MSB Trading 2021 - paradigm shift, page-7783

Thank you for the post. I was curious about this convalescent plasma treatment so read some links. It seems great in theory: that 'convalescent plasma treatment provides passive immunity in patient as opposed to the active immunity that would be induced by a vaccine.' So it's MOA is relatively easy to understand. However in practice convalescent plasma seems to fall short of expectations:'evidence from clinical trials that convalescent plasma does not alter outcomes for hospitalised patients. What's more: 'Convalescent plasma for influenza showed little benefit in controlled human studies'.

So my point is: convalescent plasma therapy has a relatively easy to understand MOA; however has little (or no) effect on clinical outcomes in terms of treating infectious diseases. On the other hand the MOA in Rexlemestemcel is relatively harder to understand; however its clinical outcomes are far superior (and IMO one of the few treatments of last resort that have a survival benefit).

So it seems to date the FDA is far more interested in how a therapy may work on paper as opposed to the results it receives on the front line. The FDA's line of thinking is bordering on INSANITY. More interested in MOA as opposed to saving lives. I think this way of thinking will turn around given the ongoing severity of the pandemic (and our future trial results with be the game changer IMO).

Even more ludicrous, the EUA for convalescent plasma was given because of its superior safety profile (even though it showed little or no benefit on in the clinical setting). In fact, a reviewed literature review paper found (as at July 2021) '250,000 units of convalescent plasma have been administered either as part of an expanded access program, EUA, or through a clinical trial'. OMG! Imagine the amount of extra lives we could have saved if the FDA approved Remestemcel as opposed to convalescent plasma.

If SI pushed this line of thinking maybe he could argue for an EUA as REMESTEMCEL treatment is on par in terms of SAFETY with greater EFFICACY (especially for the under 65's).

Also the FDA may also be missing the mark with Dexamethosone as the Front Line Covid-19 Critical Care Alliance state: 'we believe that the use of low fixed dosed dexamethosone is inappropriate for the treatment of the pulmonary phase of COVID-19'; however instead support that methylprednisone bolus doses do reduce the risk of death in patients with the pulmonary phase of COVID-19. Maybe the majority of the synergistic effect of Remestemel with Dexa in our truncated trial was largely due to Remestemcel? one would have to assume.

I sure hope if I or a loved one was unfortunate enough to progress to the pulmonary phase of COVID-19 that we would be given methylprednisone + REMESTEMCEL as the Standard of Care.

I remain optimistic that Remestemcel will become SOC in ICU Departments soon. Fingers crossed sooner than later.

Good luck to those patiently holding! IMO better days are ahead for shareholders and patients alike.

Have a good weekend