We all know that supply is going to be an issue. Same goes for timing of the epidemic, and whether there will still be any or many patients when MSB finally gets approved (assuming it does).
So if we HC posters are so acutely aware, we really can and should assume that MSB is, too (so aware, indeed, that they conducted a CR to get ahead of the problem and get production capacity up ASAP).
On balance, I haven't seen anything about this company that says they aren't thorough planners, and they seem to approach most opportunities aggressively, but with an edge of caution and conservatism. They are true "under promise and over deliver" operators if I have ever seen them.
Given that, I think we can assume, too, that MSB is working on the supply problem on a DAILY basis, has already as much as possible ramped up production with current methods and technologies, and will continue to churn out as much product as they can, by hook or by crook, to maximise the opportunity if/when they get approved.
MSB's planning for post-approval supply will, I further assume, be based on (1) realistic calculations, timelines and need for possible investment and/or additional partnering to bring new production capacity online, etc., and, very importantly (2) the best possible calculations on likely COVID cases, upon approval, likely assuming that that COVID-related ARDS WILL decline over time (though cases are on the upswing in many states, what with protests and relaxing of control measures, so those "best worst-case scenarios" ("worst best-case scenarios?") may also be too conservative about ARDS cases dropping off soon).
I would assume, too, that MSB will have analysed the larger opportunity and will be able to provide realistic corresponding details on flu-induced ARDS, too, which would seem a prime candidate for off-label use.
All of that information is going to form a key part of any discussions with both the FDA and with any potential pharma partners. They will both want clear answers as to number of doses on hand post approval (where I imagine, again, that heavy production is ongoing and will remain so for the foreseeable future), production capacity, etc.
Keep in mind, too, that these potential partners aren't naifs, either. They will have their own calculations and views on these same issues which, together with MSB's information, will form the basis for any deal--and any royalty rate--that is eventually set.
From my perspective, the biggest problem for ME is my lack of insider knowledge combined with my impatience.
Those two things create a natural tendency for me to try to fill the information vacuum with speculation, or worse yet, fret alot about things it's likely safe to assume MSB is already thinking about, hard.
I can always calm myself down by remembering that I trust SI and his team are approaching this opportunity realistically and professionally--including by identifying major risks, and taking all steps possible to minimise those risks, and on the other side of that same coin, identifying major opportunities, and taking all possible steps to maximise those opportunities.
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