Regenerative Medicine and Cell Therapies Virtual Event, page-21

Some thoughts from David Oxley's panel sharing -

1. Cells are 'homing' - mentions April IND - Back then, mortality was in excess of 90%!

Remember - 75% of them off ventilators and out of hospitals in 10 days
Contrast to the neighbouring hospitals - ~9% probability of survivability with SOC

30% interim - pleased with result
45% interim - sometime around end Oct

"GVHD is the MOTHER OF ALL OVERWHELMING INFLAMMATION"

Acknowledges that MSB does not work in a vacuum - vaccines are equally important - its more the non-ARDS infected, but the clear focus is on the ARDS infected people (on ventilation)

Right now - its a 60% probability of death if you're a C-19 ARDS patient.

'Great hope in the office' to see a close replication of results from the pilot study (Mt Sinai)

Q: What is the wall in the federal government and what can be done?
A: (paraphrased) In terms of BARDA - 'fantastic platform' where the funding is the enabler of commercial-scale manufacturing, but MSB is self-funded. (meaning, we're good for $$ thanks). Any fortune with the studies that looks like Mt Sinai would lead to accelerated approval. Notion of a 'national stockpile' - there should be something available for them under the 'warp speed' arrangement (could we see gov't funds help to build more inventory??). A local stockpile in USA makes sense. Funding has to remain and inter-agency collabs should continue. Focus does need to be on therapeutics for the infected, as there's already significant investment for the uninfected (i.e. vaccine research in terms of booster shots, likens it to how you'd treat the flu).

Now its time to think about BARDA pivoting to therapeutics and whether they can be accelerated out of gestation to commercialization.

Loved how he shone light on Temcell's journey in Japan in terms of the 'spirit of collaboration and cooperation' between government and industry that led to approval and commercialization and how FDA is doing likewise and could do better.

In terms of market share, 40% of doctors and patients in Japan have embraced Temcell as their first line of care. That's worth noting.


In summary, I think we can reasonably assume that BARDA might play a role in terms of accelerating the manufacturing of Rem-L in America for C-19 ARDS. This is huge, because this is going shine a very bright light on Rem-L and its efficacy in treating C-19 ARDS.