. The FDA could have approved GvHD last year and the company could be in a totally different position. Similarly, they could have deemed this ARDS trial was sufficient for an EUA. While I hoped and believed this would be the case, it was never the pivotal reason for my investment thesis. There is even an off chance that CLBP and CHF can be approved off the individual trials - so to me it's worth having a holding while finding that out. If both of these indications require another trial, will I be screwed? No, because I did the risk analysis DD and invested accordingly, I acknowledge the risk of a short-term loss of value for the security of not missing the boat.
With regards to the more pressing 'when' questions: GvHD and ARDS, we are in a pretty good position. I don't know if anyone is still arguing that when we achieve approval in GvHD we should be back around ~$4-5, and when we get Covid ARDS we could see an initial movement ~$5-10.
They are meeting with the OTAT in Q4 CY21 for validation of their potency assays, which will enable a 6-month resubmission for GvHD and the initiation of the secondary Covid-ARDS trial. So if OTAT validated the potency assays, which we have had positive indications for, MSB should have their first commercial product in the US in Q2 CY 22. That's a minimum of 3x in under a year hinging on the outcome of the OTAT meeting. Find me many other stocks that have a really solid potential for a 9-month turnaround 3x return.
Not only that the OTAT committee will enable Covid-ARDS. This trial is already having its protocol drafted with the FDA and Novartis, so it will already have ethics by the OTAT meeting and can hit the ground running. As I have already discussed, I suspect the primary endpoint should be something like all-cause mortality at day 60 in under 65s in patients also on dexamethasone. You know, that subset we saw a 78% reduction of mortality in (14% vs 48%, HR 0.23,95% CI (0.080, 0.681), p=0.0037). I have also already discussed how these stats work, it would be mad to bet against Remestemcel-L repeating some substantial level of mortality reduction in this group, so again it is a 'when' question in how many participants we need to see this effect. I believe MSB that the FDA is also feeling the urgency on this, and so I expect a DSMB to be reviewing the data as a priority at regular intervals. We recruited 227 participants in 8ish months last time, I reckon we only need 100-150 to demonstrate a sufficient efficacy to trigger the EUA, I think MSB will be motivated to continue the trial regards to further characterise the effects on outcomes outside of mortality. This means the EUA could be triggered by Q2/3 CY 22 assuming an immediate start following a positive OTAT. That means we are now looking at well over a 10x in under a year which would be supplemented by the Novartis partnership progressing. Ongoing Novartis discussions have been confirmed by multiple sources, why would you be helping design a trial you're not planning on performing?
I saw someone that the FDA has basically just said to "follow the process like everyone else and we will review the data like everyone else and maybe approve you". That's not really true. This has caused FDA engagement and prioritisation, and a statement that if we see similar efficacy in another trial we will get a EUA. Remember that p-value?
Also - something I haven't really seen people discuss. These potency assays - they will be pretty novel right? Only some aspects of them will be in the public domain, the process/machinery/and markers involved in the development of these potency assays will likely be patentable. I'm speculating but I believe that MLC companies that are trying to get regulatory approval will probably have to develop components of these assays themselves in a way that is distinct to MSB, adding another barrier.
I have also previously said that if you were actually invested in the fundamentals, you would be making the most of dips as a way to average down. People complaining that they have lost since investing at $5 could probably have got that down to $3-4 by now. Why are they not doing this considering everything I have just said.
It is really unlikely that MSB is going to run out of cash, but there may be a capital raise beginning of next year depending on if Novartis/other partners have brought on board their cash. They had no problem raising US$110 million at A$2.30 let alone the current ~1.60. As I say though, it is likely that we will not need another capital raise, it will depend on partnerships and how much comfort the senior leadership team wants to float.
To be honest, I don't really care about people making what are potentially poor investment decisions by selling at the bottom. It lets me average down and increases my multiplier. I also suspect that they will be part of the masses who buyback on news and hype, which will just exaggerate the movement further. It's the same reason why it is good the company is so shorted. Major positive movements will be very very volatile.
In summary:
CHF and CLBP may require another trial, decide if you want to be in for that ride or not and invest accordingly
CHF data will be positive
Novartis doesn't look like it's going anywhere
Massive potential return in under a year dependant on OTAT
Some people need to just put it in the bottom drawer and walk away
Cheers, Gang Gang
MSB Price at posting:
$1.61 Sentiment: Buy Disclosure: Held
(20min delay)